What will you learn in this eBook?
Remote Source Document Verification (rSDV) is a relatively new practice. This ebook will explain its definition, present explored and piloted practices of conducting rSDV, discuss the shortcomings of traditional monitoring and 100% SDV, and showcase the cost savings that can be incurred, as well as process efficiencies compared to traditional trial monitoring when using an rSDV approach. You will learn how rSDV offers the best alternatives to ensure the quality of the trial while providing appropriate oversight to safeguard the rights and wellbeing of trial participants.
Monitoring alternatives examined in this ebook include:
- Statistical Sampling
Using mathematical sampling to determine which subjects and data should be reviewed.
- Reduced % SDV
When SDV is performed on certain data points within the CRF, as opposed to all of them, which is informed by statistical analysis or triggered by certain trial events.
- Central Monitoring - Traditional Methodology
The pros and cons of monitors faxing documents to the sponsor or CRO for review against the eCRF or CRF
- Remote Source Document Verification (rSDV)
An alternative approach utilizing technology to improve clinical trial oversight and eliminate much of the expensive onsite monitoring needed for a trial.