The purpose of source documentation is to reconstruct the research study as it happened. It should allow for data to be confirmed, validated, and support the fundamental principle of protecting the participant’s rights, safety and well-being.
These templates are intended to assist in documenting study procedures, interventions, observations, etc.
Below are several examples that can be customized to meet your specific study needs/requirements.
Best Practice Considerations
The research record should contain documentation of each participant’s study involvement from the time they sign consent through to whatever point they complete participation.
- Study source documentation should be completed to the fullest extent.
- Anything not completed should include record of why and be signed and dated by the person completing the note.
- Attaching a note to file or documenting in a running note missing items, dates, incomplete questions, missing assessments, etc., is another way to document why a record is incomplete, but the note to file entry must also be signed and dated.
- With electronic study documentation, consider creating a data field to capture any general notes about why study interventions were not completed or were partially complete
Hardcopy source documents/data collections forms should contain at the very least the HRPO#, participant ID, and study visit date on each loose page.
Research team members should document each task they perform.
- Demographics CRF
- Screening, Enrollment, and Master Log
- Subject Contact Information
Study Visits/Phone Visit Documentation
- Urine Pregnancy Test Record
- Vital Signs CRF
- Vital Signs Height/Weight
- End of Study/Early Termination Visit Source Document
- First Dose Documentation
- Follow-up Phone Call
- Telephone Communication Record
- Eligibility Checklist (Inclusion/Exclusion Criteria)
- Medical History
- Phone Screen Checklist
- Physical Exam Form
- Study Visit Source Document
- Study Specific Source Document Template
- Protocol Deviation Form
Memos/Notes to Files
- Action Form
- Note to File
- Running Note
- Correspondence (Research Team/Participant)
- COVID-19 Note to File
Adverse/Serious Adverse Event Documentation
- Concurrent Medications CRF
- Concurrent Medications Sheet
- Daily Temperature Log
- Delegation of Authority Log
- Deviation Log
- Device Dispensing Log
- Drug Dispensing Log
- PI Delegation Log
- Receipt Log
- Specimen Collection Log
- Specimen Shipping Log
- Study Device Accountability Log
- Study Drug Accountability Log
- Study Personnel Log
- Study Team Contact Log
- Telephone Call Log
- Screening and Enrollment Log Guide and Template