An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.
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Date
2022-06
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Publisher
FORUM FOR MEDICAL ETHICS SOCIETY
Abstract
The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.
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Keywords
Investigational plan, informed consent, monitoring, documentation
Citation
Saxena U, Bose D, Saha S, Gogtay NJ, Thatte UM. An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.. Indian Journal of Medical Ethics. 2022 Jun; 7(2): 108-113