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Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 20 3868 9735

Karthikeyan Kumar

Clinical Trial Manager, Clinical Operations, Global CRO, Chennai, India

Publications
  • Research Article   
    A South East Asia Multi-Country Survey Assessing Awareness and Preparedness of the Clinical Investigation Staff on Risk Based Monitoring (RBM) Approach
    Author(s): Karthikeyan Kumar* and Manoj P Jadhav

    Background: Patient safety being paramount, the global agencies (US-FDA, EMA, MHRA, ICH) have developed various guidance to improve clinical trials quality, conduct, performance and assess these on risk based principles. Among these, Risk Based Monitoring (RBM) has gained a considerable traction globally to be implemented across all phases of clinical trials. Methods: A multi-type survey questionnaire containing 19 elements was developed, validated, and circulated among clinical trial staff, between July 2016-June 2017. The survey consisted questions pertaining to responder’s sex, role, trial experience in past 5 years, utilization of RBM tools, type of trials involved in RBM, opinion on better type of monitoring, timely oversight of trial data by RBM, implications of RBM in subject’s safety, data quality, overall efficiency, cos.. Read More»
    DOI: 10.35248/2167-0870.20.10.413

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