Effectiveness and Costs of Remote Monitoring for Clinical Trials

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Michigan
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01151995
First received: June 24, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

This pilot project will evaluate Internet-based remote access to electronic clinical systems to support study monitoring tasks. The project engages two NIH-sponsored clinical trial networks (adult: ARDS network; pediatrics: ChiLDREN network) at five trial locations and two coordinating centers located across four states, which engages three collaborating NCRR-funded CTSA institutions. Each study location uses different electronic clinical systems and remote access methods, replicating the diversity of clinical applications and access methods found across large research networks. The results of this pilot project will inform a broader project that will engage all trial sites with electronic clinical systems in both national networks.

This proposal extends Specific Aim 1.2 of the Research Informatics Integrated Core (RIIC) in the parent grant (UL1 RR025780) for the Colorado Clinical and Translational Sciences Institute (CCTSI): "The RIIC will develop and implement tools and services that will….(2) support the efficient execution of the CCTSI translational research projects." (CCTSI grant page 1053). Specific Aim 1.2 proposes to develop new informatics methods that increase the translational research capacity by improving the efficiency of executing clinical studies. Reducing barriers to study monitoring via remote access will enable new innovative approaches to protecting study subjects, ensuring study data quality and documenting regulatory compliance. An example of a completely new model for study monitoring could be continuous study monitoring from any coordinating center to any study location in the Internet-connected world.

We hypothesize that remote monitoring will demonstrate substantial improvements in study monitoring efficiency, effectiveness, and possibly overall costs when compared to present monitoring plans that require a prolonged on-site visit by a study monitor from the coordinating center. We do not claim that remote study monitoring will replace all monitoring tasks . But, for monitoring tasks that require access to electronic clinical data, we seek to demonstrate that remote access can enable more frequent SDV and regulatory documentation compliance, which in turn could facilitate new models of continuous study monitoring. The results of these studies would support improvements in study monitoring that would both significantly reduce the cost of conducting large multi-center clinical while improving the safety of those patients who are enrolled into these trials


Condition Intervention
Remote Monitoring
Other: Remote source document verification
Other: On-site source document verification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness and Costs of Remote Monitoring for Clinical Trials

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: 9/2011 ] [ Designated as safety issue: No ]
    Can remote source document verification replace on-site source document verification?

  • Efficiency and Cost [ Time Frame: 9/2011 ] [ Designated as safety issue: No ]
    Differences in time and costs


Biospecimen Description:

No biospecimens collected for this protocol


Estimated Enrollment: 20
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Remote plus on-site
Subjects will have remote source document verification performed 2-4 weeks prior to study monitors scheduled visit and any variables that were not able to be verified remotely will be verified on-site.
Other: Remote source document verification
Remote access to electronic medical records of the 5 participating sites
On-site monitoring
Traditional source document verification will be performed when study monitor is on site
Other: On-site source document verification
Study monitor will perform on-site source document verification during routine visit to the five participating sites

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population will be subjects who have already been enrolled in an ARDS or BARC/CLiC clinical trial network study.

Criteria

Inclusion Criteria:

  • Enrollment in the NIH-sponsored ARDS and BARC/CLiC clinical trial networks

Exclusion Criteria:

  • Not enrolled in the NIH-sponsored ARDS and BARC/CLiC clinical trials
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01151995

Locations
United States, Colorado
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Massachusetts General Hospital
University of Michigan
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01151995     History of Changes
Other Study ID Numbers: 09-0735
Study First Received: June 24, 2010
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Clinical Trial Monitoring
Effectiveness of remote monitoring
Efficiency of remote monitoring
Costs of remote monitoring

ClinicalTrials.gov processed this record on August 26, 2014