Regulatory Documents

The materials offered below are commonly referred to as regulatory documents. These documents help to serve investigators in organizing their research so that it follows the standards of Good Clinical Practice and all other applicable regulatory requirements.

A trial master file should be established at the beginning of any research study and maintained throughout the study, and regulatory documents should be housed in this trial master file. This file aids in the management of the study and is often a piece that is audited by study monitors and FDA officials.

Regulatory documents Attachments
Adverse Event Tracking Log
Delegation Log
IRB Submission Log
Note to File Template
Protocol Deviation Tracking Log
Screening and Enrollment Log