title: Remote source document verification in two national clinical trials networks: a pilot study.
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.
authors.affiliation: Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
authors.forename: Meredith
authors.initials: M
authors.lastname: Mealer
authors.affiliation: 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.
authors.forename: John
authors.initials: J
authors.lastname: Kittelson
authors.affiliation: Massachusetts General Hospital, Biostatistics Center, Boston, Massachusetts, United States of America.
authors.forename: B Taylor
authors.initials: BT
authors.lastname: Thompson
authors.affiliation: Vanderbilt University Medical Center, School of Medicine, Nashville, Tennessee, United States of America.
authors.forename: Arthur P
authors.initials: AP
authors.lastname: Wheeler
authors.affiliation: University of Michigan, Department of Surgery, Ann Arbor, Michigan, United States of America.
authors.forename: John C
authors.initials: JC
authors.lastname: Magee
authors.affiliation: 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.
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Sokol
authors.affiliation: 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.
authors.forename: Marc
authors.initials: M
authors.lastname: Moss
authors.affiliation: 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.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Kahn
mesh_terms: D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic; D004282:Documentation; D057286:Electronic Health Records / Q000592:standards*; D005568:Forms and Records Control / Q000379:methods*; D006801:Humans; D010865:Pilot Projects; D011996:Records; D014481:United States