Documentation of Study Visit Interventions/Observations

Purpose

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.

Templates

Screening/Enrollment

• Demographics CRF
  • Demographics and Contact Form (DOC)
  • Including Health History (DOC)
  • Without Health History (DOC)
• Screening, Enrollment, and Master Log
  • Guide to Using the Screening & Enrollment Log (DOC)
  • Screening & Enrollment Log Template (XLS)
• Subject Contact Information

Study Visits/Phone Visit Documentation

• Urine Pregnancy Test Record
• Vital Signs CRF
  • Vital Signs CRF Example 1
  • Vital Signs CRF Example 2
  • Vital Signs CRF Example 3
• Vital Signs Height/Weight
  • Multiple Visits
  • Single Visit
• End of Study/Early Termination Visit Source Document
• First Dose Documentation
• Follow-up Phone Call
• Telephone Communication Record
• Eligibility Checklist (Inclusion/Exclusion Criteria)
  • Inclusion-Exclusion Checklist
  • Inclusion-Exclusion Checklist with Interview Section
• Medical History
• Phone Screen Checklist
• Physical Exam Form
  • Physical Exam Form Example 1
  • Physical Exam Form Example 2
• Study Visit Source Document
• Study Specific Source Document Template
• Protocol Deviation Form

Memos/Notes to Files

• Action Form
• Note to File
  • Note to File Example 1
  • Note to File Example 2
  • Note to File Example 3
• Running Note
• Correspondence (Research Team/Participant)
• COVID-19 Note to File

Adverse/Serious Adverse Event Documentation

• Adverse Event Example Template
• Adverse Event Tracking Log

Medication Logs

• Concurrent Medications CRF
  • Concurrent Medications CRF – Extended Version
• Concurrent Medications Sheet
  • Concurrent Medications Sheet Example 1
  • Concurrent Medications Sheet Example 2

Study Logs

• Daily Temperature Log
• Delegation of Authority Log
  • Version 1
  • Version 2
• 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