New Protocol Submission (NPS)

Upon notification your new concept is acceptable or conditionally acceptable (and following discussion with TAP MERL, if applicable) the Investigator finalizes the full protocol, by completing the New Protocol Submission (NPS) and a TAP Resource Request. The Resource Request (funding and/or drug) is used to describe the support requested from TAP.

The completed New Protocol Submission (NPS), TAP Resource Request, and any supporting documentation are submitted to TAP via the website iir-tap.com. TAP will then conduct a critical scientific review of the protocol as well as, review for alignment with scientific strategies/objectives for TAP's compounds and therapeutic areas of focus.

Documentation required for submission of a new protocol to TAP:

• Completed NPS
• Completed Resource Request Template (funding and/or drug)

Once TAP IIR staff receives the online submission notification of the completed NPS and resource requests for funding and/or drug, they will be forwarded to TAP's Clinical Trial Review Committee (CTRC) for review.

Clinical Trial Review Committee (CTRC)

TAP's Clinical Trial Review Committee (CTRC) is responsible for reviewing and considering an Investigator's new protocol. The CTRC is a multi-disciplinary committee that is comprised of physicians and scientists in research and development. Only personnel of the TAP R&D team are members of this committee. The MERL will present the new protocol to the Committee, representing the Investigator, and answering any questions.

Based upon a critical scientific review and patient risk/benefit (if applicable), the Committee will determine if the protocol is:

• Acceptable
  • May proceed to Accepted Protocol Submission (APS)
• Conditionally Acceptable
  • TAP requests minor clarifications that once received, reviewed and approved will enable the NPS to be considered acceptable and may proceed to Accepted Protocol Submission (APS)
• Rejected
  • Protocol is deemed unacceptable and may not be resubmitted
• Deferred
  • Protocol is on hold and may be reconsidered by the CTRC at a later date. The investigator may be requested to provide additional information during this time.

The IIR Staff will inform the Investigator of the CTRC's decision in writing and via email.

PLEASE NOTE:

All Study Agreements for IIR projects must be fully executed within three (3) months of notification of acceptable by the CTRC. If not, TAP reserves the right to defer the study.

All IRB approvals must be received within 3 - 6 months of notification of acceptance by the CTRC. If not, TAP reserves the right to defer the study.