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Step-By-Step Checklist To Guide You Through The EDC Clinical Study Build

Clinical Study Build


Clinical trials, especially those involving the testing of medical devices, might greatly benefit from the use of an Electronic Data Capture (EDC) system. Using an EDC system simplifies data gathering, thus boosting the study’s effectiveness as a whole.  To keep your study going smoothly, it’s crucial that the streams of data be available and usable in real time. The validity of the trial’s findings depends on careful data management to guarantee the safety and effectiveness of the investigated intervention. For a clinical trial, developing an EDC system entails many processes that must be meticulously planned during clinical trial consulting and carried out to guarantee data accuracy, completeness, and security. The following set of steps will help you complete the EDC clinical trial build process:

Map out your needs

There’s a lot to sift through, and the fact that there are so many systems doesn’t make it any easier to sort through them, especially since each one has its own shiny yet vague marketing shell. Therefore, you should first establish the parameters of your current clinical study and identify themes that will be present in subsequent trials. Make sure this core system has the features you need to meet requirements at each stage of your hybrid or virtual clinical trials.

Identify complementary data collection methods

What kinds of additional data collection methods and completely integrated interfaces would you need to provide a full-fledged EDC solution? Possible approaches include ePROs (electronic patient-reported outcomes), eConsent, survey dissemination, offline data collection, and external data import. Which aspects of trial management, such as site payments, randomization, event adjudication, IP inventory tracking, medical coding, document uploads, redaction, etc., must be built into the system from the get-go? Some of these EDC elements may open up fresh avenues for you to explore in terms of designing and carrying out your research. To help you make a well-informed software choice, it is helpful to establish these fundamental criteria first.

Ensure system efficiency

It takes numerous moving pieces, including user experience, data processing workflows, training, data reporting, and data downloads, for a CRO or sponsor to perform an efficient study that delivers high-quality data and solid risk management. Fortunately, these may be assessed by requesting a demonstration of the technology or gathered from prior experience. However, without an in-depth knowledge of data management, it is easy to miss any system faults throughout these examinations. Given the central role played by these features in the collection and processing of data, subpar performance can have serious consequences for the success of a study, including patient and staff dissatisfaction, inefficient workflows, extra expenses, and poor results.

Ensure its compliant and secure solution

Each EDC solution must be secure and compliant with all applicable regulations. It is possible to request certifications and other proof of compliance from vendors. The quality of the hosting service, technical assistance, backups, and recovery methods should all meet your requirements. As an additional point, the cost is often a big consideration for sponsors. Sponsors have to figure out license prices and build timeframes, and the expenses that come with each extension or recalculation. Having a clear idea of your needs vs. your wants and a thorough understanding of how each choice compares to the competition will help you determine if the total expenditures will be worth the value the EDC adds to your research.

By going through this step-by-step list, you can build an EDC system for your clinical study that works well and meets the study plan requirements and regulatory standards.

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