GCP Guidance Policies and Templates
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
2. GCP Training
3. Responsibilities of the Research Team
Regulatory Binder Table of Contents Template
11. Study Completion Activities
13. Consent Process
14. Consent Document
Subject Screening and Enrollment Log
17. Unanticipated Problems Involving Risks to Subjects or Others
19. Source Documents
20. Study Closure
21. Glossary
Other Resources:
External Links:
OFFICE OF RESEARCH | CLINICAL TRIALS RESOURCE CENTER |
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS |ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS | TECHNOLOGY MANAGEMENT
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Clinical Trials Resource Center (CTRC) last modified March 21, 2013 |
