Technology has transformed the way we do clinical research and trials. The introduction of electronic data capture systems (EDC) has made the process a lot easier. It is important to consider data Security and EDC when evaluating an electronic data collection system. However, the introduction of technology brings its headaches as regulatory bodies try to create ethical standards to keep everything in check.
Cyberattacks have become more common as clinical trials have adopted the technology. Confidential documents relating to COVID-19 studies have been leaked in the past. In saying that, the use of technology shouldn’t be discouraged. Here are some guidelines to follow when choosing a secure EDC.
Secure Infrastructure Design
You need to ensure that the EDC you choose has a secure infrastructure design. No data should leave the system before being encrypted via SSL and RSA keys. The clinical trial setting should be closely observed by relevant authorities, and only relevant personal should have access. There should be adequate backups of data, ideally in another location. You need a multi-layered security approach to secure your EDC system and protect your physical and digital assets.
Data Security and EDC – Transfers Should Be Secure
As mentioned, restricted access is key to maintaining a secure EDC system. Ensure that you have a multi-layered security system in place. You should only allow access to employees in a limited capacity. They should only have access to systems and configurations relevant to their job functions. To avoid theft or leaks, any data transfers should be logged and carried out by authorized personnel.
Monitoring and Vigilance
Data integrity is crucial in a clinical setting, and you need to ensure that any access, changes, or transfers to your data are logged, monitored, and have a proper audit trail. Adequate backups should always be maintained, and data should be backed up automatically and frequently. There should be a 24/7 monitoring system to ensure your crucial data’s safety.
Incorporating security mechanisms in your EDC can be difficult. Therefore, you need a trusted supplier of clinical data EDC systems that are robust and secure. If you’re on the lookout for one, check out the products provided by ClinicalPURSUIT.
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