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Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study

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  • Meredith Mealer
  • John Kittelson
  • B Taylor Thompson
  • Arthur P Wheeler
  • John C Magee
  • Ronald J Sokol
  • Marc Moss
  • Michael G Kahn

Abstract

Objective: Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible. Methods: Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected. Results: Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV. Conclusions: Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.

Suggested Citation

  • Meredith Mealer & John Kittelson & B Taylor Thompson & Arthur P Wheeler & John C Magee & Ronald J Sokol & Marc Moss & Michael G Kahn, 2013. "Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study," PLOS ONE, Public Library of Science, vol. 8(12), pages 1-1, December.
    • Handle: RePEc:plo:pone00:0081890
    DOI: 10.1371/journal.pone.0081890
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    References listed on IDEAS

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    1. Meredith L Nahm & Carl F Pieper & Maureen M Cunningham, 2008. "Quantifying Data Quality for Clinical Trials Using Electronic Data Capture," PLOS ONE, Public Library of Science, vol. 3(8), pages 1-8, August.
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