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.
eSource Regulations
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.”
SMART on FHIR
In my opinion, if the requirement is to get data from an EHR system into an EDC system, the best place to start is SMART on FHIR (Fast Healthcare Interoperability Resources.) SMART stands for: Substitutable Medical Apps, Reusable Technology. “SMART Health IT is an open, standards based technology platform that enables innovators to create apps that seamlessly and securely run across the healthcare system,” according to the creators.It is a fairly new standard, but it has more momentum than any alternative. SMART on FHIR allows adding an application into the EHR system. Here’s the scenario: Imagine that the application is connecting to an EDC system, so after the data is entered into the EHR system, the SMART application is launched and selected EHR data is copied directly into the EDC system in an unaltered state.SMART EDC app Considerations
Since the EHR system will typically contain a lot more information about the patient than required for the corresponding subject in the clinical trial, the SMART application must allow the user to select the relevant data. The user would also have to select a section in which to place the data, which would typically be in a “visit,” as well as potentially add supplementary data. The EDC system would be the eSource for that additional data. Since the data later could be changed in the EHR system, a reconciliation process should be in place to capture such an occurrence.In conclusion, I am convinced that a significant reduction in a clinical trial’s SDV cost is going to come from EHR data feeds. The regulations and SMART on FHIR are supporting this option, if the right technical solution is provided.About the Author
or vice president-Product Development. Mr. Rejndrup spent nearly 20 years at Oracle Corporation, where he was a vice president of development for many clinical research applications, including systems for electronic data capture (EDC), clinical trials management, data management, medical coding and data warehousing. His experience will drive OmniComm’s products to new levels of innovation. 
