title: Implementing a low-cost web-based clinical trial management system for community studies: a case study.
abstract: BACKGROUND
  Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions.
  
  
  OBJECTIVE
  To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry.
  
  
  METHODS
  Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks.
  
  
  RESULTS
  An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center.
  
  
  CONCLUSIONS
  Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires.
  
  
  CONCLUSIONS
  New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.
authors.affiliation: Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Geyer
authors.forename: Kathleen
authors.initials: K
authors.lastname: Myers
authors.forename: Ann
authors.initials: A
authors.lastname: Vander Stoep
authors.forename: Carolyn
authors.initials: C
authors.lastname: McCarty
authors.forename: Nancy
authors.initials: N
authors.lastname: Palmer
authors.forename: Amy
authors.initials: A
authors.lastname: DeSalvo
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D002648:Child; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D003299:Cooperative Behavior; D003362:Cost-Benefit Analysis; D003625:Data Collection; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D006801:Humans; D020407:Internet / Q000191:economics / Q000458:organization & administration*; D015337:Multicenter Studies as Topic; D009315:National Institute of Mental Health (U.S.); D019982:Organizational Case Studies; D016730:Program Development / Q000191:economics / Q000379:methods*; D012107:Research Design; D012111:Residence Characteristics; D011795:Surveys and Questionnaires; D014481:United States