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How Electronic Data Capture Improves Data Quality In Clinical Research Studies

Electronic data capture systems are used nowadays by life science and other allied medical companies. EDC systems are also used as a vital technology for conducting clinical research trials, particularly for large multi-site clinical trials. Check out the video to learn more :

EDC can reduce data errors from an investigative site to a biopharmaceutical firm by 70-80%. EDC technology can also slash database lock time to merely hours. Thus, you can expect results at the processs earliest possible point instead of the typical 4 to 8 weeks.

Shortening timelines and improving quality are at the forefront of clinical trials and drug development programs.

What Comprises a Clinical Data Management System?

Not all clinical data management solutions are the same. While EDC systems vary, they are generally designed to streamline data review and collection.

Some of an EDC systems common features are:

- Role-based User Permissions. With the EDC system, every user account has a unique password, designated permissions, and username. Such feature limits what a particular person can view and define the actions that can be done within the system.

- Hosted Solution. Many eClinical solutions are cloud-based and the data entry is done on an interface that is web-based. Software vendors must ensure the data is stored safely, backed up, and protected.

- Data Entry. After a protocol is established, data is entered into the right eCRF (case report form). Real-time data checks are done as they are typed into the system.

- eCRF Designer. When you create eCRFs, you have design options that allow you to optimize data entry forms and export. Saving eCRFs in a common library allows for eCRF reuse. When you create eCRFs, you can program edit checks to help you avoid errors in data entry.

- Audit Trail. A clinical trial management system that fully supports compliance and validation should have established the right technical controls. Such requirements include an audit trail that tracks an eCRFs history.

This includes who altered the eCRF, when the change was made, the new and old values entered, and the reason for the change.

- Query Management. An EDC system gives streamlined communication between coordinators, data managers, and monitors. Majority of the systems have queries that are auto-generated and the capability to add queries manually.

The queries should have a response and must be answered before the data may be locked.

- Data Export. Once the data can be retrieved, there are exports that can be easily accessed. Some EDC systems also have built-in metrics reporting that allow you to look into a studys progress.

Who Uses EDC?

The three main electronic data capture software users include the:

- Site. A site is usually a clinic or hospital and is the entity that coordinates and gathers data from clinical trial subjects or patients. The site employs study coordinators who are tasked to input data into the EDC system. The investigator (or the physician-in-charge) of the site reviews and signs the data.

- Sponsor. A clinical trials sponsor is the company that owns the trial. These sponsors can include life sciences, device, and biopharma companies. Sponsors can assign monitors to visit the sites to check data source documents.

- CRO. A CRO (contract research organization) works with the sponsor to plan and conduct the trial. There are certain trials wherein the CRO runs the trial for the sponsor. There are also other trials wherein the CRO only assumes key roles like analysis, monitoring, and data management.

Why Use Clinical Data Solutions for Trials?

Most of the new clinical trials nowadays utilize EDC. Moreover, the use of the EDC takes care of productivity and efficiency issues and can also reduce clinical trials cost. Some of the advantages of using EDC include:

- Faster Data Access. Web-based clinical trial management software can offer you nearly real-time data access in a clinical trial. This allows you quicker decision making, and such system can support trial designs that are adaptive.

- More Efficient Processes. The site can be guided by the EDC via a series of study events. You can request only the pertinent data for a certain patients condition at a specific time.

- EDC facilitates the procedure of clearing up data discrepancies with tools for resolving and identifying site data issues. The system can also lessen the number of personal site visits needed during a clinical trial.

- Cleaner Data. The clinical trial software is good at enforcing particular aspects of the datas quality. Programmed edit checks can ensure the data meets required ranges and formats before the trial base accepts the data.

Conclusion

EDC continues to grow and evolve. As EDC is the eClinical industry's cornerstone, more software solutions have been developed to complement it. Other software is developed for Imaging, PRO (patient-reported outcome), CTMS, and more.

Introduced through EDC, technology has led to more opportunities and it will need more standards to attain the full efficiency potential made possible by technologys evolution. The electronic data capture industry will still evolve; leveraging technologys expanding power to manage clinical trials and the related data in order to bring relevant treatment to people who need it.

References

Forte Research Systems. (n.d.). An Introduction to Electronic Data Capture. Retrieved from http://cdn2.hubspot.net/hub/216272/file-635318734-pdf/EDC_eBook.pdf?t=1399654204335

Gluck, B. (n.d.). A Brief History and Look at the Future of Electronic Data Capture. Retrieved from file:///C:/Users/Cate/Downloads/Brief-History-and-Future-Look-of-EDC.pdf

Kush, R. (2006, June). Electronic Data Capture Pros and Cons. Retrieved from https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf

Medidata Clinical Cloud. (2015, June). How Your Electronic Data Capture (EDC) System Can Streamline Clinical Site Payments. Retrieved from https://www.mdsol.com/sites/default/files/How%20Your%20Electronic%20Data%20Capture(EDC)%20System%20Can%20Streamline%20Clinical%20Site%20Payments.pdf

OpenClinica. (2016). Fundamental Aspects of Electronic Data Capture. Retrieved from https://www.openclinica.com/electronic_data_capture/

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