OCTRI: Essential Regulatory and Source Documents

Clinical Researcher Coordinator Training

December 14, 2023
12 p.m. to 4 p.m.

In-person (register in Compass)

Contact Information

Class Description

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 (octri@ohsu.edu, 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
    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”