Science Driven CRO

Science Driven CRO


Medical Management In Clinical Trials (04): A Roadmap To Operational Excellence Part 4: Close-Out Phase

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Medical Management In Clinical Trials. Part 4: Close-Out Phase 

2016 started as a promising year with many exciting projects with which Europital medical experts would be able to accomplish two of their principal endeavors: knowledge building and information sharing. As a result, during this period a large number of scientific articles have been published in diverse international Journals within the industry.

This article forms the final feature of the four-part series of medical management of clinical trials, in which the various medical activities during the close-out phase of a clinical study are discussed:

“The close-out phase here refers to the period from last patient out (LPO) till the issuing of the final clinical study report (CSR). As the study conduct operations come towards a conclusion, the routine medical monitoring activities give way to the intense data cleaning, data review and reports development phase. This same set of activities will also be carried out in the event that interim analyses need to be performed at predefined time points of the study. This last phase holds major significance as patient data from the study will be extracted, organised, evaluated and formulated in the CSR, in order to provide a comprehensive presentation of the study results. Insight from the medical monitor (MM) is needed at this critical juncture to generate evaluable data, and to structure the data presentation in such a way as to support the assessment of study objectives“

We invite you to read the entire article (pages 24-27) in the Journal for Clinical Studies by clicking the cover image.