Regulatory Templates
Below are standardized templates for common regulatory forms and various study logs. For industry studies, your research sponsor may provide a different template. Documents and policies frequently requested by research sponsors are available in the Northwestern University Documentation section.
Visit our Study Approval & Compliance quick-reference page for best practices for regulatory documentation. For information on Complion eRegulatory Binders, please consult the Office of Research.
All templates are authored and managed by the Northwestern University IRB (unless otherwise noted).
Recruitment & Screening Templates
- Screening, Enrollment, & Withdrawal Log
- Eligibility + Inclusion/Exclusion Checklist
- Recruitment Advertisement Log
- Vulnerable Populations Recruitment Checklists & Worksheets
Informed Consent Process Templates
- Informed Consent Form (ICF)
- Consent Process Documentation
- Child Assent & other ICF Supplements
- Short-Form Consents + Translations
Study Initiation, Operations & Subject Visits Templates
- Clinical Trial Agreement (CTA) Template & Standardized Language [OSR]
- Change Request Templates & Checklists [OSR]
- Confidential Disclosure Agreement Requests & Other Non-Funded Negotiations [OSR]
- Protocol Deviation Log
- Drug/Device Accountability Log
- Visit Checklist & Research Payment Log
Regulatory Binder Templates
Northwestern University Documentation
- IRB Standard Operating Procedures
- Northwestern University Pathology Core Lab (CAP/CLIA Certification Documentation)
- The Center for Clinical Research (CCR) Summary of Services
- Sponsored Research Policies [OSR]
- PI Certification, PI Separation/Absence, and other University Guidance [OSR]
- Northwestern University Facilities & Administrative Rates [OSR]
- External IRBs/Reliance Agreements and NU serving as an IRB of Record
- Northwestern University Conflict of Interest in Research Policy [COI Office]
