OHSU

Study Coordinator Training Series

The OHSU Knight Cancer Institute and the Oregon Clinical and Translational Research Institute (OCTRI) will be offering a series of classes for OHSU Study Coordinators. The classes are designed to provide study coordinators with working knowledge of OHSU research policies and operations. The goal is to further the development of highly skilled study coordinators at OHSU. 


Workshops 

  • Analyzing and Implementing a Research Protocol Date:  September 10, 2014
  • Writing and Obtaining Informed Consent Date: October 14, 2014
  • Essential Regulatory and Source Documents Date: November 11, 2014
  • Demystifying Clinical Research Audits Date: TBA

Registration

  • Registration is open to all OHSU employees currently working as Research Coordinators, although previous completion of the Quarterly Clinical Research Coordinator Workshop is highly encouraged.
  • Workshops are limited to 30 students and will be offered on a rotating basis.
  • Registration is on a first come, first serve basis.
  • Continuing Nursing Education Credits will be available for the classes.
  • Registration is through OHSU Trainingforce. The course # is: OCTRISCS. https://trainingforce.ohsu.edu/registration/go.aspx?ot=8&otid=1431  To secure a spot in our next class in the series

Writing and Obtaining Informed Consent

This 4 hour workshop is designed to provide guidance and practical tips for writing and obtaining informed consent from research participants.   The workshop involves lecture, examples, and an exercise on obtaining informed consent.

Class objectives include:

  • How to pull information from the protocol when writing the consent document
  • Choosing the appropriate liability language
  • Choosing the appropriate consent templates and HIPAA forms
  • How to obtain informed consents from a variety of study subjects (decisionally impaired adults, child assent, adults with limited English proficiency)
  • Assessing subject understanding

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Analyzing and Implementing a Research Protocol

This 4 hour workshop is designed to provide an in-depth discussion of the role the study coordinator plays in analyzing and implementing a research protocol at OHSU.  The workshop involves lecture, examples, and hands-on protocol analysis exercise.

  • How to identify key information in a research protocol
  • Differences between a clinical research protocol and a grant
  • How to identify safety procedures and distinguish standard of care from research
  • How to address logistical concerns (location, personnel, OHSU research forms)
  • Epic and research records

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Essential Regulatory and Source Documents

This 4 hour workshop is designed to instruct study coordinators on the essential documentation needed for your regulatory and subject files while conducting a research study.   The workshop involves lecture, examples, and an exercise to help  identify common documentation errors.

Class objectives include:

  • What information is needed in your regulatory files
  • How to adequately record study data/adequate case histories
  • When to use “Notes to File”
  • Epic and research records

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Demystifying Clinical Research Audits

This 2 hour class is designed to provide study coordinators with working knowledge of OHSU research policies and operations related to FDA, Sponsor, and Cooperative Group audits.  The class will include a panel discussion involving coordinators, investigators, and IRB staff who have been through audits.

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Previous Workshop Presentations

Presentations from previous workshops are available for reference:

Registration - OPEN

Space is limited and registration is required to attend.  Registration will be through Trainingforce:  https://trainingforce.ohsu.edu/registration/go.aspx?ot=8&otid=1431  To secure a spot in our next class in the series titled, "Essential Regulatory and Source Documents" please use the link to Trainingforce to sign up.  The course is:OCTRISCS.