Compliance challenges in clinical research organizations


J. Pharm. Pharmacogn. Res., vol. 12, no. 1, pp. 91-98, Jan-Feb 2024. DOI: Original Article Compliance challenges in clinical research organizations: A USFDA inspection retrospective [Desafíos de cumplimiento en organizaciones de investigación clínica: Una retrospectiva de inspección de la USFDA] T. Sudheer Kumar, Raju Kamaraj* Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM … Continue reading Compliance challenges in clinical research organizations

J. Pharm. Pharmacogn. Res., vol. 12, no. 1, pp. 91-98, Jan-Feb 2024.


Original Article

Compliance challenges in clinical research organizations: A USFDA inspection retrospective

[Desafíos de cumplimiento en organizaciones de investigación clínica: Una retrospectiva de inspección de la USFDA]

T. Sudheer Kumar, Raju Kamaraj*

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu -603203, India.



Context: Clinical research plays a vital role in advancing medical knowledge and improving patient care. As regulatory bodies strive to ensure the integrity and safety of clinical trials, the US Food and Drug Administration (USFDA) conducts inspections to evaluate compliance with established regulations.

Aims: To examine the USFDA’s inspections and non-compliance actions taken against clinical research organizations (CROs) over a 13 years period.

Methods: The study utilizes a comprehensive dataset compiled from publicly available records, including inspection reports, warning letters, and other regulatory documents issued by the USFDA. Through systematic data collection and analysis, this study seeks to shed light on the frequency and nature of non-compliance findings, identify common areas of concern, and evaluate the effectiveness of regulatory actions.

Results: The study reveals patterns and trends in the USFDA’s inspections, highlighting key compliance challenges faced by CROs. These challenges include issues related to study protocols, informed consent, data integrity, adverse event reporting, and adherence to good clinical practice (GCP) guidelines. Furthermore, this analysis explores the USFDA’s warning letters to assess their impact on CROs’ compliance efforts.

Conclusions: The findings of this retrospective analysis can inform CROs, and other stakeholders about the areas of greatest concern in clinical research compliance. The study contributes to the ongoing efforts to enhance the quality and integrity of clinical trials, ultimately benefiting patient safety and the credibility of the research enterprise.

Keywords: compliance; ethics; research; safety; USFDA.



Contexto: La investigación clínica juega un papel vital en el avance del conocimiento médico y la mejora de la atención al paciente. A medida que los organismos reguladores se esfuerzan por garantizar la integridad y la seguridad de los ensayos clínicos, la Administración de Alimentos y Medicamentos de EE. UU. (USFDA) realiza inspecciones para evaluar el cumplimiento de las reglamentaciones establecidas.

Objetivos: Examinar las inspecciones de la USFDA y las acciones de incumplimiento tomadas contra las organizaciones de investigación clínica (CRO) durante un período de 13 años.

Métodos: El estudio utiliza un conjunto completo de datos compilados a partir de registros disponibles públicamente, incluidos informes de inspección, cartas de advertencia y otros documentos reglamentarios emitidos por la USFDA. A través de la recopilación y el análisis sistemáticos de datos, este estudio busca arrojar luz sobre la frecuencia y la naturaleza de los hallazgos de incumplimiento, identificar áreas comunes de preocupación y evaluar la efectividad de las acciones regulatorias.

Resultados: El estudio revela patrones y tendencias en las inspecciones de la USFDA, destacando los principales desafíos de cumplimiento que enfrentan las CRO. Estos desafíos incluyen cuestiones relacionadas con los protocolos de estudio, el consentimiento informado, la integridad de los datos, la notificación de eventos adversos y el cumplimiento de las pautas de buenas prácticas clínicas (BPC). Además, este análisis explora las cartas de advertencia de la USFDA para evaluar su impacto en los esfuerzos de cumplimiento de las CRO.

Conclusiones: Los hallazgos de este análisis retrospectivo pueden informar a las CRO y otras partes interesadas sobre las áreas de mayor preocupación en el cumplimiento de la investigación clínica. El estudio contribuye a los esfuerzos en curso para mejorar la calidad y la integridad de los ensayos clínicos, lo que en última instancia beneficia la seguridad del paciente y la credibilidad de la empresa de investigación.

Palabras Clave: cumplimiento; ética; FDA; investigación; seguridad.

Citation Format: Sudheer Kumar T, Kamaraj Raju (2024) Compliance challenges in clinical research organizations: A USFDA inspection retrospective. J Pharm Pharmacogn Res 12(1): 91–98.

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