Purdue University Mod 6 Clinical Trial Management Systems Discussion
There are many clinical trial management systems (CTMS) used in clinical trials. Some are developed on site or at the organization specifically to meet the needs of the organization. Some are purchased off shelf and are used as is. Others offered by various vendors can be purchased and the vendor will customize the software to meet the needs of the organization. 21 CFR 11 outlines the requirements of electronic data systems. For this discussion you will take the role of a quality manager at a study site who has been tasked with evaluating CTMS products and recommending one for your site. Based on your review of 21 CFR 11, what are two (2) questions you would ask of a vendor about their CTMS to ensure it is compliant with 21 CFR 11? Why would you ask these two questions?