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Remote source document verification in two national clinical trials networks: a pilot study.
Meredith Mealer1, John Kittelson2, B Taylor Thompson3
1Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
Plos One
|December 19, 2013
Summary
Remote electronic monitoring for source document verification (SDV) is feasible for large clinical trials, despite varying site technologies and policies. This method successfully monitored over 99% of data values, showing promise for efficient trial oversight.
Area of Science:
- Clinical Trials
- Health Informatics
- Regulatory Science
Background:
- Large-scale randomized controlled trials (RCTs) face significant barriers including high costs, operational complexity, and stringent regulatory requirements.
- Traditional on-site source document verification (SDV) is a critical but resource-intensive component of ensuring data integrity in clinical research.
Purpose of the Study:
- To evaluate the feasibility and efficiency of remote electronic monitoring for SDV as an alternative to traditional on-site monitoring.
- To assess the success rate of remote SDV in locating data values and compare the time required for remote versus on-site verification.
Main Methods:
- A randomized convenience sample of study subjects from five hospitals across two NIH-sponsored networks were assigned to either remote SDV or traditional on-site SDV.
- Monitors were granted remote electronic access to study data, and the number of verified data values and time taken for both methods were recorded.
- Data were collected and analyzed comparing remote and on-site SDV in both adult and pediatric networks.
Main Results:
- Over 99% of data values were successfully monitored remotely across both adult and pediatric networks, with minimal data unavailability (0.47% in adult network).
- While not statistically significant, remote SDV showed a trend towards consuming more time per data value and per case report form compared to on-site SDV.
- Significant variations in technical capabilities, remote access policies, and regulatory requirements were observed across participating sites.
Conclusions:
- Remote electronic monitoring for SDV is a feasible approach for large-scale clinical trials, demonstrating high success rates in data verification.
- The study highlights the need for developing consistent access policies and standardized procedures to facilitate the integration of remote monitors into site systems.
- Addressing site-specific technological and policy variations is crucial for the widespread adoption of remote monitoring in clinical research.
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