Literaturnachweis - Detailanzeige
Autor/inn/en | Shafiq, Nusrat; Kumari, Savita; Kumar, Vivek; Suri, Vinita; Jayashree, Muralidharan; Duseja, Ajay; Bansal, Arun; Malhotra, Samir |
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Titel | On-Site Monitoring of Clinical Trials by an Ethics Committee in India: A Road Less Travelled |
Quelle | In: Research Ethics, 17 (2021) 1, S.45-54 (10 Seiten)Infoseite zur Zeitschrift
PDF als Volltext |
Zusatzinformation | ORCID (Malhotra, Samir) |
Sprache | englisch |
Dokumenttyp | gedruckt; online; Zeitschriftenaufsatz |
ISSN | 1747-0161 |
DOI | 10.1177/1747016120933923 |
Schlagwörter | Ethics; Medical Research; Outcomes of Treatment; Foreign Countries; Advisory Committees; Compliance (Legal); Informed Consent; Research Problems; Health Insurance; Supervision; Patients; Guidelines; Recordkeeping; Storage; Drug Therapy; Laws; Compensation (Remuneration); India |
Abstract | 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. (As Provided). |
Anmerkungen | SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: http://sagepub.com |
Erfasst von | ERIC (Education Resources Information Center), Washington, DC |
Update | 2024/1/01 |