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Procedures for Trial Conduct by Companies

  1. After the NCI receives a letter of intent (LOI) proposal from an investigator, the Pharmaceutical Company Collaborators are responsible for providing scientific review. They must render an approval or disapproval decision to NCI within 60 days after receipt of the drug commitment form. 
  2. If a proposal is approved, the Clinical Investigator will develop the protocol with the Pharmaceutical Collaborator(s). The Clinical Investigator must also provide the initial protocol draft and final Pharmaceutical Collaborator approved version of the protocol to the NCI for NCI Formulary agent forecasting purposes.
  3. The Pharmaceutical Collaborator works with the NCI to forecast and provide agents to support the approved proposal during protocol development.
  4. The Pharmaceutical Collaborator provides all necessary agent information to the NCI initially and throughout the course of the trial (e.g., IB updates, agent lot certificates of analysis, cGMP certification, stability test results). This facilitates the conduct of both the protocol and agent distribution.
  5. The Pharmaceutical Collaborator approves the final version of the protocol and sends the approval documentation to the Clinical Investigator and NCI. The approval is used to support the Cancer Center/Clinical Investigator's IND filing by providing cross-referenced authorization for the Pharmaceutical Collaborator(s) IND or Drug Master File to the extent required for conducting the clinical investigation.
  6. The Pharmaceutical Collaborator approves all protocol amendments before the Clinical Investigator implements the amendment.
  7. The IND sponsor sends clinical trial data reports and safety data to the Pharmaceutical Collaborator.
  8. The Pharmaceutical collaborator must make arrangements with the clinical sites to audit the conduct of the research. They can also obtain updates on ongoing clinical trials at times convenient to the clinical sites, if required.  The Collaborator may also arrange with research sites to audit and verify raw data and source documents. This may be done, at the completion of a protocol and at the collaborator's expense, to the extent necessary to verify compliance with the federal regulations, Good Clinical Practice (GCPs) and the protocol. This ensures patient safety.
  9. If the Collaborator informs the FDA of any serious and unexpected adverse events involving the formulary agent(s) that arise outside of the formulary protocol, the Collaborator must notify the IND sponsor and NCI at the same time.

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