Biorepositories for NCI-Sponsored Cancer Clinical Trials

Access Process

The application and approval process is outlined in the process flow diagram and includes the following steps:

  1. Contact the Cooperative Group of interest to determine availability of the biospecimens.
  2. Completion and Evaluation of a Feasibility Query (PDF)

    The completed Feasibility Query form is evaluated for feasibility by the respective CGB and the Groups’ statistical/operations offices.

  3. Completion of a Biospecimen Access Application (PDF)

    After feasibility is determined, the requesting investigator completes an Application, providing more detailed information about the proposed study, and submits it directly to the Cooperative Group of interest that was contacted in Step 1.

  4. Review of the Application
    • The Application is reviewed for scientific merit and alignment with the CGB mission using a tiered approach.
    • Designated Cooperative Group Review committees and/or disease-specific NCI Correlative Science Committees review the Application for scientific merit, independently from the Cooperative Group.
    • The review process depends on the nature of the study under which the specimens were collected (e.g., single group, multiple groups/Intergroup, etc.).
      • For single-group-led, non-Intergroup studies, the Application is reviewed via the respective Cooperative Group responsible for biospecimen procurement and distribution for a clinical trial (typically the lead group of a particular trial) along with input from its review committee for scientific merit. 
      • For Intergroup studies (studies with multiple group involvement in the collection of the specimens), the Application is reviewed by a disease-specific NCI Steering Committee or a peer-review group formed by the NCI and Cooperative Groups contributing samples.
    • Depending on the number of samples requested and the study under which the specimens were collected, review by other oversight committees, such as the NCI’s Clinical Trials Evaluation Program (CTEP) Protocol Review Committee (PRC) may also be required prior to release of specimens.
  5. Submission of Appropriate Regulatory and Legal Documentation (after approval)
    • IRB/Ethics Committee review/approval notification
    • Material Use Agreement/Material Transfer Agreement (MUA/MTA) and funding commitment
    • Statement describing potential financial conflict of interest (as outlined in the CGB MUA). Check for sample use consistent with consent form permissions, as appropriate (performed by the respective CGB)
  6. Release of biospecimens by the CGB for the approved project to the requesting investigator.

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