Why eSource Ensures Data Integrity In Medical Device Clinical Trials

By Rod McGlashing, Subject Matter Expert, Data Science and Tina Caruana, Subject Matter Expert of eClinical Solutions at Medrio

In the past, clinical trials heavily relied on paper-based source data. However, this landscape is evolving with the increasing adoption of electronic source (eSource) data capture methods. Traditionally, paper documents such as consent forms, case report forms (3-part NCR), site worksheets, lab reports, questionnaires, and diaries were the primary components of clinical trials. These documents were distributed, completed, reviewed, monitored, and stored manually.

Nowadays, the scope of source data has expanded into the electronic realm, where tools like eConsent, eCRFs, and ePRO are introducing innovative perspectives. In the context of medical device trials, this type of comprehensive data verification is crucial for ensuring safety, maintaining data integrity, and adhering to regulatory requirements. Manual source data verification (SDV) has been a standard practice for years, involving meticulous comparison of data entered into an electronic data capture (EDC) system against its corresponding paper source.

However, with the growing complexity of trials, eSource data capture offers a more efficient and cost-effective approach to maintaining data integrity. Explore the reasons behind this shift by accessing the full article below.