Effectiveness and Costs of Remote Monitoring for Clinical Trials

NCT01151995 | Completed

• 1 other identifier: 09-0735
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Remote Monitoring

Keywords

Clinical Trial Monitoring; Effectiveness of remote monitoring; Efficiency of remote monitoring; Costs of remote monitoring

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  Can remote source document verification replace on-site source document verification?

  9/2011

• Efficiency and Cost

  Differences in time and costs

  9/2011

Study Arms (2)

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

On-site monitoring

Traditional source document verification will be performed when study monitor is on site

Other: On-site source document verification

Interventions

Remote source document verification OTHER

Remote access to electronic medical records of the 5 participating sites

Remote plus on-site

On-site source document verification OTHER

Study monitor will perform on-site source document verification during routine visit to the five participating sites

On-site monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not enrolled in the NIH-sponsored ARDS and BARC/CLiC clinical trials

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Massachusetts General Hospital: collaborator
• University of Michigan: collaborator

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Biospecimen

No biospecimens collected for this protocol

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 29, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

US (1)