preview

Essay On Good Clinical Practice Auditing

Decent Essays

Last minute preparation task for sponsor’s audit can arise at any time when there is a notice form of an impending inspection. The research site will be notified and the sponsor may be sked about additional information concerning specific sites. Although the inspection may happen after the study is complete and the marketing application had been submitted. It is important that the site to consider the possibility of such inspection and auditing at any time during the conduction of the study.
The best preparation for Good Clinical Practice inspection and auditing starts before the onset of the study by ensuring that all the required regulatory documents and all activities that will be conducted at the site are according to the protocol and …show more content…

Usually the monitor will be one who is familial with the trial to assure all documents is complete and in compliance with the protocol and regulatory requirements. The monitor/CRA should be accompanied by a clinical quality assurance representative whose task will be to instruct the site on who to prepare for and best manage the upcoming inspection.
I will not be angry rather than, I will be relieved, and I will appreciate that the sponsor is giving the site the best possible opportunity to organize and prepare for the inspection. Although, the principle investigator is responsible for assuring adequate and accurate records at the site, however, having a representative from the sponsor and a quality assurance team visiting the site before the inspection will help the research team to present the site and the data to the inspector in the best possible way.
The visit by the inspector is more critical to the success of the clinical trial. The visit by the sponsor representative is to ensure that the site is ready for inspection by the regulatory agency, while the visit by the inspector and the review of data by a regulatory agency may be the final stage that may lead to approval of a marketing

Get Access