Clinical Investigation for Medical Device

The Clinical Investigation Plan (CIP) is the key document in medical device clinical investigations that state(s) the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation. The CIP shall specifically address what medical care, if any, will be provided for the subjects after the clinical investigation has been completed (if applicable)

The Clinical investigation should be carried out by the Clinical investigator, who is generally a doctor. The sponsors or medical device manufacturers should liaison with the Hospital or clinic where the Clinical investigator is associated. Before liaising, the Ethical committee or Institutional Review Board (IRB) should approve the clinical trials.

Investigators must send progress reports, safety reports, and financial disclosures to the sponsor at least annually during the trial, and a final report is due at the end of the trial. Serious adverse events—unexpected events that are severe or life-threatening—must be reported immediately, but non serious adverse events can be reported according to the timetable for reporting specified in the protocol.