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    • abstract_of_study<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • study_title<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • laymans_summary<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • short_titleUt qui nulla ut recusandae Om
    • protocol_noECCT/24/06/01
    • reference_no(null)
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    • date_of_protocol10-06-2024
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    • disease_conditionArchitecto enim minus voluptatem odit obcaecati sapiente sapiente eum cupiditate vero
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    • product_type_chemical_nameAdria Kane
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    • comparatorYes
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    • email_addressjkiprotich@intellisoftkenya.com
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    • declaration_applicantTest Conta ct
    • declaration_date111-06-2024
    • declaration_principal_investigatorTest National Investigator
    • declaration_date211-06-2024
    • placebo_presentYes
    • study_objectives<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • principal_inclusion_criteria<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • principal_exclusion_criteria<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • primary_end_points<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
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    • scope_others0
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    • staff_numbers<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • other_details_explanation<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • other_details_regulatory_notapproved<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • other_details_regulatory_approved<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • other_details_regulatory_rejected<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
    • other_details_regulatory_halted<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
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    • notification<p> Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p> <p> Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p> <ol> <li> <p> <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p> </li> <li> <p> <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p> </li> <li> <p> <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p> </li> <li> <p> <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p> </li> </ol> <p> The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p> <p> Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>
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      • content<h3 style="text-align: center;"> <span style="font-family:bookman old style,serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/06/01 : Amendment Approval; </u></strong></span></p> <p> <strong><u>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</u></strong></p> <p> <strong><u>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</u></strong></p> <ol> <li> <p> <strong><u><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</u></strong></p> </li> </ol> <p> <strong><u>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</u></strong></p> <p> <strong><u>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</u></strong></p> <p> <strong><u>.</u></strong></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. sample<br /> <a href="http://45.79.161.190:8080/attachments/download/852">icon.png</a> dated 8th July 2024 Version v1<br /> 2. test<br /> <a href="http://45.79.161.190:8080/attachments/download/853">screenshot_from_2024_07_08_11_28_10.png</a> dated 7th July 2024 Version v3</span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study </span></p> <p> <strong>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</strong></p> <p> <strong>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</strong></p> <ol> <li> <p> <strong><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</strong></p> </li> <li> <p> <strong><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</strong></p> </li> <li> <p> <strong><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</strong></p> </li> <li> <p> <strong><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</strong></p> </li> </ol> <p> <strong>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</strong></p> <p> <strong>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</strong></p> <p> <strong>.</strong> <strong>(ECCT/24/06/01).</strong></p> <p>  </p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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      • approvermanager
      • approval_date2024-07-08
      • expiry_date2025-06-21
      • statusamd-1
      • submitted1
      • deleted0
      • deleted_date(null)
      • created2024-07-08 18:50:56
      • modified2024-07-08 18:56:21
    • 1(array)
      • id8
      • application_id77
      • approval_noPPB/ECCT/24/06/01/2024(8)
