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Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

1. Name of the research project/assay

2. Description of the assay/method/technology

3. Specific focus of the assay (e.g., cancer detection, diagnosis, prognosis, monitoring, prediction of response in treatment, cancer control and prevention)

4. Purpose of the research project/application

5. Objective of the research project/application

6. Description of well-annotated specimens required for clinical validation

7. Source of well-annotated specimens (NCI-supported clinical trials or other clinical trials/observational cohorts/consortia)

8. Multi-disciplinary team members involved in the application (scientific investigators, assay developers, clinicians, statisticians, clinical laboratory staff)

9. Inclusion of clinical laboratory scientist(s) and statistical experts in the application

10. Clarification that early-stage development of technology or clinical trials are not eligible for funding

11. Integration of the assay into clinical trials as investigational assays/tools/devices.

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