Study Documentation Templates and Tools

During planning and operationalization stages, before enrollment starts, research teams should discuss what forms will be needed for their study. These could be data collection forms, source documentation, even forms or logs for study management like visit checklists and progress notes.

In general, templates are an efficient way to build study documents but care needs to be taken that edits are made that are relevant and appropriate for each study. Study teams can use these templated tools and edit for each new study or can build their own templates based on their usual needs to use for all future studies.

The CRRO templated tools are not meant to be static, unchanging documents, but must be edited for each study to align with IRB-approved procedures that are in the INSPIR application, protocol, or other study document. However, not all templated tools that are available will be required or should be used on every study. Study teams should review all available tools and what will be needed for compliant and complete documentation.

CRRO templated tools are built upon a mix of institutional policies, federal regulations, ICH Good Clinical Practice, and current best practices. The CRRO cannot make any guarantee that these templated tools follow current policy or regulations as those may change without warning or announcement. These templated tools are not meant to be used as a policy or guidance document.

It is strongly recommended that study teams review the Overview and Instructions prior to using any of the templated tools. General questions on how to use these forms or implement them for a specific study can be answered by contacting the CRRO. Specific guidance on building these tools within Word, REDCap, or other systems are available from the CRRO. 

Suggestions for additional tools or changes to current tools are welcome and can be submitted on our Tool Recommendation Form.

Adverse Event Form
Adverse Event Log
Biospecimen Storage and Tracking Log
Delegation of Authority and Responsibilities
Eligibility Criteria Checklist
Essential Documents Location Cover Page
Informed Consent Documentation
IRB Submissions Log
Note to File Template
Participant Completion Form
Participant Identification Log
Phone Call Summary Report
Pregnancy Testing Documentation
Protocol Deviation Form
Protocol Deviation Log
Regulatory Binder Cover Page
Schedule of Events
Screening and Enrollment Log
Site Visit Log
SOP or MOP Template
Staff License Log 
Training Log – Group
Training Log – Individual
Visit Checklist 

FAQs on Regulatory Documentation
Regulatory Binder Tabs
REDCap e-Reg Lite 
AdobeSign Guidance