Source data verification – it can be a short story and not a novel!
Posted by: Joe Martinez, RPh, PDE, PPC
We’ve all been there before if you’ve been doing clinical trials for some time: the protocol is approved, patients are recruited and enrolled, clinical sites engage and monitor their patients and then the happy day of the last patient visit. However, don’t pop the bubbly just yet because the database needs to be locked and that means the joys of source data verification have just begun…please read on.
Source Data Verification (SDV) is a necessary component of every clinical trial. Source documents are used to achieve two explicit regulatory objectives: to document the existence of the patients/subjects and to validate the integrity of trial data.
True eSource is one way to expedite the process while maintaining the highest quality standards.
TransCelerate defines source data verification as “the process by which data within the case report form (CRF) or other data collection systems are compared to the original source of information (and vice versa).” When we look at where clinical monitors spend their time, you’ll see that almost half (an average of 46%) of their time is spent dealing with SDV .
In addition and according to accepted industry sources, approximately 97% of the clinical data entered into an EDC system is accurate and clean. So how do we quickly and compliantly ‘clean and verify’ the other 3%? The answer: by implementing and using eSource.
A lot of energy, time and costs are eaten up in this process and some estimate up to 40% of clinical trial costs can be spent on the SDV process alone. With eSource there are a limited number of source documents that must be examined and verified and much can be done in real-time to minimize the number of outliers and alerts.
The use of technology has enabled many innovations and evolutions in how we implement and execute clinical trials. The meaningful use of technology will enable us to keep moving forward, driving drug development and ultimately providing all patients with more and better therapy options.
Case StudyA Biopharmaceutical Company Sponsoring a Phase II Clinical Trial in the U.S.
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