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.
Clinical Trials Office 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
Alberta Health Services
Case Report Form Samples
- Adverse Events
- Demographics
- Inclusion Exclusion Criteria
- Medical History I
- Medical History II
- Physical Exam
- Prior and Concommitant Medications
- Protocol Deviations
- Randomization and Enrollment
- Serious Adverse Events
- Study Completion
- Visit Checklist
- Vital Signs
Informed Consent
- Informed Consent Document Templates
- Informed Consent Process Worksheet
- Informed Consent Documentation for Patient Chart
Investigational Product Accountability
- Device Accountability Log
- Drug Accountability Log
- Investigational Product Subject Compliance Tracking Tool
Laboratory Certification
- Lab Training Documentation
- AABB Certificate of Accreditation
- College of American Pathologists Lab Accreditation
- College of Physicians and Surgeons of Alberta Diagnostic Lab Accreditation
Laboratory Normals
Screening and Enrollment Log
Other Templates
Screen Failures/Lost to Follow-up
Serious Adverse Event Reporting
Study Closeout