![]() ![]() ![]() Contracts and agreements were missing with key vendors or lacked detail.Trial Master File ( TMF) / Investigator Site File ( ISF) audit were the only types of audits performed and the QA Manager lacked experience in performing audits.The Quality Management System ( QMS) lacked key procedures required to ensure oversight of trials and there was no assessment of the CTU´s QMS for those trials managed by the CTU.The following critical finding was observed in case of a sponsor due to lack of oversight of trials managed by the Clinical Trial Unit ( CTU) and Chief Investigators ( CI) which resulted in critical compliance issues with pharmacovigilance in one of the sponsored trials: The blog states: " It would appear that compliance is improving in this area, but many factors can influence these metrics such as the total number and types of inspections performed during the year".Īdditionally, two case studies have been presented: ![]() More recently, during the period 2016- 2017 there was one critical finding for ‘Organization’s Oversight of Clinical Trials’ which was identified at a non-commercial organization and two major findings (one each at commercial and non-commercial organizations). During the period before twelve major findings were observed (six each at commercial and non-commercial organizations). A total of ten major findings were found (nine at non-commercial organizations and one at a commercial organization). Recently, the MHRA posted Part 2 of the blog which provides some metrics together with two case studies from recent GCP inspections in regard to Organization’s Oversight of Clinical Trials.Īccording to the agency, during the period of 2015 - 2016 three critical findings were observed (all at non-commercial organizations). Thus, mechanisms should be in place to demonstrate oversight of activities contracted or delegated to ensure patient safety and data integrity. The Sponsor maintains overall responsibility for the conduct and reporting of the trial. In our previous News about the MHRA blog on Sponsor Oversight we reported on the different mechanisms by which oversight can be demonstrated. GMP Courses & Conferences on Site (in hotels). ![]()
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