
==== Front
Res Sq
ResearchSquare
Research Square
American Journal Experts

10.21203/rs.3.rs-4414917/v1
10.21203/rs.3.rs-4414917
preprint
1
Article
Improving eSource Site Start-Up Practices
Cramer Amy E.
King Linda S.
Buckley Michael T.
Casteleyn Peter
Ennis Cory
Hamidi Muayad
Rodrigues Gonçalo M. C.
Snyder Denise C.
Vattikola Aruna
Eisenstein Eric L.
24 5 2024
rs.3.rs-4414917https://creativecommons.org/licenses/by/4.0/ This work is licensed under a Creative Commons Attribution 4.0 International License, which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use.
https://www.researchsquare.com/article/rs-4414917/v1
nihpp-rs4414917v1.pdf
Abstract

Background: eSource software that copies patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. Integrating eSource into multicenter clinical trial start-up procedures could facilitate the use of eSource technologies in clinical trials. Methods: We conducted a qualitative integrative analysis to identify eSource site start-up key steps, challenges that might occur in executing those steps, and potential solutions to those challenges. We then conducted a value analysis to determine the challenges and solutions with the greatest impacts for eSource implementation teams. Results: There were 16 workshop participants: 10 pharmaceutical sponsor, 3 academic site, and 1 eSource vendor representatives. Participants identified 36 Site Start-Up Key Steps, 11 Site Start-Up Challenges, and 14 Site Start-Up Solutions for eSource-enabled studies. Participants also identified 77 potential impacts of the Challenges upon the Site Start-Up Key Steps and 70 ways in which the Solutions might impact Site Start-Up Challenges. The most important Challenges were: (1) not being able to identify a site eSource champion and (2) not agreeing on an eSource approach. The most important Solutions were: (1) vendors accepting electronic data in the FHIR standard, (2) creating standard content for eSource-related legal documents, and (3) creating a common eSource site readiness checklist. Conclusions: Site start-up for eSource-enabled multi-center clinical trials is a complex socio-technical problem. This study’s Start-Up Solutions provide a basic infrastructure for scalable eSource implementation.
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