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Provide Agents

Process Overview for Companies

  1. Submit agent pledge letter to NCI.
  2. Negotiate cooperative research and development agreement with NCI for pledged NCI formulary agents.
  3. Submit agent investigator brochure and completed company and agent information intake forms to NCI for posting on the NCI Formulary website.
  4. Once agreement is executed, review Investigator LOI proposals provided by NCI; render decision (approval/disapproval) to NCI within 60 days of receipt.
  5. If proposal is approved, develop and finalize protocol with investigator.
  6. Work with NCI on agent forecasting and provision of agent supplies to support approved proposal during protocol development.
  7. Provide initial necessary agent information to NCI and throughout trial (e.g., IB updates, agent lot certificates of analysis, cGMP certification, stability test results) to facilitate conduct of protocol and agent distribution.
  8. Provide notice of protocol approval to NCI and Investigator; support Investigator’s IND filing by providing Letter of Authorization to company sponsored IND or Master File for protocol agent(s).
  9. Investigator will provide Pharmaceutical Collaborator with copies of regulatory documentation to enable NCI acknowledgment that protocol is ready for activation.
  10. Investigator will provide Pharmaceutical Collaborator required trial data and documentation throughout conduct of protocol.
  11. If required, audit the conduct of the research and obtain updates on ongoing clinical trials at times convenient to the clinical sites.

Company Responsibilities

Forms and Templates

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