Plans for assessment and collection of outcomes {18a}
CRF
CRF
Patient assessment source data will be managed following Good Clinical Practice (GCP) guidelines using an FDA-conforming database with an audit trail and internal monitoring provided by the coordinating center. Participating centers will submit data using electronic case report forms (eCRF). The name, day of the month, and month of birth of participants will not be stored electronically, participant data records will be identified with identifier unique to each participant. Corresponding personal data will be maintained in paper format by each participating center and with a copy (via fax) of forms containing the participant’s name and contact data (such as consent forms) transmitted to the coordinating center. All paper data will be maintained in a locked room and locked cabinet. The informed consent process is documented in the patient records. The original signed documents will be part of the investigator’s site file and retained with it and one copy included the insurance policy of the trial will be handed to the patient. All procedures administered to the subjects on entry to the trial or at any time during the trial will be documented paper-based in a pseudonymous manner. At the end of each visit, the data will be entered into The Clinical Data Management System [“secuTrial”], which will be used for data capture, processing and storage of study data. The paper-based documentation will be stored in a lockable cabinet at the investigational site, not-accessible to non-authorized personnel. Data entry is performed access-controlled at the investigational site by clinical staff after having received training and a user manual for the electronic CRF. Raw biosignal data will be uploaded to a secure cloud server at the coordinating center for quality control and analysis. Various EEG and EMG measures (spectral analysis, signal-to-noise ratio, motor evoked response amplitudes, etc.) will be extracted by the coordinating center and stored in the trial database.