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NCT01151995 · ClinicalTrials.gov registry record
Effectiveness and Costs of Remote Monitoring for Clinical Trials
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 20
- Enrollment target
NCT01151995: Completed study, sponsored by University of Colorado, Denver.
NCT01151995 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151995 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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 a
Primary Outcome
Can remote source document verification replace on-site source document verification?
Interventions
- OTHER Remote source document verification
- OTHER On-site source document verification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-05 |
What the finished NCT01151995 record still lists
NCT01151995 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Remote source document verification is the first listed.
NCT01151995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01151995 about?
NCT01151995 is a clinical study titled "Effectiveness and Costs of Remote Monitoring for Clinical Trials". 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 locat...
What is the current status of trial NCT01151995?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01151995?
The interventions under investigation include: Remote source document verification (OTHER), On-site source document verification (OTHER).
Who is sponsoring clinical trial NCT01151995?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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