CITI ToolKit FINAL

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CITI Tool Kit FINAL.pdf (542.2 KB)

:mag: Overview of the CITI Program (Effective July 1, 2025)

  • Purpose: Provides required research education for individuals involved in human subjects research at Trinity Health.
  • Platform: CITI Program is the online LMS used for training.
  • Compliance: All learners must stay current with legal, regulatory, and ethical obligations.

:compass: Course Structure

  • Basic Modules: For first-time learners; covers foundational knowledge.
  • Refresher Modules: For renewals; fewer modules and quizzes, typically takes half the time of Basic Modules.
  • Expiration Notifications: Sent 90, 60, 30, 7, and 1 day before expiration, and again after expiration.

:office: Trinity Health Subscription Changes

  • All learners now affiliate with Trinity Health – Michigan Region.
  • Previous ministry sites (e.g., MercyOne, Saint Agnes Medical Center) are now expired.
  • Old courses (e.g., Group 1–10, Fall 2012 Requirement) are archived but certificates remain accessible.

:books: Courses Offered & Requirements

Course Who Needs It Valid For
BSS (Biosafety & Biosecurity) Those shipping biological/hazardous materials 2 years
CRC (Clinical Research Coordinator) Assigned CRC tasks 4 years
COI (Conflicts of Interest) All study team members, IRB staff 3 years
GCP (Good Clinical Practice) All study team members, IRB staff 3 years
HSR (Human Subjects Research) All study team members, IRB staff 4 years
IO (Institutional Official) Institutional/Signatory Officials 4 years
IRB Chair IRB leadership 4 years
RCR (Responsible Conduct of Research) All study team members, IRB staff 4 years

:new: New Courses Added

  • Biosafety and Biosecurity (BSS) – No refresher module; renewal every 2 years.
  • Clinical Research Coordinator (CRC) – Includes supplemental modules; renewal every 4 years.

:question: FAQs Highlights

  • Refresher Courses: Assigned automatically 90 days before expiration.
  • New Hire Transfers: Previous CITI certificates may be accepted but reviewed for gaps.
  • Elective Modules: No longer required.
  • CIP/CCRP Holders: Must still complete Trinity Health CITI education.
  • GCP Updates: Reflect new E6(R3) ICH guidelines as of July 23, 2025.

:paperclip: Attachments Included

  1. Email Address Update Process
  2. How to Affiliate with Trinity Health
  3. Course Completion Requirements Summary
  4. List of Expired Affiliate Sites