Clinical Trials Resource Center

GCP Guidance Policies and Templates

policies

Over the last couple of years, a group of experienced regulatory specialists and senior research coordinators developed GCP guidance documents. 

Each of these guidance documents includes a research tools that will assist in conduct of clinical research according to GCP guidelines. For example, the guidance on Site Initiation includes a template for the Table of Contents for a Regulatory Binder, Study Responsibility Delegation Log etc.

You may choose to use these guidance documents as templates and develop Standard Operating Procedures specific to your site.

Before you use the tools, remember to enter the protocol title and other study specific information.

Below are links to guidance documents that have been developed (in bold). Documents names without links (not bold) are in the development process and we will upload them to this page as soon as they are ready.

For questions, comments and suggestions please contact us at clinicaltrials@uth.tmc.edu.

1. Writing GCP Guidance Documents

       SOP Template

 

2.  GCP Training

        Training Log

 

3.  Responsibilities of the  Research Team

        Study Responsibility Log

 

4.  Feasibility Assessment

        Feasibility Questionnaire

 

5.  Study Initiation

        Regulatory Binder Table of Contents Template

        Study Responsibility Log

 

6.  Communicating with CPHS

        CPHS Communication Log

 

7.  Records Retention

 

8.  Drug Accountability

        Drug Accountability Log

 

9.  Device Accountability

        Device Accountability Log

 

10. Quality Management Plan

        Chart Review Checklist

        Monitoring Checklist

 

11. Study Completion Activities

        Study Closure Checklist

 

12. Preparing for Inspections

        FDA Inspection Checklist

        FDA Inspection Reporting

        FDA Inspection Information

 

13. Consent Process

 

14. Consent Document

        Consent Template

        Consent Elements

        Consent Document LAR

 

15. Subject Recruitment

        Flyer Template

        Subject Screening and  Enrollment Log

        Subject Visit Schedule Log

        Subject Contact List

 

16. Specimen Collection

        Specimen Log

 

17. Unanticipated Problems Involving Risks to Subjects or Others

        UP Tracking Log

 

18. Protocol Deviation

        Protocol Deviation Log

 

19. Source Documents

        Study Worksheet / Flowsheet

 

20. Study Closure

        Study Closure Checklist

 

21.   Glossary                  


Other Resources:

CPHS Policies

IND/IDE Policies

Quality Management Plans

External Links:

FDA Regulations

ICH GCP Guidelines