It’s time for a review on standard operating procedures or Medical Review SOP compliance framework. Clinical operations depend on how well each clinic adheres to a prescribed way of functionality. The SOP lays out an official list of parameters that answer the important questions: what, where, why, how, and who?
Where clinical research is concerned, uniformity of the performance of a specific function laid out in the Medical Review SOP is paramount to running a clinic in accordance with Federal Regulations, Good Clinical Practice (GCP), and Institution Review Board (IRB) policies. The detailed instruction set out to be written in a way that supports responsible, operational service.
Departmental directors and/or leaders usually work with quality management experts within conduct meetings where they oversee the establishment of the standard operating procedures. It’s a good idea to review these protocols annually as a way to fill in compliance gaps that organizations are unable to rectify during busier times. Then, there’s the FDA Bioresearch Monitoring Guidance for Sponsors who also has a say in how these inspections should be conducted.
The governmental guidance board states that these inspections ought to cover and “evaluate the sponsor’s/CRO’s/monitor’s practices and procedures to determine compliance with applicable regulations.” If updates have to made, this main point is kept in mind as the primary measurement of a successful investigation. Then, teams should consider new technology and information gleaned from new methodologies in the research itself.
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