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PLoS One. 2013 Dec 5;8(12):e81890. doi: 10.1371/journal.pone.0081890. eCollection 2013.

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

Author information

1
Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
2
Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, United States of America ; Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz Medical Center, Aurora, Colorado, United States of America.
3
Massachusetts General Hospital, Biostatistics Center, Boston, Massachusetts, United States of America.
4
Vanderbilt University Medical Center, School of Medicine, Nashville, Tennessee, United States of America.
5
University of Michigan, Department of Surgery, Ann Arbor, Michigan, United States of America.
6
Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz Medical Center, Aurora, Colorado, United States of America ; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
7
Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, United States of America ; Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz Medical Center, Aurora, Colorado, United States of America.

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.

PMID:
24349149
PMCID:
PMC3857788
DOI:
10.1371/journal.pone.0081890
[Indexed for MEDLINE]
Free PMC Article

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