      • content<h3 style="text-align: center;"> <span style="font-family:bookman old style,serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/06/01 : Amendment Approval; </u></strong></span></p> <p> <strong><u>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</u></strong></p> <p> <strong><u>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</u></strong></p> <ol> <li> <p> <strong><u><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</u></strong></p> </li> </ol> <p> <strong><u>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</u></strong></p> <p> <strong><u>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</u></strong></p> <p> <strong><u>.</u></strong></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. sample<br /> <a href="http://45.79.161.190:8080/attachments/download/852">icon.png</a> dated 8th July 2024 Version v1<br /> 2. test<br /> <a href="http://45.79.161.190:8080/attachments/download/853">screenshot_from_2024_07_08_11_28_10.png</a> dated 7th July 2024 Version v3</span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study </span></p> <p> <strong>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</strong></p> <p> <strong>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</strong></p> <ol> <li> <p> <strong><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</strong></p> </li> <li> <p> <strong><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</strong></p> </li> <li> <p> <strong><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</strong></p> </li> <li> <p> <strong><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</strong></p> </li> </ol> <p> <strong>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</strong></p> <p> <strong>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</strong></p> <p> <strong>.</strong> <strong>(ECCT/24/06/01).</strong></p> <p>  </p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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      • approvermanager
      • approval_date2024-07-08
      • expiry_date2025-06-21
      • statusamd-1
      • submitted1
      • deleted0
      • deleted_date(null)
      • created2024-07-08 18:55:29
      • modified2024-07-08 18:56:50
    • 2(array)
      • id9
      • application_id77
      • approval_noPPB/ECCT/24/06/01/2024(9)
      • content<h3 style="text-align: center;"> <span style="font-family:bookman old style,serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> <p> <span style="font-family:bookman old style,serif;"><strong>9th July 2024 </strong></span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/06/01 : Amendment Approval; </u></strong></span></p> <p> <strong><u>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</u></strong></p> <p> <strong><u>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</u></strong></p> <ol> <li> <p> <strong><u><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</u></strong></p> </li> <li> <p> <strong><u><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</u></strong></p> </li> </ol> <p> <strong><u>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</u></strong></p> <p> <strong><u>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</u></strong></p> <p> <strong><u>.</u></strong></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. sample<br /> <a href="http://45.79.161.190:8080/attachments/download/852">icon.png</a> dated 8th July 2024 Version v1<br /> 2. test<br /> <a href="http://45.79.161.190:8080/attachments/download/853">screenshot_from_2024_07_08_11_28_10.png</a> dated 7th July 2024 Version v3</span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study </span></p> <p> <strong>Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</strong></p> <p> <strong>Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</strong></p> <ol> <li> <p> <strong><strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</strong></p> </li> <li> <p> <strong><strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</strong></p> </li> <li> <p> <strong><strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</strong></p> </li> <li> <p> <strong><strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</strong></p> </li> </ol> <p> <strong>The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</strong></p> <p> <strong>Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</strong></p> <p> <strong>.</strong> <strong>(ECCT/24/06/01).</strong></p> <p>  </p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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      • created2024-06-11 06:33:24
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      • created2024-06-11 06:33:24
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  • Placebo(array)
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      • placebo_present(null)
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Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@ppb.go.ke</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>Test Patient</patientinitial> <patientgpmedicalrecordnumb></patientgpmedicalrecordnumb> <patientspecialistrecordnumb></patientspecialistrecordnumb> <patienthospitalrecordnumb></patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat/> <patientbirthdate/> <patientonsetage/> <patientonsetageunit/> <gestationperiod/> <gestationperiodunit/> <patientweight></patientweight> <patientheight>0</patientheight> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures></resultstestsprocedures> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction>Nausea nausea</primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt></reactionmeddrallt> <reactionmeddraversionpt></reactionmeddraversionpt> <reactionmeddrapt></reactionmeddrapt> <termhighlighted/> <reactionstartdateformat> 602</reactionstartdateformat> <reactionstartdate><pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4ca64-trace').style.display = (document.getElementById('cakeErr667c0a8c4ca64-trace').style.display == 'none' ? '' : 'none');"><b>Warning</b> (2)</a>: Illegal string offset 'year' [<b>APP/View/Sadrs/xml/download.ctp</b>, line <b>217</b>]<div id="cakeErr667c0a8c4ca64-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4ca64-code').style.display = (document.getElementById('cakeErr667c0a8c4ca64-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4ca64-context').style.display = (document.getElementById('cakeErr667c0a8c4ca64-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr667c0a8c4ca64-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000">                <reactionstartdate><?php</span></code> <code><span style="color: #000000"><span