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IJD SYMPOSIUM
Year : 2017  |  Volume : 62  |  Issue : 4  |  Page : 387-391

Ethics of safety reporting of a clinical trial


1 Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal; Member of Institutional Ethics Committee, Institute of Neurosciences, Kolkata, West Bengal; Member of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology, India
2 Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal; Member of Institutional Ethics Committee of Human Research, Medical College, Kolkata, West Bengal; Coordinator of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology, India

Correspondence Address:
Amrita Sil
Department of Pharmacology, UCM Building, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijd.IJD_273_17

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Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR) whereas if causal association is not yet established it is termed adverse event (AE). An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI), sponsor and Chairperson of the Ethics Committee (EC) within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.


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