Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials.
For a number of compelling scientific, operational, and regulatory reasons, the use of electronic data capture is becoming the preferred means of collecting clinical outcome assessment (eg, patient-reported outcome [PRO]) data in clinical trials. Electronic PRO (ePRO) data collection leverages scree...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 49; no. 6; pp. 797 - 805 |
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| Main Authors: | , , , , |
| Format: | tables/charts Journal Article |
| Published: |
Springer Nature
Nov2015
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=110561731&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 110561731 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Nov2015 vid: 49 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 110561731 110561731 110561731 10.1177/2168479015609102 110561731 ppf: 797 ppct: 8 formats: tig: atl: Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials. aug: au: Fleming, Sarah Barsdorf, Alexandra I. Howry, Cindy O’Gorman, Hannah Coons, Stephen Joel affil: Patient Reported Outcomes, Janssen Global Services, Titusville, NJ, USA sug: subj: Clinical Trials Outcome Assessment Computers and Computerization Patient Attitudes Data Collection Methods Technology Computers, Portable Computers, Hand-Held Telephone Research Subjects Data Management Health Personnel ab: For a number of compelling scientific, operational, and regulatory reasons, the use of electronic data capture is becoming the preferred means of collecting clinical outcome assessment (eg, patient-reported outcome [PRO]) data in clinical trials. Electronic PRO (ePRO) data collection leverages screen-based technologies (eg, handheld devices, tablet computers, and web-based systems) and telephone-based (eg, interactive voice response) systems. Data collection is routinely either site based (ie, clinical study site) or field based (eg, subject’s home, school, or workplace). While tablet computers are often used for site-based PRO data collection, handheld devices have become the mainstay for ePRO data capture in field-based settings. The data collection devices are usually provisioned to the sites or subjects by an ePRO system provider contracted by the clinical trial sponsor. With site-based data collection, study staff are responsible for ensuring subject compliance with the protocol-driven data collection procedures, whereas with field-based data collection, the subject is responsible for compliance with the data entry requirements and sites are accountable for remotely monitoring the data for compliance. In addition to site and subject compliance issues, technology-related factors must be anticipated in order to adhere to the electronic PRO data collection plan. The objective of this paper is to describe study site-, subject-, and technology-related factors that may lead to deviations from the planned electronic collection of PRO data (eg, defaulting to paper-based data collection) and to provide recommendations aimed at preventing potential problems or quickly resolving problems once they occur. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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