style="color: #0000BB">                    </span><span style="color: #007700">if(</span><span style="color: #0000BB">$onsetf </span><span style="color: #007700">== </span><span style="color: #0000BB">102</span><span style="color: #007700">) echo </span><span style="color: #0000BB">date</span><span style="color: #007700">(</span><span style="color: #DD0000">'Ymd'</span><span style="color: #007700">, </span><span style="color: #0000BB">strtotime</span><span style="color: #007700">(</span><span style="color: #0000BB">implode</span><span style="color: #007700">(</span><span style="color: #DD0000">'-'</span><span style="color: #007700">, </span><span style="color: #0000BB">$sadr</span><span style="color: #007700">[</span><span style="color: #DD0000">'Sadr'</span><span style="color: #007700">][</span><span style="color: #DD0000">'date_of_onset_of_reaction'</span><span style="color: #007700">])));</span></span></code> <span class="code-highlight"><code><span style="color: #000000"><span style="color: #0000BB">                    </span><span style="color: #007700">if(</span><span style="color: #0000BB">$onsetf </span><span style="color: #007700">== </span><span style="color: #0000BB">602</span><span style="color: #007700">) echo </span><span style="color: #0000BB">$sadr</span><span style="color: #007700">[</span><span style="color: #DD0000">'Sadr'</span><span style="color: #007700">][</span><span style="color: #DD0000">'date_of_onset_of_reaction'</span><span style="color: #007700">][</span><span style="color: #DD0000">'year'</span><span style="color: #007700">];</span></span></code></span></pre><pre id="cakeErr667c0a8c4ca64-context" class="cake-context" style="display: none;">$viewFile = '/var/www/pvers/app/View/Sadrs/xml/download.ctp' $dataForView = array( 'debugToolbarPanels' => array( 'history' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'history_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'session' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'session_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'request' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'request_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'sql_log' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'sql_log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'timer' => array( 'content' => null, 'elementName' => 'timer_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'log' => array( 'content' => object(DebugKitLog) {}, 'elementName' => 'log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'variables' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'variables_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'environment' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ), 'debugToolbarJavascript' => array( 'libs' => 'DebugKit./js/js_debug_toolbar' ), 'debugToolbarCss' => array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ), 'sadr' => array( 'Sadr' => array( 'id' => '154', 'sadr_id' => null, 'user_id' => '9263', 'pqmp_id' => null, 'medication_id' => null, 'county_id' => null, 'sub_county_id' => null, 'designation_id' => null, 'reference_no' => 'SADR/2024/122', 'vigiflow_id' => null, 'report_title' => 'Rash', 'report_type' => 'Initial', 'report_sadr' => null, 'report_therapeutic' => null, 'report_misuse' => null, 'report_off_label' => null, 'product_category' => null, 'medicinal_product' => null, 'blood_products' => null, 'herbal_product' => null, 'cosmeceuticals' => null, 'product_other' => null, 'product_specify' => null, 'name_of_institution' => null, 'institution_code' => null, 'address' => null, 'contact' => null, 'patient_name' => 'Test Patient', 'ip_no' => null, 'date_of_birth' => '', 'age_group' => '', 'patient_address' => null, 'ward' => null, 'gender' => 'Male', 'known_allergy' => null, 'known_allergy_specify' => null, 'pregnant' => null, 'pregnancy_status' => '', 'weight' => null, 'height' => null, 'diagnosis' => null, 'reaction' => 'Nausea nausea', 'medical_history' => null, 'date_of_onset_of_reaction' => '', 'description_of_reaction' => 'Some Test Reaction', 'reaction_resolve' => null, 'reaction_reappear' => null, 'lab_investigation' => null, 'severity' => null, 'serious' => 'Yes', 'serious_reason' => null, 'action_taken' => 'Drug Withdrawn', 'outcome' => 'Unknown', 'causality' => null, 'any_other_comment' => null, 'reporter_name' => 'Test Reporter', 'reporter_email' => 'jkiprotich@intellisoftkenya.com', 'reporter_phone' => null, 'submitted' => '2', 'emails' => '0', 'active' => '1', 'device' => '0', 'deleted' => false, 'archived' => false, 'archived_date' => null, 'deleted_date' => null, 'notified' => '0', 'created' => '2024-06-06 22:23:39', 'modified' => '2024-06-06 22:23:39', 'reporter_date' => '06-06-2024', 'person_submitting' => null, 'reporter_name_diff' => null, 'reporter_designation_diff' => null, 'reporter_email_diff' => null, 'reporter_phone_diff' => null, 'reporter_date_diff' => null, 'assigned_to' => null, 'assigned_by' => null, 'assigned_date' => null, 'vigiflow_message' => null, 'vigiflow_ref' => null, 'vigiflow_date' => null, 'webradr_ref' => null, 'webradr_date' => null, 'submitted_date' => '2024-06-06 22:23:39', 'webradr_message' => null, 'copied' => '0', 'medra' => null ), 'County' => array( 'id' => null, 'county_name' => null, 'org_unit' => null, 'created' => null, 'modified' => null ), 'SubCounty' => array( 'id' => null, 'county_id' => null, 'sub_county_name' => null, 'county_name' => null, 'Province' => null, 'Pop_2009' => null, 'RegVoters' => null, 'AreaSqKms' => null, 'CAWards' => null, 'MainEthnicGroup' => null, 'created' => null, 'modified' => null ), 'Designation' => array( 'id' => null, 'name' => null, 'category' => null, 'created' => null, 'modified' => null ), 'SadrListOfDrug' => array(), 'SadrDescription' => array(), 'Attachment' => array() ), 