ArticlePerspectives in clinical research
Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital.Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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