Forms and Templates

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

Study Visits/Phone Visit Documentation

Memos/Notes to Files

Adverse/Serious Adverse Event Documentation

Medication Logs

Study Logs