Subject Visits & Study Operations
Information on the day-to-day operations of a clinical study, including data entry, AE/SAE reporting and subject interaction best practices.
Quick Reference Guides
- Standard Operating Procedure (SOP) Overview
- Writing SOPs Tips & Templates
- What are Source Documents?
- What is a CRF/eCRF?
- Reading the Research Protocol
- What types of AEs, SAEs and other events need to be reported to the IRB?
- How do I submit Reportable New Information (RNI) in eIRB?
- Study Operations in Study Tracker: Epic, Financials, and Other Considerations
- Lyft Partnership: Charging Research Subject Transportation to a Chartstring [NU Procurement]
- Data Documentation: ALCOA Framework [GalterGuide]
- Resources on Anti-Racism & Health Disparities [GalterGuide]
Document Templates & Checklists
- Protocol Deviation Log Template [IRB]
- Drug/Device Accountability Log Template [IRB]
- Visit Checklist & Research Payment Log [IRB]
- View the full library of Regulatory Document Templates
Video Resources
- Webinar: Overview of the Investigational Drug Service
- Webinar: Clinical Trial Subject Retention & Recruitment
- Presentation: Developing Case Report Forms (Investigator-Initiated Studies) [NIH]
