2023-07-12T05:23:02
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;
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