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[Preprint]. 2024 May 24:rs.3.rs-4414917.
doi: 10.21203/rs.3.rs-4414917/v1.

Improving eSource Site Start-Up Practices

Amy E Cramer  1 , Linda S King  2 , Michael T Buckley  3 , Peter Casteleyn  1 , Cory Ennis  4 , Muayad Hamidi  5 , Gonçalo M C Rodrigues  6 , Denise C Snyder  7 , Aruna Vattikola  8 , Eric L Eisenstein  9
Affiliations

Improving eSource Site Start-Up Practices

Amy E Cramer et al. Res Sq. .

Update in

  • Defining methods to improve eSource site start-up practices.
    Cramer AE, King LS, Buckley MT, Casteleyn P, Ennis C, Hamidi M, Rodrigues GMC, Snyder DC, Vattikola A, Eisenstein EL. Cramer AE, et al. Contemp Clin Trials Commun. 2024 Nov 14;42:101391. doi: 10.1016/j.conctc.2024.101391. eCollection 2024 Dec. Contemp Clin Trials Commun. 2024. PMID: 39651464 Free PMC article.

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.

Keywords: clinical research; clinical trial; eSource; electronic data capture; electronic health records; health information technology.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT Amy E. Cramer: Employment, Johnson & Johnson Innovative Medicine Linda S. King: Employment, Astellas Pharma Michael T. Buckley: Employment, Memorial Sloan Kettering Cancer Center Peter Casteleyn: Employment, Johnson & Johnson Innovative Medicine Cory Ennis: Employment: Duke University School of Medicine Muayad Hamidi: Employment: UT Health San Antonio Gonçalo M. C. Rodrigues: Employment, Janssen-Cilag Denise C. Snyder: Employment, Duke University School of Medicine Aruna Vattikola: Employment, Merck & Co Eric L. Eisenstein: I have nothing to declare Additional Declarations: Competing interest reported. Amy E. Cramer: Employment, Johnson & Johnson Innovative Medicine Linda S. King: Employment, Astellas Pharma Michael T. Buckley: Employment, Memorial Sloan Kettering Cancer Center Peter Casteleyn: Employment, Johnson & Johnson Innovative Medicine Cory Ennis: Employment: Duke University School of Medicine Muayad Hamidi: Employment: UT Health San Antonio Gonçalo M. C. Rodrigues: Employment, Janssen-Cilag Denise C. Snyder: Employment, Duke University School of Medicine Aruna Vattikola: Employment, Merck & Co Eric L. Eisenstein: I have nothing to declare

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