Data collection
CRF
CRF
Clinical data required by the protocol were entered into the electronic case report forms (eCRFs) and used a fully validated secure web-enabled electronic data capture (EDC) system, Medidata Classic Rave 2022.3.2, which is compliant with 21 CRF Part 11 requirements. Automatic validation edit checks in the EDC system and offline listings were programmed to capture data discrepancies in the eCRFs and allowed modification and validation of the entered data. The investigator verified and signed off the eCRFs in the EDC system to confirm that the clinical data captured were complete and accurate. The sponsor can attest that all data and metadata will be archived in perpetuity. The data are in the EDC system and the trial master file (TMF), which are retained in perpetuity. In addition, these data have been filed with the US FDA.