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Study Documentation Tools

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 trial-related documents which permit evaluation of the conduct of a trial and the quality of the data produced.  These “Essential Documents,” include both participant-specific documents and regulatory and protocol-related documents, and are specified in ICH GCP Guideline section 8.0.

The customizable tools provided here are optional, but these (or similar) tools are highly recommended to assist study teams in meeting protocol and regulatory standards to ensure valid and reliable data. 

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
Tools that will help you manage  regulatory documentation for your research study. FAQs on Regulatory Documentation
Regulatory Binder Tabs
REDCap e-Reg Lite (NEW)
AdobeSign Guidance (NEW)

Customizable templates for you to use as needed:
Communications Log
Deviation/Exception Submission Log 
Deviation Log-COVID 19 Disruption
DSMP Template
Essential Documents Location Log
Internal AE/UP Report Tracking Log (MS Word)
Internal AE/UP Report Tracking Log (MS Excel)
IRB Submission Tracking Log
Participant Identification Log
Phone Call Summary Report
Safety Report Tracking Log (MS Word)
Safety Report Tracking Log (MS Excel)
Screening/Enrollment Log
Site Visit Log
SOP Template
Staff License/Certification Log
Staff Member Training Log
Staff Training Log for Groups
Stored Biosample Log
Study Identification
Study Participant Withdrawal/Termination Log
Study-Related SOPs

Task Delegation/Signature Log (MS Word)
Test Article Accountability
Test Article Disposition and/or Return to Sponsor
Test Article Shipping Receipt Log 

 
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