Scientific Review
For access to biospecimens, the Feasibility Query for Specimen Request and Access to CGB Specimens (PDF) and/or the Biospecimen Access Application for using CGB Specimens (PDF), must be completed and submitted to the Cooperative Group (or Lead Group for Intergroup studies). All requests will be considered. Access to biospecimens will be based on specimen availability and overall merit of the proposal. All Cooperative Groups maintain committees that review applications for use of specimens.
A well-defined and compelling hypothesis and testing protocol with statistical plan should be described by the applicant along with a description of the type and number of specimens required for the project. The application should include:
- preliminary data;
- evidence of clinical utility;
- clear standards for specimen preparation;
- assay performance and assay interpretation;
- statistical power calculations;
- suggested description of potential cost-sharing approaches that can be developed with entities that would eventually commercialize the assay/test/marker, if applicable; and
- description of quality assurance/quality control (QA/QC) methods, if applicable.
