Step 2: Conducting a Cancer Prevention Clinical Trial
Quality Control
The contractor shall establish mechanisms for quality control of therapeutic and diagnostic modalities used in the trials. At a minimum, quality control shall consist of:
- Pathology: Review and verification of pathologic diagnosis in all cases. Review of other pathology data such as special stains, if diagnosis or management decisions were based on these.
- Surgery: Assessment of adequacy of protocol-specified surgical and endoscopic procedures (where relevant) through review of operative/procedures notes and study-specific surgical forms.
- Imaging: assessment of adequacy of protocol-specified imaging procedures. This includes (1) methods for acquisition and display of images; (2) methods for monitoring quality of image interpretation including quantitative measurement of lesions; and, (3) methods for data archiving and retrieval.
- Laboratory: For correlative studies, quality assurance procedures for the laboratory assays shall be instituted.
