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Clinical Trial Concept Submission Guidelines

A concept contains scientific background, preliminary data, a hypothesis, and a plan for study implementation including statistical design. Concepts for large phase 2 and phase 3 trials must be reviewed by an NCI steering committee (SC) appropriate to the disease or topic area before a full protocol can be developed.

NCTN Steering Committees

Before submitting a clinical trial concept, please refer to the 2024 and 2025 SSC meeting and concept submission deadline schedules. To be considered for evaluation at the next scheduled NCTN SC meeting:

  • New concepts must be submitted at least four weeks prior to the meeting
  • Revised concepts must be submitted at least two weeks prior to the meeting

Find the concept submission form on the CTEP website.

NCORP - Cancer Control Committees

Symptom Management and Health-Related Quality of Life (SxQoL) Steering Committee

Both new and revised concepts must be submitted at least four weeks prior to the next scheduled SxQOL SC meeting to be considered for evaluation at that meeting. See the 2024 and 2025 SSC meeting and concept submission deadline schedules.

Submissions should be emailed to the DCP Protocol and Information Office (PIO) at nci_dcp_pio@mail.nih.gov.

For more information, review the SxQOL SC Concept Template and Guidelines and find the Clinical Trials Document Submission Worksheet on the DCP website, under the Clinical Trials section.

Cancer Care Delivery Research (CCDR) Steering Committee

Refer to the 2024 and 2025 SSC meeting and concept submission deadline schedules, when submitting a concept. To be considered for evaluation at the next scheduled CCDR SC meeting:

  • New concepts must be submitted at least four weeks prior to the meeting
  • Revised concepts must be submitted at least two weeks prior to the meeting

For more information, review the CCDR SC Concept Template and Guidelines, concept review forms (scientific, advocate, and statistical), and find the NCORP Cancer Care Delivery Submission Worksheet on the DCP website. Email submissions to the DCP PIO at nci_dcp_pio@mail.nih.gov.

Cancer Prevention Steering Committee (CPSC)

Both new and revised concepts must be submitted at least four weeks prior to the next scheduled CPSC meeting to be considered for evaluation at that meeting. See the 2024 and 2025 SSC meeting and concept submission deadline schedules.

For more information, review the Guidelines for CPSC Study Concept Submission, and find the Clinical Trials Document Submission Worksheet on the DCP website. Email submissions to the DCP PIO at nci_dcp_pio@mail.nih.gov.

 

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