12 March, 2019, by clincapture-client
In recent years, you have probably heard the word “eSource” thrown around as it pertains to Clinical Data Management. Questions have arisen like: What is eSource exactly? Do you buy eSource from a vendor? How does it compare to EDC systems? Is it compliant? This blog post will outline the definitions and misconceptions around eSource that every sponsor and CRO should be aware of.
FDA’s Guidance for Industry: Electronic Source Data in Clinical Investigations, says, in part:
“Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. This direct entry of data can eliminate errors by not using a paper transcription step before entry into the eCRF. For these data elements, the eCRF is the source. If a paper transcription step is used, then the paper documentation should be retained and made available for FDA inspection.”
So then, eSource simply means the electronic data is the source data. In other words, eSource is not a mobile app or fancy new feature, but it is the way of collecting data in which the data is entered directly into the electronic record. Therefore, those who are interested in eSource may wish to choose an Electronic Data Capture (EDC) system which is optimized for this method.
Finding a system that works for your study
When choosing an EDC provider, remember to ask if their application is optimized for eSource. You may wish to avoid systems that require tedious steps for your sites to capture and send information to an EDC system. And remember, eSource is not as simple as using a mobile device; it’s how you collect the data that matters.
Do you have any questions about this article? Contact email@example.com
About the author
ClinCapture provides a powerful eClinical platform that enables sponsors and CROs to rapidly build and deploy studies, lower clinical trials costs, and streamline data capture processes. Offering a host of private cloud solutions, ClinCapture’s technologies help advance the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions. For more information, please visit clincapture.com or follow us at @ClinCapture.
7 October, 2019
What’s Private Cloud Infrastructure (& Why Every EDC Provider Should Offer It)Sponsors and CROs - Do you know where your clinical trial database resides? Unless you have on-premises servers, your clinical trial database most likely resides on the cloud. The cloud is not a one-size-fits-all solution and can greatly affect various software aspects, such as software speed and performance. When choosing a
4 October, 2019
Have a restricted timeline for your study? Questions to ask your EDC provider.As a research organization, you are probably familiar with the strict guidelines to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and other review processes. Since research companies are usually on a tight schedule for their products to reach the market before competitors, filing early is critical. This is most important if you a
17 September, 2019
Can your Electronic Data Capture system handle a large amount of data?If you have ever ran a data-heavy study, especially a Late Phase study that relies greatly on capturing a high volume of subject data usually spread throughout a long period of time and large geographical area, you know that having the right Electronic Data Capture system is vital. As an industry professional, you may be aware of the negative effects that can result from picking an unreliable syst