Regulatory Document 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 can be found in the NU Documentation section.
Visit our Study Approval & Compliance quick-reference page for regulatory documentation best-practices. For information on Complion eRegulatory Binders, please consult the Office of Research.
All templates are authored and managed by the NU 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
NU Documentation
- IRB Standard Operating Procedures
- NU 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]
- NU Facilities & Administrative Rates [OSR]
- External IRB’s/Reliance Agreements and NU serving as an IRB of Record
- NU Conflict of Interest in Research Policy [COI Office]
