Research and Regulatory Tools & Resources

As per the International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline 4.9.4, a key responsibility of an investigator is to maintain certain trial-related documents so that it is possible to evaluate the ethical and procedural conduct of a trial and the quality of the data produced. These “Essential Documents,” including both participant-specific documents and study-related documents are specified in section 8 of the ICH GCP Guideline.

These customizable study management tools intend to help you manage regulatory and participant documentation for your study.

Participant Files Research Subject Eligibility Assessment Form: Helps you document individual research subject eligibility assessments.
Templates that will help you manage participant documentation for your research study. Documentation of Informed Consent Tool: Tool that will guide you through documenting the informed consent process.

Documentation of Pregnancy Testing: This tool will help you document pregnancy testing or the determination that pregnancy testing is not required.

Note-to-File Template

Regulatory Files Regulatory Binder Tabs: A set of 15 tabs to help set up your Regulatory Binder
Templates that will help you manage regulatory documentation for your research study. Regulatory Binder Tab Inserts: A list of customizable templates of logs used for regulatory record-keeping.

FAQs on Regulatory Documentation: Frequently Asked Questions

Self-Assessment Review Tools

Easy-to-use checklists can help you assess your study documentation and conduct in multiple areas: consenting, inclusion/exclusion criteria, and protocol adherence.

Self-Assessment Review Checklist

Consent Documentation and Process Assessment

Inclusion/Exclusion Criteria Adherence Assessment

Protocol Adherence Assessment