Technological Adjuncts to Streamline Clinical Research Processes: Recruitment, Informed Consent, and Data Management (Preprint)

Abstract

<sec> <title>BACKGROUND</title> Patient recruitment and data management are laborious, resource-intensive aspects of clinical research that often dictate whether the successful completion of studies is possible. Technological advances present opportunities for streamlining these processes, thus improving completion rates for clinical research studies. </sec> <sec> <title>OBJECTIVE</title> This paper aims to demonstrate how technological adjuncts can enhance clinical research processes via automation and digital integration. </sec> <sec> <title>METHODS</title> Using one clinical research study as an example, we highlight the use of technologic adjuncts to automate and streamline research processes across various digital platforms, including an enterprise data warehouse (EDW), a clinical research data management tool (REDCap), and a locally managed, HIPAA-compliant server. Eligible participants are identified through automated queries in the EDW, after which they receive personalized email invitations with digital consent forms. After digital consent, patient data is transferred to a single HIPAA-compliant server where each participant is assigned a unique QR code to facilitate data collection and integration. After the research study visit, data obtained is associated with existing EMR data for each participant via a QR code system that collated participant consent, imaging data, and associated clinical data according to a unique exam ID. </sec> <sec> <title>RESULTS</title> Over a 19-month period, automated EDW queries identified 20,988 eligible patients, and 10,582 patients received personalized email invitations. 1000 patients (9.45%) signed consents to participate in the study. Of the consented patients, 549 unique patients completed 779 study visits; some patients consented to the study at more than one time period during their pregnancy. </sec> <sec> <title>CONCLUSIONS</title> Technological adjuncts in clinical research decrease human labor while increasing participant reach and minimizing disruptions to clinic operations. Automating portions of the clinical research process benefits clinical research efforts by expanding and optimizing participant reach while reducing the limitations of labor and time in completing research studies. </sec>

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