Study Initiation

As a clinical and translational investigator, we know you are busy. The Clinical Research Unit staff aims to make the study initiation process smooth yet thorough to ensure the best possible outcomes from your research activities. Following the steps below helps the CRU staff fully understand your request, plan for your study, and ensure our services best meet your needs.

If you have any questions regarding the study initiation process or need help compiling information, please contact CRU Nursing Manager Barbi Lange.

  1. Preliminary Investigator Meeting (CRU Nursing Manager and Principal Investigator)
  2. Submission of protocol, consent form, and other study documents to the UTSW Investigational Review Board (IRB) via eIRB; also submit any available study documents (including budget and coverage analysis) to CRU
  3. CRU Protocol Review Committee Meeting (Medical Director, Pharmacy, Nursing Manager, Business Analyst)
  4. Letter of Agreement (LOA) drafted and circulated for signatures
  5. iLab In-service for study team (if needed)
  6. CRU Staff In-service