Not long ago, clinical trials involved 100% onsite monitoring in an effort to ensure high data quality. But how effective and efficient was that process? Several analyses have shown that only 1-2% of data is corrected as a result of source data verification (SDV). Therefore, the concept of risk-based monitoring (RBM) was born. The goal was to complete a more targeted monitoring (<100% SDV) without compromising patient safety or data quality.
However, even though RBM can dramatically reduce the level of SDV, it would be beneficial to explore other ways to reduce costs. By examining why SDV has to be done in the first place, the answer is quite simple: SDV has to be done because electronic data capture (EDC) systems are usually not the source system for the data. In reality, the majority of data is collected in other systems and re-typed into an EDC system.
This reality yields other pertinent questions: Can the EDC system be the source system, or can the EDC system receive direct data feeds from the source system? To answer those questions, eSource regulations provide a good starting point.
The eSource regulations state:“Capturing source data electronically and transmitting it to the eCRF should:
- Eliminate unnecessary duplication of data.
- Reduce the possibility for transcription errors.
- Encourage entering source data during a subject’s visit, where appropriate.
- Eliminate transcription of source data prior to entry into an eCRF.
- Facilitate remote monitoring of data.
- Promote real-time access for data review.
- Facilitate the collection of accurate and complete data.”