The goal of the Essential Regulatory and Source Document class is to increase knowledge of essential regulatory documents and requirements for clinical research documentation.
February 4, 2020
8:30 a.m. to 12:30 p.m.
3455 SW US Veterans Hosp Rd
Portland, Oregon 97239
This is a series of classes sponsored by the Oregon Clinical and Translational Research Institute (OCTRI). The classes are designed for OHSU employees who are working as research coordinators.
The intent of the program is to provide in depth education through lecture, examples, and exercises on clinical research coordinator activities. The overall objective of the OCTRI Study Coordinator Training Series is to increase working knowledge of conducting clinical research at OHSU.
The goal of the OCTRI Essential Regulatory and Source Document class is to increase knowledge of essential regulatory documents and requirements for clinical research documentation.
At the end of class students should know and identify:
- Essential regulatory documents (1572, protocol, Investigator Brochures, etc.)
- How to adequate record study data and maintain adequate case histories
- Requirements for study document retention
- When to use "Notes to File"
- 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”
Registration in Compass is required to attend.