Description
Template is for submission of a streamlined Study Risk Determination to the IND by Biopharma when CLIA LDTs are being used for clinical trial eligibility. Includes regulatory expectations for immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR)-based CLIA LDTs. Boudicca Dx. LLC can support completion of this template if needed.
