Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation of the Clinical Investigation Plan. Such review may be based on periodic study progress reports furnished by investigators or monitoring and internal audit reports furnished by the sponsor. (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record the reasons for doing so and at once, communicate such a decision to the investigator as well as to the Central Licensing Authority. (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis, shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the Head of Institution where the clinical investigation has been conducted within 14 calendar days of the knowledge of occurrence of the serious adverse event.