Clinical Researcher Coordinator Training
December 14, 2023
12 p.m. to 4 p.m.
In-person (register in Compass)
This is a series of classes sponsored by the Oregon Clinical and Translational Research Institute. 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. Overall Objectives of the OCTRI Study Coordinator Training Classes:
Increase working knowledge of conducting clinical research at OHSU
The goal of the Essential Regulatory and Source Document class is to increase knowledge of essential regulatory documents and requirements for clinical research documentation
If you have a disability and need an accommodation to attend or participate in this event, please contact an OCTRI Navigator (email@example.com, 503-418-9790) at least five business days before the event.
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
AE and protocol deviation reports
1572/ Investigator Agreements
IRB documentation and membership
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”