Clinical investigation team Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/designates, Central laboratory etc.). 7. Results The results should include the following points:— (a) the clinical investigation initiation date; (b) the clinical investigation completion/ suspension date; (c) the disposal of subjects and investigational medical devices; (d) the subject demographics; (e) clinical investigation plan compliance; (f) an analysis, which includes, — (i) a performance analysis as provided in the clinical investigation plan; (ii) a summary of all adverse events and adverse device effects, including a discussion of the severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal relationship with the investigational medical devices or procedure;