Clinical Investigator Training Program (CITP) – A practical and pragmatic approach to conveying clinical investigator competencies and training to busy clinicians

Mansoor Saleh, Gurudatta Naik, Penelope Jester, Cynthia Joiner, Elizabeth Westfall, David W. Kimberlin, James Willig, David Redden, Juliette Southworth, Mark T. Dransfield

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


Introduction: Clinical investigation is a critical component of clinical medicine. Yet, other than mentorship by an experienced senior physician, young physicians have few formal training opportunities that fit into their clinical training and convey the pre-requisite clinical investigator competencies. To address this training gap, we designed the Clinical Investigator Training Program (CITP); a practical and pragmatic curriculum weaved into the constant pressures of balancing patient care with academic pursuit required of the academic practitioner. Methods: Between January 2016 and December 2018, we conducted four CITP courses, with each comprised of four 4-h sessions that included didactic lectures, group projects including the development of a mock clinical protocol, and expert's panel discussions. Each course enrolled 15 participants from an average of 28 applicants. We assessed the knowledge acquired following each course via a pre- and post-course test (t-test with positive scores indicating improvement in knowledge base). In addition, we also tracked which participants became first time principal investigator following completion of CITP. Results: A total of 60 participants enrolled in the 4 CITP courses, and there was a statistically significant improvement in mean post-test scores (p < 0.01). The number of participants achieving first time principal investigator status nearly doubled following CITP from 17 to 33. Conversely, applicants not selected for CITP demonstrated no similar improvement during the same follow up period. Conclusion: The improvement in test scores and the substantive uptake in first time principal investigator responsibilities following CITP affirms that CITP provides a viable option to convey investigator competencies and encourage clinicians to take on the role of principal investigators.

Original languageEnglish
Article number100589
JournalContemporary Clinical Trials Communications
Publication statusPublished - Sept 2020
Externally publishedYes


  • Academic
  • Clinical investigation
  • Outcome
  • Training program


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