Documentation Audit
· Patient information/patient informed consent forms
· Case Report Forms (CRF)
· Trial Master Files (TMF)
The purpose of the essential documents required for creation of the TMF is to allow the conduct of the clinical trial and the quality of the data to be evaluated and to ensure that the trial is being run in compliance with the regulations.
All files shall be established at the beginning of the clinical study and updated throughout the study. Trial Master File must be readily available for monitoring or audit.
Timely audit of Trial Master File may draw attention to deficiencies and nonconformities in clinical trials conduct.