'root' => '/', 'redir' => 'manager' ) $debugToolbarPanels = array( 'history' => array( 'content' => array( (int) 0 => array( [maximum depth reached] ), (int) 1 => array( [maximum depth reached] ), (int) 2 => array( [maximum depth reached] ), (int) 3 => array( [maximum depth reached] ) ), 'elementName' => 'history_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'session' => array( 'content' => array( 'Config' => array( [maximum depth reached] ), 'Auth' => array( [maximum depth reached] ) ), 'elementName' => 'session_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'request' => array( 'content' => array( 'params' => array( [maximum depth reached] ), 'url' => 'sadrs/download/154.xml', 'query' => array([maximum depth reached]), 'data' => array([maximum depth reached]), 'get' => array([maximum depth reached]), 'currentRoute' => object(CakeRoute) {} ), 'elementName' => 'request_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'sql_log' => array( 'content' => array( 'connections' => array( [maximum depth reached] ), 'threshold' => (int) 20 ), 'elementName' => 'sql_log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'timer' => array( 'content' => null, 'elementName' => 'timer_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'log' => array( 'content' => object(DebugKitLog) {}, 'elementName' => 'log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'variables' => array( 'content' => array( 'sadr' => array( [maximum depth reached] ), 'root' => '/', 'redir' => 'manager', '$request->data' => array([maximum depth reached]) ), 'elementName' => 'variables_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'environment' => array( 'content' => array( 'php' => array( [maximum depth reached] ), 'cake' => array( [maximum depth reached] ), 'app' => array( [maximum depth reached] ) ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( 'core' => array( [maximum depth reached] ), 'app' => array( [maximum depth reached] ), 'plugins' => array( [maximum depth reached] ), 'paths' => array( [maximum depth reached] ) ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ) $debugToolbarJavascript = array( 'libs' => 'DebugKit./js/js_debug_toolbar' ) $debugToolbarCss = array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ) $sadr = array( 'Sadr' => array( 'id' => '154', 'sadr_id' => null, 'user_id' => '9263', 'pqmp_id' => null, 'medication_id' => null, 'county_id' => null, 'sub_county_id' => null, 'designation_id' => null, 'reference_no' => 'SADR/2024/122', 'vigiflow_id' => null, 'report_title' => 'Rash', 'report_type' => 'Initial', 'report_sadr' => null, 'report_therapeutic' => null, 'report_misuse' => null, 'report_off_label' => null, 'product_category' => null, 'medicinal_product' => null, 'blood_products' => null, 'herbal_product' => null, 'cosmeceuticals' => null, 'product_other' => null, 'product_specify' => null, 'name_of_institution' => null, 'institution_code' => null, 'address' => null, 'contact' => null, 'patient_name' => 'Test Patient', 'ip_no' => null, 'date_of_birth' => '', 'age_group' => '', 'patient_address' => null, 'ward' => null, 'gender' => 'Male', 'known_allergy' => null, 'known_allergy_specify' => null, 'pregnant' => null, 'pregnancy_status' => '', 'weight' => null, 'height' => null, 'diagnosis' => null, 'reaction' => 'Nausea nausea', 'medical_history' => null, 'date_of_onset_of_reaction' => '', 'description_of_reaction' => 'Some Test Reaction', 'reaction_resolve' => null, 'reaction_reappear' => null, 'lab_investigation' => null, 'severity' => null, 'serious' => 'Yes', 'serious_reason' => null, 'action_taken' => 'Drug Withdrawn', 'outcome' => 'Unknown', 'causality' => null, 'any_other_comment' => null, 'reporter_name' => 'Test Reporter', 'reporter_email' => 'jkiprotich@intellisoftkenya.com', 'reporter_phone' => null, 'submitted' => '2', 'emails' => '0', 'active' => '1', 'device' => '0', 'deleted' => false, 'archived' => false, 'archived_date' => null, 'deleted_date' => null, 'notified' => '0', 'created' => '2024-06-06 22:23:39', 'modified' => '2024-06-06 22:23:39', 'reporter_date' => '06-06-2024', 'person_submitting' => null, 'reporter_name_diff' => null, 'reporter_designation_diff' => null, 'reporter_email_diff' => null, 'reporter_phone_diff' => null, 'reporter_date_diff' => null, 'assigned_to' => null, 'assigned_by' => null, 'assigned_date' => null, 'vigiflow_message' => null, 'vigiflow_ref' => null, 'vigiflow_date' => null, 'webradr_ref' => null, 'webradr_date' => null, 'submitted_date' => '2024-06-06 22:23:39', 'webradr_message' => null, 'copied' => '0', 'medra' => null ), 'County' => array( 'id' => null, 'county_name' => null, 'org_unit' => null, 'created' => null, 'modified' => null ), 'SubCounty' => array( 'id' => null, 'county_id' => null, 'sub_county_name' => null, 'county_name' => null, 'Province' => null, 'Pop_2009' => null, 'RegVoters' => null, 'AreaSqKms' => null, 'CAWards' => null, 'MainEthnicGroup' => null, 'created' => null, 'modified' => null ), 'Designation' => array( 'id' => null, 'name' => null, 'category' => null, 'created' => null, 'modified' => null ), 'SadrListOfDrug' => array(), 'SadrDescription' => array(), 'Attachment' => array() ) $root = '/' $redir = 'manager' $arr = array( (int) 0 => 'Test', (int) 1 => 'Reporter' ) $ages = array( 'neonate' => (int) 1, 'infant' => (int) 2, 'child' => (int) 3, 'adolescent' => (int) 4, 'adult' => (int) 5, 'elderly' => (int) 6 ) $onsetf = (int) 602</pre><pre class="stack-trace">include - APP/View/Sadrs/xml/download.ctp, line 217 View::_evaluate() - CORE/Cake/View/View.php, line 971 View::_render() - CORE/Cake/View/View.php, line 933 View::render() - CORE/Cake/View/View.php, line 473 XmlView::render() - CORE/Cake/View/XmlView.php, line 105 Controller::render() - CORE/Cake/Controller/Controller.php, line 968 