La « Society for Clinical Data Management (SCDM) » vient de publier le 12 juin 2014 le document « eSource Implementation in Clinical Research: A Data Management Perspective ».
Electronic technologies have redefined industries such as banking and commerce. Similarly, advances in technology are bringing massive changes to the healthcare realm, nearing a tipping point for overhauling every aspect of healthcare delivery and records management. As the paper chart is inevitably displaced in the daily practice of healthcare, it follows that the paper case report form (CRF) and paper site source documents for clinical research will also be displaced, ushering in the era of electronic source (eSource) for clinical studies. This transformation presents both opportunity and challenge for data management as we approach the intersection of the delivery of care and clinical research.
To achieve the full potential of eSource in clinical research, the process for data collection must be transformed from the traditional paper CRF collection model and associated paper site source documents to one that optimizes the availability of electronic data records while ensuring that data integrity and patient safety are not compromised. True transformation will preserve the requisite standards of conduct while reinventing the data collection process and governing regulations to fit the new electronic environment. This transformation is sure to surface many challenges—some real and some simply perceived.
The Society for Clinical Data Management (SCDM) has identified constructive principles and best practices for different modalities organized by process, people and technology to address these challenges. We present various data collection modalities of eSource and relevant considerations for successful implementation.
SCDM whitepaper – eSource Implementation in Clinical Research a Data Management Perspective – June 2014