Essential Regulatory and Source Documents
Part of the OCTRI Study Coordinator Training Series
May 11, 2023
12 a.m. to 4 p.m.
This is an in person event. Location will be shared after registration.
This is one class in a series of classes designed for OHSU employees who are working as research coordinators. The classes provide in depth education through lecture examples and exercise on clinical research coordinator activities.
The goal of the Essential Regulatory and Source Document class is to increase knowledge of essential regulatory documents and requirements for clinical research documentation.
At the end of the class students should know:
- Essential regulatory documents
- Protocol and amendments
- Investigator Brochure
- AE and protocol deviation reports
- 1572/ Investigator Agreements
- IRB documentation and membership
- Training documentation
- Lab ranges
- Certifications/Accreditations for facilities/services
- Drug/device accountability (shipping, invoices, etc.)
- Subject screening and randomization lists
- How to adequately record study data/adequate case histories
- Source documentation/Medical Records
- ALCOA Research Documentation Standards
- Changes or amendments to source documents
- Case Report Forms
- The Requirements for study document retention
- When to use “Notes to File”