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Coordinating Center for Clinical Trials

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Study Checklists

Biomarker Assays and Imaging Tests Proposals
A document describing the characteristics and performance of each biomarker assay and imaging test proposed for funding, and its role in the trial is required as part of the proposal package. Applicants should refer to the Biomarker Study Checklist for Large, Randomized Phase 2 or Phase 3 Trials or the  Imaging Study Checklist for Large, Randomized Phase 2 or Phase 3 Trials for instructions on what information is needed.

Quality of Life Proposals
A document is required describing the characteristics and performance of each QOL component and/or instrument proposed for funding, and its role in the trial. Applicants should refer to the Study Checklist for Phase 3 Trials with QOL Components for instructions on what information is needed.

Cost Effectiveness Analysis
A document is required describing the rationale and justification of the CEA proposal for funding. The CEA proposal should be a secondary endpoint of the parent concept. Applicants should refer to the Study Checklist for Randomized Phase 3 Clinical Trials with a Control Arm and Cost-Effectiveness Analysis (CEA) Component(s) for instructions on what information is needed.