An Open Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials - Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium
Björn Koneswarakantha,
Ronojit Adyanthaya,
Jennifer Emerson
et al.
Abstract:Accurate and timely reporting of adverse events (AE) in clinical trials is crucial to ensuring data integrity and patient safety. However, AE under-reporting remains a challenge, often highlighted in Good Clinical Practice (GCP) audits and inspections. Traditional detection methods, such as on-site investigator audits via manual source data verification (SDV), have limitations. Addressing this, the open-source R package {simaerep} was developed to facilitate rapid, comprehensive, and near-real-time detection o… Show more
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