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

Accurate and timely reporting of adverse events (AEs) 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...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Therapeutic innovation & regulatory science 2024-07, Vol.58 (4), p.591-599
Hauptverfasser:	Koneswarakantha, Björn, Adyanthaya, Ronojit, Emerson, Jennifer, Collin, Frederik, Keller, Annett, Mattheus, Michaela, Spyroglou, Ioannis, Donevska, Sandra, Ménard, Timothé
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse Drug Reaction Reporting Systems - standards Adverse events Analytical Report Clinical trials Clinical Trials as Topic Consortia Drug Safety and Pharmacovigilance Drug-Related Side Effects and Adverse Reactions Heuristic methods Humans Impalas Medicine Pharmacotherapy Pharmacy Software
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!