Remote source document verification in two national clinical trials networks: a pilot study

• Published in: PloS one Vol. 8; no. 12; p. e81890
• Main Authors: Mealer, Meredith, Kittelson, John, Thompson, B Taylor, Wheeler, Arthur P, Magee, John C, Sokol, Ronald J, Moss, Marc, Kahn, Michael G
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 05.12.2013; Public Library of Science (PLoS)
• Subjects: Access control; Accountability; Accuracy; Adult; Child; Clinical medicine; Clinical trials; Clinical Trials as Topic; Comparative analysis; Corporate sponsorship; Cost control; Costs; Critical care; Design; Documentation; Electronic health records; Electronic Health Records - standards; Feasibility studies; Forms and Records Control - methods; Human subjects; Humans; Informatics; Medical research; Medicine; Monitors; Onsite; Pediatrics; Pilot Projects; Policies; Quality; R&D; Randomization; Records; Regulatory compliance; Remote monitoring; Remote searching; Research & development; Statistical analysis; Studies; United States; Validity; United States > US; Colorado; Massachusetts
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0081890

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. 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. 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. 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.