eSource – Meeting Regulatory Expectations

May 10, 2017

eSource is the term used to denote data that are  generated or captured directly from digital sources such as instrumentation or electronic health records or that are acquired by other electronic means, including transcription by an operator from any source documents, including but not limited to paper documents.

Both FDA and EMA have issued detailed guidance with respect to the application of GCP-ICH regulations to eSource data. Over time the expectations regulators bring to the inspection and assessment of eSource data have evolved based both on the maturing of technology and their inspection experience encountering eSource data and the computerized systems that use eSource in the conduct of clinical trials.

Knowing and correctly applying the regulators’ inspection perspective is vital to a successful inspection readiness program and vital to achieving confidence in the integrity of the clinical data itself.

Strategies such as implementing a program of Data Stewardship, meaningful audit trail reviews, documented risk-based validation, can help you create an appropriate, confident, and defensible constellation of quality processes, documents, test evidence, procedural checks, and operational procedures that will not only withstand inspection scrutiny but also give you and the patients you serve the highest confidence on the integrity of your data and results.