CONCEPT DEVELOPMENT

Protocol Concepts for Oncologic Trials

1. Concepts approved by the Steering Committee undergo further development and are submitted as more complete concepts to the NCI Cancer Therapy Evaluation Program (CTEP).

The disease site committee adds members to the trial team, including the naming of a trial principal investigator (PI). The trial team adds detail to the concept and prepares it for submission to CTEP. Concepts submitted to CTEP must use the ACRIN Protocol Concept Submission template.

ACRIN Protocol Concept Submission Template [DOC]

2. Following the recommendation by CTEP, the Steering Committee makes a final determination of whether it will pursue protocol development and open the trial.

The principal consideration is whether ACRIN has the financial resources and personnel required.

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