Clinical Requests
NCI Formulary Process Overview - Clinical Requests
- Investigator reviews list of available agents and the Collaborator's studies of interest, if available, on the NCI Formulary website.
- Investigator submits LOI Proposal to NCI PIO mailbox (pio@ctep.nci.nih.gov) and copies the NCI Formulary mailbox (NCIFormulary@mail.nih.gov).
- NCI reviews investigator eligibility to participate in the NCI Formulary.
- NCI PIO forwards eligible LOI Proposal to Collaborator.
- Collaborator has sixty (60) days to review the LOI Proposal.
- Collaborator approves/disapproves/pending LOI Proposal, response is sent to NCI PIO and NCI Formulary mailboxes.
- NCI PIO informs investigator of approval/disapproval/pending status.
- NCI sends Investigator a nonnegotiable MTA. Investigator returns partially-executed MTA to NCI.
- NCI fully executes the MTA and returns a copy to the Collaborator and Investigator.
- Collaborator and Investigator can now discuss details of proposed research plan and Investigator can begin drafting the Protocol.
- Investigator submits the initial draft protocol to NCI PIO and NCI Formulary mailboxes.
- Once the protocol is final, Investigator submits protocol and Collaborator approval notice to NCI PIO and NCI Formulary mailboxes, and submits IND Application to FDA.
- Investigator obtains IRB Approval and develops clinical data reporting set-up for protocol with NCI.
- Investigator submits all regulatory documentation (e.g., IND safe to proceed, IRB approval) to NCI PIO and NCI Formulary mailboxes and Collaborator.
- NCI PIO notifies Investigator that protocol is ready for activation and that agent supplies may be requested.