The Association of Clinical Research Professionals

Webinar Replay: We Are Going to Run an Investigator-Initiated Trial!?!? What Do We Do?

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires June 26, 2022.

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay Expires June 26, 2022.


  • Samantha Sharpe, Clinical Research Program Manager, Nationwide Children’s Hospital

Starting an Investigator-Initiated Trial (IIT) can present a multitude of challenges. As the sponsor institution and program manager, there are numerous tasks to consider from budget and invoicing to specimen collection and transport to training and monitoring to investigator-facing issues such as publication and data management. This session will communicate effective, simple checklists and best practices for study start up, patient recruitment, tracking of study progress, training and technology resources, and study close out and reconciliation. Examples will be provided for invoicing templates, laboratory manual, authorship guidelines, and more tricks and tools developed and used through the course of an IIT.

Learning Objectives

Upon completion of this Webinar, attendees should be able to:

  1. Review roles and responsibilities to consider when launching an Investigator-Initiated Trial.
  2. Discuss common “blind spots” for IIS and how to navigate them.
  3. Explore the “site as sponsor” concept.