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Effectiveness and Costs of Remote Monitoring for Clinical Trials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01151995
First Posted: June 29, 2010
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
University of Michigan
Information provided by (Responsible Party):
University of Colorado, Denver
  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 ]
    Can remote source document verification replace on-site source document verification?

  • Efficiency and Cost [ Time Frame: 9/2011 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01151995     History of Changes
Other Study ID Numbers: 09-0735
First Submitted: June 24, 2010
First Posted: June 29, 2010
Last Update Posted: December 18, 2012
Last Verified: December 2012

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