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.

Objectives

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”