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 email@example.com.
2. GCP Training
3. Responsibilities of the Research Team
FDA Inspection Checklist
FDA Inspection Information
13. Consent Process
14. Consent Document
19. Source Documents
20. Study Closure
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