DOI: http://dx.doi.org/10.18203/2349-3259.ijct20160473

Barriers, adoption, technology, impact and benefits of risk based monitoring

Bharat Kumar Shukla, Mohammed Saleem Khan, Veerabhadra Nayak

Abstract


The expense and unpredictability of clinical trials have increased drastically as of late. Up to third of a clinical trials expense can now be credited to the customary on location audit of trial information. While powerful observing is basic to ensuring the prosperity of trial members and keeping up the respectability of definite results, it is presently by and large acknowledged that the procedure for clinical trial checking needs to change. A more brought together, hazard based methodology is currently the favoured technique for monitoring clinical trials, as per a few administrative offices, including the US Food and Drug Administration (FDA). The movement has demonstrated overwhelming to numerous associations, nonetheless, and it is now and again not clear where to start. Over the previous decade, the clinical research industry's standard to meet regulators monitoring commitments has included continuous and normal onsite monitoring visits with 100% source information confirmation (SDV). The conviction that "more is better" proceeds with new proof that onsite monitoring practices don't inexorably ensure persistent wellbeing and data quality.

Keywords


Risk based monitoring, Source document verification, Targeted monitoring, Triggered monitoring, USFDA, MHRA, EMEA, Triggers

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References


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