Source Documents

 Protocol Deviation Log Template

The Protocol Deviation Log provides participant-specific documentation of missed visits and other actions that deviate from the protocol.

 Delegation of Authority Log

The Site Signature Log - Delegation of Authority Log is a record of all study personnel and their specific responsibilities, signatures, and dates of involvement during the conduct of a clinical research study.

  Adverse Event Log

The Adverse Event Log provides a template for a study form for collecting information about adverse events that is reviewed by safety monitoring bodies.

 Concomitant Medication Log

The Prior and Concomitant Medications Log provides a template to log prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention.

 Training Log Template

The Training Log provides a template to log all study staff training throughout the duration of the trial.

 Note to File Archive Address Template

 Notes to File Guidance