Current Edition

Medical Management in Clinical Trials: A Roadmap to Operational Excellence (Part 4 – Close-out Phase)

Being the final feature of this four-part series of medical
management of clinical trials, Mohamed El Malt, MD,PhD,
Vijayanand Rajendran, MD and Kelechi K. Olu MD, MSc.
At Europital in this article will focus on the medical activities
during the close-out phase of a clinical study. 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.