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If your protocol is being funded through an external funding source (pharmaceutical company, foundation, etc.), Protocol Development can act as a liaison between the investigator and the funding source facilitating protocol transmission. The funding source must review and approve the initial version of the protocol prior to us moving forward with regulatory submissions.


Depending upon the funding source, this process may vary. If a restricted access portal is set-up, submission may be the responsibility of the investigator, at least initially. Please Note: We do not share or use login credentials from other individuals. After approval of the protocol by the funding source, sometimes portal access may be granted to other individuals within Lineberger that are involved in protocol development and maintenance. The investigator can request a member of the Protocol Development team be granted access to this portal; however, even in these cases, access is still likely restricted at some level to only submission. In other cases, submission to the funding source may simply involve emailing drafts of the protocol to the funding source representative, which Protocol Development can do for the investigator.


While Protocol Development may assist in the development of protocols for NIH grants and may aid in the writing of grant submissions, we do not submit grants.


For CTEP protocols, Protocol Development can help with generating protocols with CTEP funding. However, the Principal Investigator may also utilize the CTEP protocol working group (currently known as Centralized Protocol Writing Support [CPWS]) either in conjunction with LCCC Protocol Development or alone. CPWS works with the investigator (and LCCC Protocol Development) to aid in protocol and consent development, help address reviewer comments, and provide protocol submission services to CTEP and CIRB. After CTEP approval, the protocol is then activated through CTEP processes and not through the other LCCC clinical development steps; however, it may be in your best interest to still involve our IND team as they will provide you with strategic advice.