Pharmacy and Poisons Board
Protocol No: ECCT/24/01/03 Date of Protocol: 11-01-2024
Study Title:

The introduction should open with remarks stating that this document is a research registry protocol. The registry that will be conducted in compliance with the protocol, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines (E6) for GCPs standards as adopted by the Food and Drug Administration (FDA), and associated Federal regulations, and all applicable institutional research requirements. The rest of the introduction is broken out into subsections. Example language for the first paragraph under “Introduction” is given below.

 

If you state you are following GCP or other regulations, please be sure that you are familiar with these as the conduct of your research registry will be reviewed against these standards (www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf).

 

Sample Text: This document is a protocol for a human research registry. This registry is to be conducted according to US standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

 
Study Objectives:

The introduction should open with remarks stating that this document is a research registry protocol. The registry that will be conducted in compliance with the protocol, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines (E6) for GCPs standards as adopted by the Food and Drug Administration (FDA), and associated Federal regulations, and all applicable institutional research requirements. The rest of the introduction is broken out into subsections. Example language for the first paragraph under “Introduction” is given below.

 

If you state you are following GCP or other regulations, please be sure that you are familiar with these as the conduct of your research registry will be reviewed against these standards (www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf).

 

Sample Text: This document is a protocol for a human research registry. This registry is to be conducted according to US standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

 
Laymans Summary:

The introduction should open with remarks stating that this document is a research registry protocol. The registry that will be conducted in compliance with the protocol, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines (E6) for GCPs standards as adopted by the Food and Drug Administration (FDA), and associated Federal regulations, and all applicable institutional research requirements. The rest of the introduction is broken out into subsections. Example language for the first paragraph under “Introduction” is given below.

 

If you state you are following GCP or other regulations, please be sure that you are familiar with these as the conduct of your research registry will be reviewed against these standards (www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf).

 

Sample Text: This document is a protocol for a human research registry. This registry is to be conducted according to US standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

 
Abstract of Study:

The introduction should open with remarks stating that this document is a research registry protocol. The registry that will be conducted in compliance with the protocol, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines (E6) for GCPs standards as adopted by the Food and Drug Administration (FDA), and associated Federal regulations, and all applicable institutional research requirements. The rest of the introduction is broken out into subsections. Example language for the first paragraph under “Introduction” is given below.

 

If you state you are following GCP or other regulations, please be sure that you are familiar with these as the conduct of your research registry will be reviewed against these standards (www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf).

 

Sample Text: This document is a protocol for a human research registry. This registry is to be conducted according to US standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.