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Investigator Initiated Trials (IIT) Advisory Committee


The mission of the Yale Cancer Center (YCC) Investigator Initiated Trial (IIT) Advisory Committee is to support IIT protocol development to ensure YCC-investigator initiated research is highly successful and impactful.

The IIT Review Committee functions to:

  1. Support investigators in the planning and scientific development of IITs to improve the feasibility, scientific merit, and success of YCC IITs.
  2. Create and foster a research culture that yields highly impactful YCC-investigator initiated research which aligns with the YCC mission and meets the needs of the catchment area.
  3. Offer consultation to investigators regarding collaboration with external entities, third-party vendors, and internal partners.
  4. Facilitate access to protocol development support, project management, regulatory management, statistical support, and budget development resources.
  5. Review trial feasibility and financial viability.


The YCC IIT Advisory Committee is charged with the reviewing all cancer and cancer-related, investigator initiated, clinical trials proposed at Yale. The IIT Advisory Committee has a two-phased review. The initial review is at the concept level. This review should be done as soon as an Investigator begins considering an IIT. The second review is after the protocol is developed. The IIT Advisory Committee’s review encompasses the project’s scientific impact, proposed design, participant enrollment and impact on local patient needs, as well as considerations for engagement of external funders and collaborators, financial factors, and regulatory implications.

The IIT Advisory Committee functions to assign Investigators resources to support development of IIT protocols, and corresponding protocol documents, as well as to connect investigators to staff who will assist in the regulatory, administrative, and operational steps towards trial initiation.

Frequently Asked Questions

When should I submit a concept for review?

We encourage you to submit your concept as soon as possible. This initial concept review is meant to be an informal setting to discuss your IIT concept and does not require a significant amount of preparation. The IIT Advisory Committee is a resource for scientific feedback from colleagues at YCC, and if your concept is accepted, the IIT Advisory Committee will connect you with resource to support development of your study protocol, drafting corresponding documents, budget development, regulatory submissions, and operational plans.

How do I submit a concept for consideration?

To submit a concept for review at a IIT Advisory Committee meeting use the IIT Advisory Committee Concept Submission Form. You will be invited to present at an upcoming meeting. You will be asked to present 3-4 slides containing and overview of the project. Please email for the slide deck template.

When does the IIT Advisory Committee Meet?

IIT Advisory Committee Meetings occur the 1st and 3rd Friday of each month. Submission deadlines are posted below.

What should I expect during the review?

Committee members will discuss the concept with you during the meeting. After the scientific portion, there will be an operational discussion regarding relevant aspects of your project including budgetary considerations, regulatory submission requirements (FDA & IRB), and any unique project characteristics that could impact your start up timeline.

What is required for the second IIT Advisory Committee review?

After your protocol is in final draft, and your full budget has been developed (including MCA), the following documents will be submitted to the committee via email.

  1. Submission Ready Protocol
  2. Full Cost Budget
  3. Total Funding Committed
  4. A Letter of Intent from all applicable parties (Manufacturer providing IP and/or Funding Agent)

Committee Chair

2024 Meeting Dates and Submission Deadlines

Meeting Dates Submission Deadline
Friday, January 05, 2024 Friday, December 22, 2023
Friday, January 19, 2024 Friday, January 12, 2024
Friday, February 02, 2024 Friday, January 26, 2024
Friday, February 16, 2024 Friday, February 09, 2024
Friday, March 01, 2024 Friday, February 23, 2024
Friday, March 15, 2024 Friday, March 08, 2024
Friday, April 05, 2024 Friday, March 29, 2024
Friday, April 19, 2024 Friday, April 12, 2024
Friday, May 03, 2024 Friday, April 26, 2024
Friday, May 17, 2024 Friday, May 10, 2024
Friday, June 07, 2024 Friday, May 31, 2024
Friday, June 21, 2024 Friday, June 14, 2024
Friday, July 05, 2024 Friday, June 28, 2024
Friday, July 19, 2024 Friday, July 12, 2024
Friday, August 02, 2024 Friday, July 26, 2024
Friday, August 16, 2024 Friday, August 09, 2024
Friday, September 06, 2024 Friday, August 30, 2024
Friday, September 20, 2024 Friday, September 13, 2024
Friday, October 04, 2024 Friday, September 27, 2024
Friday, October 18, 2024 Friday, October 11, 2024
Friday, November 01, 2024 Friday, October 25, 2024
Friday, November 15, 2024 Friday, November 08, 2024
Friday, December 06, 2024 Friday, November 29, 2024
Friday, December 20, 2024 Friday, December 13, 2024