New Concept Submission (NCS)
The Investigator must complete a New Concept Submission (NCS) via TAP website iir-tap.com . Entering a new concept in the TAP website iir-tap.com is the first required step for Investigators to propose a new concept to TAP via the website for review. Investigators can access the new concept submission template complete it and submit it to TAP through TAP's online system. TAP also requires an Investigator to submit a copy of his or her curriculum vitae (CV) (as well as the CV of any sub-investigators involved in the study) along with the NCS. Once TAP IIR staff receives the online submission notification of the NCS and CV, they will both be forwarded to TAP's New Concept Review Group (NCRG) for consideration.
Documentation for submission of a new concept to TAP:
- Completed NCS
- Current CV of investigator and any sub-investigators
New Concept Review Group
The New Concept Review Group (NCRG) is responsible for reviewing an Investigator's new concept. The NCRG is comprised of physicians and scientific personnel who are experts in clinical development programs. Only personnel of the TAP R&D team are members of this committee.
Based upon scientific and corporate strategies/objectives the Group determines if the new concept is:
- Acceptable
- May proceed directly to New Protocol Submission (NPS) process
- Conditionally Acceptable
- TAP requests minor clarifications that should be addressed in the full protocol and may proceed to New Protocol Submission (NPS)
- Rejected
- Concept is deemed unacceptable
- Deferred
- Concept is on hold and may be reconsidered by the NCRG 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 NCRG's decision in writing and via email.
PLEASE NOTE: The New Protocol Submission must be complete within 3 months of acceptance of the NCS by the NCRG. Progression to Step Two – New Protocol Submission Process does not guarantee that TAP will support an IIR study.