An Ultimate Guide to Electronic Data Capture System in Clinical Trials

March 01, 2022
An Ultimate Guide to Electronic Data Capture System in Clinical Trials

An electronic data capture system is an essential software tool in clinical trial research management as all clinical researches rely on how accurate the data is. The EDC software makes it quite easier to collect, clean, and analyze the data generated from clinical trials.
Here in this article, we have shared a detailed study on technical and practical aspects related to electronic data management systems including their acquisition costs and uses.

Electronic Data Capture for Clinical Trials – Everything You Must Know!

As mentioned above, an electronic data capture clinical trials system can generate a case report by utilizing the data fetched from clinical studies to collect, clean, transfer, and process it.

However, the healthcare institutes are not legally obliged yet to use EDC systems in their clinical trials or research but electronic data management systems are greatly helpful to streamline the entire process while saving a lot of time and cost.

If in any case, clinical data has to be collected by some means, Electronic Data Capture (EDC) solutions are undoubtedly the best options. 

The Benefits of Using Electronic Data Capture Systems in Clinical Trials

Using an EDC system certainly offers a lot of advantages when conducting a clinical trial. Let’s read the prime most benefits here!

  • Using an electronic data capture clinical trials solution streamlines the entire process of data collection when compared to paper-based data collection. 
  • Clinical sites can access the EDC system from any device and enter data as quickly and easily as possible. 
  • The data can be easily accessible to data reviewers and managers that make it hassle-free to write or ship paper forms. And also to issue queries to sites to solve discrepancies.
  • Electronic data management systems accelerate the data cleaning process. 
  • An EDC platform also guarantees the authenticity, integrity, and security of solid data by enabling advanced mechanisms to manage access controls and data traceability.

How Data is Captured in Clinical Trial Management Systems?

Clinical trial research management systems collect different types of data depending on the therapeutic area of the clinical trials.

For instance, in oncology studies, the following data is used – 

  • Demographics
  • Medical History
  • Vital Signs
  • ECOG Performance Status
  • Electrocardiogram Data
  • Biochemistry
  • Hematology
  • Coagulation Tests
  • Urinalysis
  • Pregnancy Tests
  • Adverse Events
  • Concomitant Medications
  • Tumour Assessments
  • Treatment Data
  • Survival Follow-Up And
  • Death Information.

By putting EDC software in place, the users will be able to easily access the data by typing the clinical data in the fields contained in the various data forms in the software. Hence, the local site users can perform data entry in any electronic data capture system remotely.

Once the data has been entered into the software, it’s time to refine the information by detecting and solving discrepancies for which the identification and correction process is performed which is also called ‘Data Cleaning’. The process is typically performed by the data managers who will periodically review the Electronic Data Capture information and issue queries to sites asking them to clarify the data discrepancies. 

This process is repeated until all the data is cleaned completely. Then, it can be exported and analyzed again.

So, this is how EDC is used in Clinical Trials. If you’d like to learn more about the key features and functionalities of an Electronic Data Capture for clinical trials, connect with our team of experts. We will guide you to use EDC the right way to streamline your clinical trials and drive more effective results out of them. 

If you are looking for developing a healthcare software similar to eCTMS then contact us at .