To assist with implementation of GCP standards and documentation requirements (often referred to as the "Regulatory Binder"), please refer to the following toolkit with a collection of guidance, checklists, and resources.

• UTA GCP Toolkit - Essential Documents and the Regulatory Binder

This document lists all the required GCP documents, an explanation of the purpose for each, and links/guidance to templates and examples.

• UTA Checklists (3) of Essential GCP Documents (#1 Pre-Study, #2 During Study, #3 Post-Study) 

These checklists convert all the required documents into 3 checklists to use before, during, and after the study. The checklists can be used to note the format of each record, where it's located/stored, and who in the lab is responsible for maintaining it. It is recommended to fill out the Checklist(s) and store it in the Regulatory Binder.

• Additional Resources:
  • NIH Regulatory Binder Template with Printable Binder Tabs/Divider Sheets
  • NIH Toolkit for Clinical Researchers
  • NIH Clinical Research Toolbox
  • NIH Template for Manual of Procedures for a lab/study
  • NIH Template for Standard Operating Procedures for a lab/study
  • World Health Organization Handbook for Good Clinical Practice
  • Sample "Note to File" form
  • Article, Writing Notes to File at the Study Site
  • Guidelines for Writing Notes to the Study File
  • Notes to File
  • FAQs on the NIH Policy on Good Clinical Practice (GCP) Training for NIH Awardees Involved in NIH-funded Clinical Trials

GCP Training

For IRB protocols meeting the types of studies in the GCP Applicability section above, research team members are required to complete GCP training prior to approval of the protocol.