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We Are Going to Run an Investigator-Initiated Trial!?!? What Do We do?

Jun 26, 2019 12:00pm ‐ Jun 26, 2019 1:00pm

Credits: None available.


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 closeout 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:

  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


  • Samantha Sharpe, BA, CCRP, Clinical Research Program Coordinator, Nationwide Children's Hospital

Credits Available

We are going to run an Investigator-Initiated Trial!?!? What do we do?

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Silvia Balladares-Huete
5/11/21 2:41 pm

Investigator-Initiated Trial (IIT) is not a simple trial. Investigator plays two important roles -investigator role and sponsor role. Within each role, there are many multiple roles and responsibilities assigned to be able to comply with the FDA/GCP rules and regulations. The Investigator is the ultimate responsible person for the conduct of the clinical trial. He/she is the leader of the study. The Investigator need to carefully perform a feasibility assessment prior to initiating a clinical trial. Many elements need to be evaluated including protocol development, staff recruitment, labs and data collection, and budget analysis in order for the trial to be successful. The Investigator wears many hats during the conduct of the research study. The clinical Research Industry needs Investigator-Initiated Trial to be able to advance in medicine and research by providing novel drugs and medical devices.