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Clinical Requests

NCI Formulary Process Overview - Clinical Requests

  1. Investigator reviews list of available agents and the Collaborator's studies of interest, if available, on the NCI Formulary website.
  2. Investigator submits LOI Proposal to NCI PIO mailbox (pio@ctep.nci.nih.gov) and copies the NCI Formulary mailbox (NCIFormulary@mail.nih.gov).
  3. NCI reviews investigator eligibility to participate in the NCI Formulary.
  4. NCI PIO forwards eligible LOI Proposal to Collaborator.
  5. Collaborator has sixty (60) days to review the LOI Proposal.
  6. Collaborator approves/disapproves/pending LOI Proposal, response is sent to NCI PIO and NCI Formulary mailboxes.
  7. NCI PIO informs investigator of approval/disapproval/pending status.
  8. NCI sends Investigator a nonnegotiable MTA. Investigator returns partially-executed MTA to NCI.
  9. NCI fully executes the MTA and returns a copy to the Collaborator and Investigator.
  10. Collaborator and Investigator can now discuss details of proposed research plan and Investigator can begin drafting the Protocol.
  11. Investigator submits the initial draft protocol to NCI PIO and NCI Formulary mailboxes.
  12. 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.
  13. Investigator obtains IRB Approval and develops clinical data reporting set-up for protocol with NCI.
  14. Investigator submits all regulatory documentation (e.g., IND safe to proceed, IRB approval) to NCI PIO and NCI Formulary mailboxes and Collaborator.
  15. NCI PIO notifies Investigator that protocol is ready for activation and that agent supplies may be requested.

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