Remote Monitoring Clinical Trial
Official title:
Effectiveness and Costs of Remote Monitoring for Clinical Trials
Verified date | December 2012 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado at Denver and Health Sciences Center | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Massachusetts General Hospital, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness | Can remote source document verification replace on-site source document verification? | 9/2011 | No |
Primary | Efficiency and Cost | Differences in time and costs | 9/2011 | No |
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