Background of the eSource Readiness Assessment (eSRA) Project

An increasing number of healthcare institutions are employing Electronic Health Records (EHRs) to maintain patient records. Clinical research draws on a combination of data collected during the course of a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in EHRs, making them "eSource" for clinical research. Even if they are not used in their electronic state for clinical research, but are printed out from the EHRs and then re-entered into an EDC (Electronic Data Capture) system for a clinical trial, the source of the information must still be verified.

The source must still hold the integrity that other clinical trial source is held to via regulatory agency regulations and guidelines. The assessment tool asks questions based on the minimum requirements for source (of any type) for clinical research, based on regulations and regulatory agency guidelines.

This tool is based on previous eClinical Forum work in this arena, the "Electronic Health Records for Clinical Research (EHRCR) Functional Profile" which can be used by electronic health record vendors to qualify their systems for use in running clinical trials. The EHRCR is approved as an HL7 Standard, and ANSI Standard, and a EuroRec Profile.

More information on the EHRCR can be found at: EHRCR Functional Profile Project

While the EHRCR was targeted at healthcare system vendors, the eSRA Assessment tool is a natural progression from this work, enabling sites to easily and quickly show proof of integrity of data stored in their healthcare systems as well as identify work-arounds for areas for improvement.

That said, eSRA also provides a quick and easy way for healthcare system vendors to provide pre-fill information to their clients on the systems they use. This eSRA pre-fill information is further enhanced by eSRA mapping to existing healthcare system certifications that vendor systems may hold.

 

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