9 February, 2021, by ClinCaptureUser
As the number of remote and decentralized trials increased due to the COVID-19 pandemic, the need for technology and questions about what is needed to run these trials efficiently also rose. We will break down what electronic Source (eSource) is and why you should consider it for your clinical trial.
What is eSource?
eSource data is data initially recorded in electronic format, according to guidance from the Food and Drug Administration. It “can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.”
What are the benefits?
Capturing source data electronically will yield the following benefits:
- Eliminates duplicate information
- Reduces transcription errors
- Facilitates real-time and remote monitoring of data
- Saves time
Additionally, Virtual Data Capture® (VDC®) eSource maintains a full audit log for all data entered into the system and all site users have a unique login credential. So, each data point that is entered is recorded with time, date, and data originator on the log.
Is it compliant?
ClinCapture ’s software allows its users to remain HIPAA and GDPR compliant.
How can I get eSource?
ClinCapture’s Captivate® is optimized for VDC® eSource. Users will receive VDC® eSource without needing additional software. To learn more about VDC® eSource, schedule a demo here.