Tools & Templates

 Using the following Regulatory Binder Template, you can create your own binder selecting the appropriate document templates to serve the purpose of your study.

QMCR Regulatory Binder Template and Table of Contents
Interventional Protocol Template
Observational Protocol Template
Qualified Investigator Undertaking (QIU)
Data Safety Monitoring Board (DSMB)
Personnel Training
Delegation of Responsibility Log
Adverse Event Log
Pharmacy
Drug Temperature Monitoring
Protocol Violations/Deviations
Subject Visit Tracking Log
Notes-to-File

Case Report Form Samples

Informed Consent

Investigational Product Accountability

Laboratory Certification

Laboratory Normals

Screening and Enrollment Log

Other Templates

Screen Failures/Lost to Follow-up

Serious Adverse Event Reporting

Study Closeout