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2023-05-29T04:25:58
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The investigator shall provide information to the clinical investigation subject through informed consent proc

The investigator shall provide information to the clinical investigation subject through informed consent process as provided in Table 8 about the essential elements of the clinical investigation and the subject's right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/her nominee(s) of their rights to contact the sponsor or his representative whosoever had obtained permission from the Central Licensing Authority for conduct of the clinical investigation for making claims in case of investigation related injury or death. (4) Responsibilities of the Ethics Committee: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the study. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 167 of 248 Explanation : The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners, armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics Committee(s) get documented 'standard operating procedures' and should maintain a record of its proceedings. (ii) 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.

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