9 February, 2021, by Clincapture User
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?
17 March, 2021
What is eConsent and what are the benefits?What is eConsent? The Food and Drug Administration has defined electronic informed consent (eConsent) as “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study to obta
25 January, 2021
Meet the Team: Samantha PurdieSettled in her home in Tennessee, Samantha Purdie is busy building studies in ClinCapture’s Captivate™. Shortly after joining ClinCapture in the summer of 2020, she adapted quickly and jumped right in. One day, on a weekly conference call with the team Purdie was asked how her workload is and if she can handle the additional studies. Her response? “Bring it on.” A response that