alexa Multicentre Clinical Trial Monitoring
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

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Research Article

Multicentre Clinical Trial Monitoring

Tamilselvi Srinivas* and Angankari Srinivas
Quest Life Sciences Pvt Ltd, SDF III, MEPZ, Tambaram, Chennai, India
Corresponding Author : Tamilselvi Srinivas
Quest Life Sciences Pvt Ltd
SDF III, MEPZ, Tambaram
Chennai 600 045, India
E-mail: [email protected], [email protected]
Received October 03, 2012; Accepted October 19, 2012; Published October 21, 2012
Citation: Srinivas T, Srinivas A (2012) Multicentre Clinical Trial Monitoring. Pharmaceut Reg Affairs S12:002. doi: 10.4172/2167-7689.S12-002
Copyright: © 2012 Srinivas T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 

Abstract

A standard quality control plan was established to monitor the quality conductance at Multicentre trials. Case report forms were designed; qualified investigators, and study personnel were trained on given protocol. Monitoring personnel who appointed for the trial has experience with monitoring program. It ensures overall guaranteed data accuracy and to prevent or to identify protocol deviations/violations. Clinical site, physicians and study personnel were audited, and the study conductance processes were audited as well. In addition, the forms of the case reports are reviewed for completeness and internal consistency. The eligibility and validity of the patients was verified in this study, and the data was monitored for compliance and accuracy. Supplementing and improving the existed procedures for quality monitoring will ensure that multi-centre clinical trials are considered as valid and scientifically stringent. This paper provides practical approach for implementing strict monitoring plan for randomized controlled trials (RCTs).

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