Source Data Verification Essay

Technology is changing the way our society accesses information and communicates; no doubt the future of clinical research will be shaped by these changes. One such example is the need for source data verification (SDV). The process of SDV begins with the patient and the information captured by the clinician into a document (mostly on paper) which someone manually transcribes into a computer database to send to the sponsor. The CRA reads this source, usually in person, and verifies the data points in the database. But what if there was no difference between the source and the EDC? This would allow the CRA to focus on his most important role: to ensure the safety and ethical treatment of study subjects participating in clinical trials. The review of the source documents for consistencies, source data review, is more effective at capturing safety concerns than SDV. With …show more content…
A tablet computer with a stylus could be used by the clinician to capture handwritten data as he would with paper source. Through handwriting recognition or even voice recognition, this data could be captured in a central database to be verified by the CRA remotely, essentially having electronic access to the complete site source.
Technology can also be used to create an electronic trial master filing system (eTMF) that the site can use to eliminate the need for paper regulatory binders. This again would free up time for the CRA to focus on safety and data integrity. Review of the eTMF remotely by the CRA or other designated persons would save considerable time and allow monitoring visits to be more focused. The monitoring visit itself could further be refined in scope using a data-based computer algorithm identifying data points and sites at the highest risk for inconsistencies, known as risk based