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Mandatory Training for Clinical Trial Investigators


Mandatory Training for Clinical Trial Investigators

All Internal Medicine principal investigators of interventional clinical trials are required to complete training in the practical oversight of clinical trials.  If you question whether your research fits the NIH definition of an interventional clinical trial, this link will be helpful: https://grants.nih.gov/policy/clinical-trials/definition.htm.

Options to Meet Training Requirement

Three options are available for Internal Medicine investigators to meet this new training requirement.  Please select and complete one of the three options below:

  1. Completion or enrollment in the Master of Science in Clinical Investigation (MSCI) program: https://medicine.utah.edu/ccts/workforce-development/msci/
  2. Completion or enrollment for credit in MDCRC 6040: Design and Implementation of Clinical Trials
  3. Completion of or teaching in the Internal Medicine “How to be a PI in Clinical Research” half-day seminar

If you have already completed one of the training options above, please provide the details and dates to Dr. Adam Cohen (adam.cohen@hci.utah.edu), Clinical Research Compliance Director, Department of Internal Medicine.

How to be a PI in Clinical Research Seminar

The “How to be a PI in Clinical Research” seminar will be offered several times over the coming months to facilitate attendance.  Topics covered in this seminar include: institutional processes for initiating a clinical trial; feasibility assessments & budget review; proper documentation of informed consent and adverse events and deviations; cultivating a successful relationship with your research coordinator; and identification of key resources to support your clinical trial.

If you have not completed option 1 or 2 above to meet the training requirement, please plan on attending one of the “How to be a PI in Clinical Research” seminars.  Currently scheduled seminars are on:

  • August 21 8:30 – 12:00             HSEB 2120
  • September 14 8:30 – 12:00       HSEB 4100B
  • October 8 8:30 – 12:00             HSEB 4100B
  • November 8 8:30 – 12:00          HCI Research South, 1st floor Auditorium
  • December 12 8:30 – 12:00        HSEB 4100B

To RSVP for the Seminar: If you plan to attend one of the scheduled seminars above, please RSVP, if possible, to calee.hulet@hci.utah.edu for the date of attendance, as this will help in planning for handouts and food.

If you absolutely cannot attend any of these dates and have not completed either of the other training options, please contact Adam Cohen (adam.cohen@hci.utah.edu), Internal Medicine Clinical Research Compliance Director. Other training dates may be added to accommodate schedules in order to meet this commitment, or Dr. Cohen may come to a division faculty meeting to discuss further.

For more information or questions, contact Scott Low, DOIM Research Administration: scott.low@hsc.utah.edu, 801-585-1380