Tamilselvi Srinivas and Ankanagari Srinivas
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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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
