Year : 2022 | Volume
: 13 | Issue : 4 | Page : 189--193
Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital
Ganesh Nathuji Dakhale1, Mrunalini Vinay Kalikar2, Akhil B Giradkar2, Vishakha V Sinha2
1 Department of Pharmacology, AIIMS, Nagpur, Maharashtra, India
2 Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India
Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders.
Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed.
Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation.
Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.
Dr. Mrunalini Vinay Kalikar
Department of Pharmacology, Government Medical College, Nagpur, Maharashtra
|How to cite this article:|
Dakhale GN, Kalikar MV, Giradkar AB, Sinha VV. Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.Perspect Clin Res 2022;13:189-193
|How to cite this URL:|
Dakhale GN, Kalikar MV, Giradkar AB, Sinha VV. Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital. Perspect Clin Res [serial online] 2022 [cited 2022 Dec 6 ];13:189-193
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2022;volume=13;issue=4;spage=189;epage=193;aulast=Dakhale;type=0