Dispatcher::_invoke() - CORE/Cake/Routing/Dispatcher.php, line 200 Dispatcher::dispatch() - CORE/Cake/Routing/Dispatcher.php, line 167 [main] - APP/webroot/index.php, line 118</pre></div></pre><pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4d87b-trace').style.display = (document.getElementById('cakeErr667c0a8c4d87b-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Uninitialized string offset: 0 [<b>APP/View/Sadrs/xml/download.ctp</b>, line <b>217</b>]<div id="cakeErr667c0a8c4d87b-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4d87b-code').style.display = (document.getElementById('cakeErr667c0a8c4d87b-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr667c0a8c4d87b-context').style.display = (document.getElementById('cakeErr667c0a8c4d87b-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr667c0a8c4d87b-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000">                <reactionstartdate><?php</span></code> <code><span style="color: #000000"><span style="color: #0000BB">                    </span><span style="color: #007700">if(</span><span style="color: #0000BB">$onsetf </span><span style="color: #007700">== </span><span style="color: #0000BB">102</span><span style="color: #007700">) echo </span><span style="color: #0000BB">date</span><span style="color: #007700">(</span><span style="color: #DD0000">'Ymd'</span><span style="color: #007700">, </span><span style="color: #0000BB">strtotime</span><span style="color: #007700">(</span><span style="color: #0000BB">implode</span><span style="color: #007700">(</span><span style="color: #DD0000">'-'</span><span style="color: #007700">, </span><span style="color: #0000BB">$sadr</span><span style="color: #007700">[</span><span style="color: #DD0000">'Sadr'</span><span style="color: #007700">][</span><span style="color: #DD0000">'date_of_onset_of_reaction'</span><span style="color: #007700">])));</span></span></code> <span class="code-highlight"><code><span style="color: #000000"><span style="color: #0000BB">                    </span><span style="color: #007700">if(</span><span style="color: #0000BB">$onsetf </span><span style="color: #007700">== </span><span style="color: #0000BB">602</span><span style="color: #007700">) echo </span><span style="color: #0000BB">$sadr</span><span style="color: #007700">[</span><span style="color: #DD0000">'Sadr'</span><span style="color: #007700">][</span><span style="color: #DD0000">'date_of_onset_of_reaction'</span><span style="color: #007700">][</span><span style="color: #DD0000">'year'</span><span style="color: #007700">];</span></span></code></span></pre><pre id="cakeErr667c0a8c4d87b-context" class="cake-context" style="display: none;">$viewFile = '/var/www/pvers/app/View/Sadrs/xml/download.ctp' $dataForView = array( 'debugToolbarPanels' => array( 'history' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'history_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'session' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'session_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'request' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'request_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'sql_log' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'sql_log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'timer' => array( 'content' => null, 'elementName' => 'timer_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'log' => array( 'content' => object(DebugKitLog) {}, 'elementName' => 'log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'variables' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'variables_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'environment' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ), 'debugToolbarJavascript' => array( 'libs' => 'DebugKit./js/js_debug_toolbar' ), 'debugToolbarCss' => array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ), 'sadr' => array( 'Sadr' => array( 'id' => '154', 'sadr_id' => null, 'user_id' => '9263', 'pqmp_id' => null, 'medication_id' => null, 'county_id' => null, 'sub_county_id' => null, 'designation_id' => null, 'reference_no' => 'SADR/2024/122', 'vigiflow_id' => null, 'report_title' => 'Rash', 'report_type' => 'Initial', 'report_sadr' => null, 'report_therapeutic' => null, 'report_misuse' => null, 'report_off_label' => null, 'product_category' => null, 'medicinal_product' => null, 'blood_products' => null, 'herbal_product' => null, 'cosmeceuticals' => null, 'product_other' => null, 'product_specify' => null, 'name_of_institution' => null, 'institution_code' => null, 'address' => null, 'contact' => null, 'patient_name' => 'Test Patient', 'ip_no' => null, 'date_of_birth' => '', 'age_group' => '', 'patient_address' => null, 'ward' => null, 'gender' => 'Male', 'known_allergy' => null, 'known_allergy_specify' => null, 'pregnant' => null, 'pregnancy_status' => '', 'weight' => null, 'height' => null, 'diagnosis' => null, 'reaction' => 'Nausea nausea', 'medical_history' => null, 'date_of_onset_of_reaction' => '', 'description_of_reaction' => 'Some Test Reaction', 'reaction_resolve' => null, 'reaction_reappear' => null, 'lab_investigation' => null, 'severity' => null, 'serious' => 'Yes', 'serious_reason' => null, 'action_taken' => 'Drug Withdrawn', 'outcome' => 'Unknown', 'causality' => null, 'any_other_comment' => null, 'reporter_name' => 'Test Reporter', 'reporter_email' => 'jkiprotich@intellisoftkenya.com', 'reporter_phone' => null, 'submitted' => '2', 'emails' => '0', 'active' => '1', 'device' => '0', 'deleted' => false, 'archived' => false, 'archived_date' => null, 'deleted_date' => null, 'notified' => '0', 'created' => '2024-06-06 22:23:39', 'modified' => '2024-06-06 22:23:39', 'reporter_date' => '06-06-2024', 'person_submitting' => null, 'reporter_name_diff' => null, 'reporter_designation_diff' => null, 'reporter_email_diff' => null, 