What is EDC?
Electronic Data Capture (EDC) is a software product that is utilized by Life Sciences Organizations who perform research studies in a regulated environment. There are many EDC products available - each product is used to record and manage the research data that is generated for the purposes of a clinical research study. Typical EDC products have standard data forms that can be used for any study, workflow rules to help with data entry, logic checks to verify the quality of the data and reporting metrics for progress.
Minimizing the inefficiencies of paper-based studies is one of many EDC benefits.
In general, EDC products are used to record specific data about individual subjects (e.g. patients) that participate in research studies. For example, if a biopharmaceutical organization is testing their new diabetes drug in 200 subjects at 10 medical centers, each medical center will use the EDC to enter the research data about their participating study subjects.
Before the medical centers are able to record the research data in the EDC, the data forms have to be designed with the appropriate pages and fields that relate to the diabetes research study. Typically the sponsor organization will work with the EDC vendor or provider to design the pages and fields needed for their research study. Once the EDC is ready to use, the sponsor organization or their representatives will train the research site users how to use the EDC for the specific study. Because each EDC system is unique and each research study is unique, knowing how to navigate through the systems is critical for quality research data.
SimpleTrials CTMS does not include EDC functionality, however, we do integrate with many currently available EDC systems. More information is provided below.
What data typically goes into an EDC?
In general, data that is entered into an EDC includes a combination of personal health information (PHI) as well as general information about each study participating in the research study. When a subject signs informed consent to participate in a study, the details of the study are provided.
Most studies will collect some background information about each participant. For example, the person’s age, recent bloodwork, whether they have any ongoing medical conditions and details about the research study disease (e.g. severity of their diabetes condition, what medications they are taking, etc).
Study-specific information, also known as “research data”, will also be collected and recorded during the study. For example, each time the subject comes to the clinic for a site visit, they may be asked to complete a survey about how they are feeling, provide details about the time they take their medication each day and have a brief physical exam. These items are “research data” because the patient would not normally be reporting this detail to their doctor for routine diabetes care.
Additional information may be collected in other systems such as laboratories and imaging facilities. For example, cancer studies may require repeat CT scans and bloodwork. Some EDC systems can “connect” with these additional systems.
In general, subject data entered into an EDC system does not contain information to identify subjects. For example, the person’s full name, address, contact details.
What EDC data is used in a CTMS product like SimpleTrials?
SimpleTrials CTMS is a study management tool that is utilized by life sciences organizations to manage multiple research studies. The SimpleTrials CTMS is used to manage much more than just subject records within individual research studies. Subject tracking details within SimpleTrials include:
subject status on the study (e.g. individuals in screening, currently participating or completed with the study),
the dates of subject clinic visits or phone calls, and
general details about the visits. For example, whether the visit was fully completed per the research study needs and whether the research data has been entered into the EDC.
If SimpleTrials clients are managing investigator site payments, details about subject visits are used to generate payments and keep track of study budgets. Subject data in SimpleTrials is also used to provide metrics and reports for sponsor organizations to see how study milestones are being met, trend protocol deviations, and write reports about site monitoring visits.
In order to manage the above subject aspects in SimpleTrials CTMS, the EDC data that is integrated (e.g. ‘shared’) may include:
the subject number (anonymized)
visit or phone call dates
visit status
study status and subject status
protocol deviations
When SimpleTrials is integrated with EDC systems, information gathered does not include detailed information about a subject such as personal health information or the study outcome (e.g. whether the research “helped” the subject) -- these items would be maintained in the EDC.
What are the benefits of integrating EDC with CTMS?
Improved oversight of screening, enrollment and subject visit progress.
Automated daily updates, from EDC to CTMS, minimize manual data entry.
Having complete, accurate, and near-real-time subject data in the CTMS allows these features to be utilized:
Dashboards and analytics
Subject Payments
Protocol Deviations
Electronic Visit Reports (for consistency with monitoring subject data)
Which EDC systems does SimpleTrials CTMS integrate with?
As a best-in-class CTMS, seamless integration with EDC systems is a priority for SimpleTrials. When integrated, SimpleTrials compliments your EDC system (SimpleTrials does not attempt to duplicate the functions or full data set available in EDC). The following EDC systems are available for integration with SimpleTrials. Additional systems are being added all the time so please check with us if the system you are considering is not on the list!
Castor EDC
ClinCapture
ClinInfo eCRF
Datatrak
DSG eCaseLink
Ennov EDC
IBM/Merative CD
iMedNet
Medrio
Medidata RAVE
REDCap Cloud
TrialKit
Veeva CDMS
Learn More
Would you like to learn more about the benefits of an integrated EDC to the SimpleTrials CTMS? Please contact us and we will get in touch.