On-site monitoring of clinical trials by an Ethics Committee in India
A road less travelled
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Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees
Adverse effect · Alternative medicine · Clinical research · Clinical trial · Data monitoring committee · Ethics committee · Family medicine · Good clinical practice · Health care · Informed consent · Pathology · Political science · Psychiatry · Reimbursement · Research ethics · Biomedical Ethics and Regulation · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Law · Medicine · Public Administration · Internal Medicine
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| Obras citantes distintas | 2 |
|---|---|
| Citas por año | 0,5 |
| Intervalo de citas | 2022 - 2023 (2) |
| Velocidad de citación | historical |
| Altamente citado | No |
| Tipos de cita | Neutras: 2 |