'reporter_phone_diff' => null, 'reporter_date_diff' => null, 'assigned_to' => null, 'assigned_by' => null, 'assigned_date' => null, 'vigiflow_message' => null, 'vigiflow_ref' => null, 'vigiflow_date' => null, 'webradr_ref' => null, 'webradr_date' => null, 'submitted_date' => '2024-06-06 22:23:39', 'webradr_message' => null, 'copied' => '0', 'medra' => null ), 'County' => array( 'id' => null, 'county_name' => null, 'org_unit' => null, 'created' => null, 'modified' => null ), 'SubCounty' => array( 'id' => null, 'county_id' => null, 'sub_county_name' => null, 'county_name' => null, 'Province' => null, 'Pop_2009' => null, 'RegVoters' => null, 'AreaSqKms' => null, 'CAWards' => null, 'MainEthnicGroup' => null, 'created' => null, 'modified' => null ), 'Designation' => array( 'id' => null, 'name' => null, 'category' => null, 'created' => null, 'modified' => null ), 'SadrListOfDrug' => array(), 'SadrDescription' => array(), 'Attachment' => array() ), 'root' => '/', 'redir' => 'manager' ) $debugToolbarPanels = array( 'history' => array( 'content' => array( (int) 0 => array( [maximum depth reached] ), (int) 1 => array( [maximum depth reached] ), (int) 2 => array( [maximum depth reached] ), (int) 3 => array( [maximum depth reached] ) ), 'elementName' => 'history_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'session' => array( 'content' => array( 'Config' => array( [maximum depth reached] ), 'Auth' => array( [maximum depth reached] ) ), 'elementName' => 'session_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'request' => array( 'content' => array( 'params' => array( [maximum depth reached] ), 'url' => 'sadrs/download/154.xml', 'query' => array([maximum depth reached]), 'data' => array([maximum depth reached]), 'get' => array([maximum depth reached]), 'currentRoute' => object(CakeRoute) {} ), 'elementName' => 'request_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'sql_log' => array( 'content' => array( 'connections' => array( [maximum depth reached] ), 'threshold' => (int) 20 ), 'elementName' => 'sql_log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'timer' => array( 'content' => null, 'elementName' => 'timer_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'log' => array( 'content' => object(DebugKitLog) {}, 'elementName' => 'log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'variables' => array( 'content' => array( 'sadr' => array( [maximum depth reached] ), 'root' => '/', 'redir' => 'manager', '$request->data' => array([maximum depth reached]) ), 'elementName' => 'variables_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'environment' => array( 'content' => array( 'php' => array( [maximum depth reached] ), 'cake' => array( [maximum depth reached] ), 'app' => array( [maximum depth reached] ) ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( 'core' => array( [maximum depth reached] ), 'app' => array( [maximum depth reached] ), 'plugins' => array( [maximum depth reached] ), 'paths' => array( [maximum depth reached] ) ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ) $debugToolbarJavascript = array( 'libs' => 'DebugKit./js/js_debug_toolbar' ) $debugToolbarCss = array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ) $sadr = array( 'Sadr' => array( 'id' => '154', 'sadr_id' => null, 'user_id' => '9263', 'pqmp_id' => null, 'medication_id' => null, 'county_id' => null, 'sub_county_id' => null, 'designation_id' => null, 'reference_no' => 'SADR/2024/122', 'vigiflow_id' => null, 'report_title' => 'Rash', 'report_type' => 'Initial', 'report_sadr' => null, 'report_therapeutic' => null, 'report_misuse' => null, 'report_off_label' => null, 'product_category' => null, 'medicinal_product' => null, 'blood_products' => null, 'herbal_product' => null, 'cosmeceuticals' => null, 'product_other' => null, 'product_specify' => null, 'name_of_institution' => null, 'institution_code' => null, 'address' => null, 'contact' => null, 'patient_name' => 'Test Patient', 'ip_no' => null, 'date_of_birth' => '', 'age_group' => '', 'patient_address' => null, 'ward' => null, 'gender' => 'Male', 'known_allergy' => null, 'known_allergy_specify' => null, 'pregnant' => null, 'pregnancy_status' => '', 'weight' => null, 'height' => null, 'diagnosis' => null, 'reaction' => 'Nausea nausea', 'medical_history' => null, 'date_of_onset_of_reaction' => '', 'description_of_reaction' => 'Some Test Reaction', 'reaction_resolve' => null, 'reaction_reappear' => null, 'lab_investigation' => null, 'severity' => null, 'serious' => 'Yes', 'serious_reason' => null, 'action_taken' => 'Drug Withdrawn', 'outcome' => 'Unknown', 'causality' => null, 'any_other_comment' => null, 'reporter_name' => 'Test Reporter', 'reporter_email' => 'jkiprotich@intellisoftkenya.com', 'reporter_phone' => null, 'submitted' => '2', 'emails' => '0', 'active' => '1', 'device' => '0', 'deleted' => false, 'archived' => false, 'archived_date' => null, 'deleted_date' => null, 'notified' => '0', 'created' => '2024-06-06 22:23:39', 'modified' => '2024-06-06 22:23:39', 'reporter_date' => '06-06-2024', 'person_submitting' => null, 'reporter_name_diff' => null, 'reporter_designation_diff' => null, 'reporter_email_diff' => null, 'reporter_phone_diff' => null, 'reporter_date_diff' => null, 'assigned_to' => null, 'assigned_by' => null, 'assigned_date' => null, 'vigiflow_message' => null, 'vigiflow_ref' => null, 'vigiflow_date' => null, 'webradr_ref' => null, 'webradr_date' => null, 'submitted_date' => '2024-06-06 22:23:39', 'webradr_message' => null, 'copied' => '0', 'medra' => null ), 'County' => array( 'id' => null, 'county_name' => null, 'org_unit' => null, 'created' => null, 'modified' => null ), 'SubCounty' => array( 'id' => null, 'county_id' => null, 'sub_county_name' => null, 'county_name' => null, 'Province' => null, 'Pop_2009' => null, 'RegVoters' => null, 