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IRB Submissions

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THMA Institutional Review Board submission requirements

THMA requires researchers and IRB members to complete the required courses offered through the CITI subscription website.

To access:

  • Go to www.citiprogram.org and register.
  • Once there, click on “Register.”
  • In the “Select your organization affiliation” section, select “Trinity Health-MidAtlantic” in the “Participating Institutions” drop-down box. 

    NOTE: Selecting the incorrect institution may lead to the completion of different or unnecessary modules.
  • Click “Continue To Create Your CITI Program Username/Password” − Complete Steps 1 thru 7
  • Select your role in research under − “Please choose your primary role in human subjects research activities:”

The following courses are required:

  • Human Subjects Research (HSR) – complete every four years
  • Conflict of Interest (COI) − complete every four years
  • Responsible Conduct of Research (RCR) − complete every four years

Good Clinical Practice (GCP) – complete every three years if your study is a clinical trial*

  • You will need to add the GCP course to “My Courses:”
  • Select "Add a Course" → “*Good Clinical Practice Course*”

*GCP Training is required by: All Investigators, study coordinators, and research staff who are involved in the conduct, oversight, or management of a clinical trial or clinical investigation no matter the source of the funding, are required to complete Good Clinical Practice (GCP) education and training. Training is offered for individuals involved in clinical trials of drugs, biologics, and devices. This training will need to be completed every three (3) years.

You may use multiple logon sessions to complete the course. The minimum score for passing each of the required courses is 80%.

Upon completion of the required course, save and retain the completion record to your computer/research files. You will need to submit this completion record with any Application for Initial Review and as necessary during the conduct of a study.

For more information, see IRB policy: Education and Training on Human Subjects Protections.

How to submit

The THMA IRB now utilizes IRBManager for electronic submissions. Please contact MHSSMIRB@mercyhealth.org or llupinacci@stmaryhealthcare.org for more information.