Concept Checklist

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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 Study Checklist for for Clinical Trials with Biomarker Assays for Treatment/Symptom Science/Supportive Care Studies or the Study Checklist for Clinical Trials with Imaging Tests for Treatment/Symptom Science/Supportive Care Studies for instructions on what information is needed.

Quality of Life/PRO 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 Clinical Trials with QOL/PRO 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 Clinical Trials with a Comparator Arm and Cost-Effectiveness Analysis (CEA) Component(s) for instructions on what information is needed.