'AreaSqKms' => null, 'CAWards' => null, 'MainEthnicGroup' => null, 'created' => null, 'modified' => null ), 'Designation' => array( 'id' => null, 'name' => null, 'category' => null, 'created' => null, 'modified' => null ), 'SadrListOfDrug' => array(), 'SadrDescription' => array(), 'Attachment' => array() ) $root = '/' $redir = 'manager' $arr = array( (int) 0 => 'Test', (int) 1 => 'Reporter' ) $ages = array( 'neonate' => (int) 1, 'infant' => (int) 2, 'child' => (int) 3, 'adolescent' => (int) 4, 'adult' => (int) 5, 'elderly' => (int) 6 ) $onsetf = (int) 602</pre><pre class="stack-trace">include - APP/View/Sadrs/xml/download.ctp, line 217 View::_evaluate() - CORE/Cake/View/View.php, line 971 View::_render() - CORE/Cake/View/View.php, line 933 View::render() - CORE/Cake/View/View.php, line 473 XmlView::render() - CORE/Cake/View/XmlView.php, line 105 Controller::render() - CORE/Cake/Controller/Controller.php, line 968 Dispatcher::_invoke() - CORE/Cake/Routing/Dispatcher.php, line 200 Dispatcher::dispatch() - CORE/Cake/Routing/Dispatcher.php, line 167 [main] - APP/webroot/index.php, line 118</pre></div></pre></reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>6</reactionoutcome> </reaction> <summary> <narrativeincludeclinical>Some Test Reaction</narrativeincludeclinical> <reportercomment></reportercomment> <senderdiagnosismeddraversion /> <senderdiagnosis /> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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      • e2b_content<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2023-11968</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20230918122155</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-AEFI/2023/5304</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>2</serious> <seriousnessdeath>0</seriousnessdeath> <seriousnesslifethreatening>0</seriousnesslifethreatening> <seriousnesshospitalization>0</seriousnesshospitalization> <seriousnessdisabling>0</seriousnessdisabling> <seriousnesscongenitalanomali>0</seriousnesscongenitalanomali> <seriousnessother>0</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20230719</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20230719</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>2</fulfillexpeditecriteria> <authoritynumb>KE-PPB-AEFI/2023/5304</authoritynumb> <companynumb/> <duplicate/> <casenullification/> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Betty</reportergivename> <reporterfamilyname>Munanie Mulwa</reporterfamilyname> <reporterorganization>Kitengela Health Centre</reporterorganization> <reporterdepartment/> <reporterstreet/> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>3</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>T.K</patientinitial> <patientgpmedicalrecordnumb>KSCH1657</patientgpmedicalrecordnumb> <patientspecialistrecordnumb>KSCH1657</patientspecialistrecordnumb> <patienthospitalrecordnumb>KSCH1657</patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat>102</patientbirthdateformat> <patientbirthdate>19960828</patientbirthdate> <patientonsetage/><patientonsetageunit/> <gestationperiod/> <gestationperiodunit/> <patientagegroup/> <patientweight/> <patientheight/> <patientsex>2</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures/> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction> </primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>Pain at the injection site and headache </reactionmeddrallt> <reactionmeddraversionpt/> <reactionmeddrapt/> <termhighlighted/> <reactionstartdateformat>102</reactionstartdateformat><reactionstartdate>20230710</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>2</reactionoutcome> </reaction> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct> COVID-19 Vaccine - (JOHNSON&JOHNSONS)JANSSEN</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb>ACB6959</drugbatchnumb> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>1</drugstructuredosagenumb> <drugstructuredosageunit/> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext>1</drugdosagetext> <drugdosageform/> <drugadministrationroute/> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication/> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20230710</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat/> <drugenddate/> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug/> <drugrecurreadministration/> <drugadditional></drugadditional> <activesubstance> <activesubstancename></activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion>23.0</drugreactionassesmeddraversion> <drugreactionasses>Pain at the injection site and headache </drugreactionasses> <drugassessmentsource/> <drugassessmentmethod/> <drugresult/> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>The participant experienced Pain at the injection site and headache 7 Hours after vaccination </narrativeincludeclinical> <reportercomment/> <senderdiagnosismeddraversion>23.0</senderdiagnosismeddraversion> <senderdiagnosis></senderdiagnosis> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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      • addressDeserunt nisi sed autem voluptatem nemo odio mollit iste incidunt sit nostrum ipsum asperiores sequi aut aliquam
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    • 18(array)
      • id721
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_10.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_10.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_indemnity_pi
      • version_no1
      • created2024-06-11 06:41:03
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_10.xml
    • 19(array)
      • id722
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_11.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_11.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_indemnity_cover
      • version_no1
