Data collection for your clinical trial doesn’t have to be an inefficient process. If you’re planning to complete an FDA submission and/or are frustrated with your current method, it may be time to consider an electronic data capture (EDC) system. However, one obstacle you may experience is convincing the decision-maker(s) to make this move.
EDC systems not only increase time efficiencies and cost savings for clinical trials but they also promote data integrity. Here, we look at five arguments you can use to convince any skeptic about the value of EDC.
1. Explain the importance of regulatory compliance
Making sure your data submissions comply with FDA regulations is key to getting your device or drug approved. Using other methods, such as Excel documents, can result in non-compliance because it is easy to manipulate or alter data in a manner that’s nearly impossible to detect. An EDC system should have audit trail functionality that tracks all changes made to data. It should also have technical controls in place for electronic signatures that require a unique username and password. Make sure your chosen EDC system is compliant with 21 CFR Part 11 if you plan to submit your data to the FDA.
2. Describe how it prevents unauthorized access to data
Most EDC systems have measures in place to prevent unauthorized personnel from accessing restricted study data. This ensures the integrity of the data collected is not compromised. EDC systems allow you to designate different access levels based on each staff member’s role in the protocol. Using their own unique username and password to log in, each user is only able to perform certain actions associated with the role they are given.
3. Demonstrate the cost-savings
The phrase ‘do more with fewer resources’ is one almost everyone involved in clinical research understands. The right EDC system can save clinical research staff time by reducing inefficiencies and opening dialog between sites and sponsors. An EDC system allows you to build electronic case report forms (eCRFs), enter study data, resolve queries and lock data all in one system. Data reviews are performed in real-time, soon after the data is entered. No more waiting for the mail to arrive. Using an EDC could actually reduce your time to market.
4. Talk about the importance of data integrity
Nothing is more frustrating than sifting through inaccurate and inconsistent data for a protocol. Using an EDC system gives you the ability to control and create standardized eCRFs to collect the data you need for your study eliminating inconsistencies. An EDC system should offer the option to create edit checks that help prevent invalid data from being entered into eCRFs. This ultimately results in fewer errors, increased data quality and completeness and better metrics reporting.
5. Reveal the benefits of eCRFs
EDC systems should allow you to create and store eCRFs within the application. If using a cloud-hosted system, authorized users are able to remotely access this library of forms from anywhere. No more guessing if the form you are using is the most recent version. It’s also easy to identify the version of the form should you have a need to use different versions for participants in the same protocol. Having a standard library allows you to reuse eCRFs across multiple protocols so you’re not starting from scratch.
Creating efficiencies in the clinical research industry continues to be a focus for many organizations. Implementing an EDC system is a great way to increase productivity, provide cost savings and deliver improved data integrity for your protocols. Now that you understand the value of an EDC system, you’re well equipped to make the case for a system at your organization.
To learn more about EDC software and the basics for finding the right system, download our free eBook, “An Introduction to Electronic Data Capture.”
This article was originally published on May 31, 2016.