Sil Amrita, Das Nilay Kanti
Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Member of Institutional Ethics Committee, Institute of Neurosciences, Kolkata, West Bengal, India.
Indian J Dermatol. 2017 Jul-Aug;62(4):387-391. doi: 10.4103/ijd.IJD_273_17.
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.
临床试验相关损伤和严重不良事件（SAE）是一个主要关注领域。在所有此类情况下，研究者负责试验参与者的医疗护理，并且在伦理上有义务向临床试验的所有利益相关者报告该事件。试验申办者负责对研究产品进行持续的安全性评估，在发生任何严重不良事件时报告并补偿参与者。在这种情况下，该国的伦理委员会和监管机构应秉持有益、公正、无害的伦理原则。药物在推荐剂量下使用时的任何不良和有害作用都是药物不良反应（ADR），而如果因果关系尚未确定，则称为不良事件（AE）。与死亡、住院、住院时间延长、持续或严重残疾或无行为能力、先天性异常相关，或以其他方式危及生命的不良事件或药物不良反应称为严重不良事件。主要研究者在严重不良事件发生后24小时内将该事件报告给许可当局（药品总局）、申办者和伦理委员会（EC）主席。研究者和伦理委员会随后会提供一份详细报告，并提交给药品总局，然后由药品总局就申办者或申办者代表向受害方支付的赔偿金额做出最终决定。