      • created2024-06-11 06:41:15
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_11.xml
    • 20(array)
      • id723
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/sadr_1_10.xml
      • foreign_key77
      • dirnamegen
      • basenamesadr_1_10.xml
      • checksum8585cc74969ad92a7b137988fb156b90
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_opinion_letter
      • version_no1
      • created2024-06-11 06:41:25
      • modified2024-06-11 06:48:58
      • pathgen/sadr_1_10.xml
    • 21(array)
      • id724
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_12.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_12.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_practice_license
      • descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_practice_license
      • version_no1
      • created2024-06-11 06:41:38
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_12.xml
    • 22(array)
      • id725
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/sadr_1_11.xml
      • foreign_key77
      • dirnamegen
      • basenamesadr_1_11.xml
      • checksum8585cc74969ad92a7b137988fb156b90
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_approval_letter
      • version_no1
      • created2024-06-11 06:41:51
      • modified2024-06-11 06:48:58
      • pathgen/sadr_1_11.xml
    • 23(array)
      • id726
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_13.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_13.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_addendum
      • descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc
      • year(null)
      • file_date10-06-2024
      • pocket_nameapplicant_addendum
      • version_no1
      • created2024-06-11 06:42:03
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_13.xml
    • 24(array)
      • id727
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_14.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_14.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_statement
      • descriptionA signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. *
      • year(null)
      • file_date10-06-2024
      • pocket_nameapplicant_statement
      • version_no1
      • created2024-06-11 06:42:14
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_14.xml
    • 25(array)
      • id728
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_15.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_15.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_fees
      • version_no1
      • created2024-06-11 06:42:27
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_15.xml
    • 26(array)
      • id729
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_16.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_16.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date11-06-2024
      • pocket_namestatistical_analysis_plan
      • version_no1
      • created2024-06-11 06:42:38
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_16.xml
    • 27(array)
      • id730
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/gen/aefi_r3_1666_17.xml
      • foreign_key77
      • dirnamegen
      • basenameaefi_r3_1666_17.xml
      • checksum0265a595f177018ae388de27925f73ed
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_signed_checklist
      • version_no1
      • created2024-06-11 06:42:47
      • modified2024-06-11 06:48:58
      • pathgen/aefi_r3_1666_17.xml
  • StudyMonitor(empty)
  • ProtocolOutsource(array)
    • 0(array)
      • id2
      • user_id77
      • application_id98
      • outsource_id3
      • owner_id26
      • created2024-06-25 09:00:02
      • modified2024-06-25 09:00:02
  • Outsource(empty)
• redir
• $request->data(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • Review(empty)
  • ActiveInspector(empty)
  • ManagerReview(empty)
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(empty)
  • ApplicationStage(empty)
  • Pharmacist(empty)
  • EthicalCommittee(empty)
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(empty)
  • SiteDetail(empty)
  • Placebo(empty)
  • Sponsor(empty)
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(empty)
  • Manufacturer(empty)
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(empty)
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(empty)
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6DebugTimer
  • 7Toolbar
  • 8HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/ctr/lib
• 3/usr/share/php
• 4-> /var/www/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
    • 1APP/Model/Behavior/TimestampBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/Review.php
    • 5APP/Model/ActiveInspector.php
    • 6APP/Model/Amendment.php
    • 7APP/Model/InvestigatorContact.php
    • 8APP/Model/ApplicationStage.php
    • 9APP/Model/Pharmacist.php
    • 10APP/Model/EthicalCommittee.php
    • 11APP/Model/AnnualLetter.php
    • 12APP/Model/AmendmentLetter.php
    • 13APP/Model/AmendmentApproval.php
    • 14APP/Model/Organization.php
    • 15APP/Model/SiteDetail.php
    • 16APP/Model/Placebo.php
    • 17APP/Model/Sponsor.php
    • 18APP/Model/SiteInspection.php
    • 19APP/Model/Sae.php
    • 20APP/Model/Ciom.php
    • 21APP/Model/StudyRoute.php
    • 22APP/Model/Manufacturer.php
    • 23APP/Model/Reassignment.php
    • 24APP/Model/Attachment.php
    • 25APP/Model/Reminder.php
    • 26APP/Model/ParticipantFlow.php
    • 27APP/Model/Budget.php
    • 28APP/Model/Deviation.php
    • 29APP/Model/StudyMonitor.php
    • 30APP/Model/ProtocolOutsource.php
    • 31APP/Model/Outsource.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
    • Behavior(array)
      • 0Media/Model/Behavior/TransferBehavior.php
      • 1Media/Model/Behavior/CouplerBehavior.php
      • 2Media/Model/Behavior/MetaBehavior.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php