Submission of a New Concept (NC)

The investigator initially completes the registration screens including submission of their current curriculum vitae (CV) via the Takeda website, www.takeda-iisr.com. An ID and password are received within one business day allowing entry into the New Concept screens.

Entering a New Concept (NC) into the Takeda online website system is the first step for investigators to submit an II-SR study to Takeda for its review. Investigators should access the New Concept template, complete it and submit it through Takeda's online system.

Takeda also requires a co- and/or sub-investigator to register and submit a copy of his/her curriculum vitae (CV) prior to the New Concept being reviewed. The NC, all relevant CVs and supporting documentation will be forwarded to Takeda's New Concept Review (NCR) committee for consideration.

Documentation for submission of a New Concept to Takeda:

• Completed NC
• Current CV of investigator and any co- and/or sub-investigators

New Concept Review

The New Concept Review (NCR) members are responsible for reviewing an investigator's New Concept. The NCR is comprised of Takeda employees (physicians and scientific personnel) who are experts in scientific and clinical development programs. The NCR usually meets once a month to review New Concepts.

Based upon scientific merit and therapeutic strategies and objectives the NCR members determine if the New Concept merits submission of a New Protocol.

Takeda will inform the investigator of the NCR's decision via email.

PLEASE NOTE: If a New Concept merits submission of a New Protocol, the New Protocol must be submitted within four (4) months. Acceptance of a NC and submission of a New Protocol for review does NOT guarantee that Takeda will support the II-SR study.