Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Plasma and serum for biobanking will be collected in a fasted state at visit 2 and the end of treatment in both trials and at visit 7 in the 1366.0021 trial. All BI internal and external facilities storing biological samples from patients will be qualified for the storage of clinical biological samples. An appropriate sample and data management system is in place, including an audit trail for clinical data and samples to identify and destroy such samples according to the informed consent. Detailed instructions on sampling, preparation, processing, shipment and storage will be provided to investigators in the central laboratory manual. There is no genetic element to the biobanking planned in these trials.