Clinical trials are essential for the development of new treatments. With this in mind, it becomes even more important to make sure sensitive data is protected in the process. This is especially true when these trials rely increasingly on digital file storage. Volunteers in these trials trust researchers’ ability to keep their data safe and secure, as well as protect their privacy. This can help prevent avoidable issues from occurring at any phase in the process, and reassure participants that their sensitive information is safe, secure, and confidential.
By understanding the importance of protecting sensitive data from the view of those without authorization, clinical research professionals can work toward helping trials run smoothly without noncompliance, interference from security risks, or data breaches. Read on for more information on why data privacy and security are important in clinical trials.
Data Privacy and Security in Trials: What It Means, and Why It Matters
The development of pharmaceutical products requires a lot of information to be transferred between various phases of the project. This data needs to be overseen diligently, and exchanged in ways that are as secure as possible.
Once the clinical study has been carried out, the data can be evaluated. However, those involved with the project must ensure compliance with record retention guidelines. The information must also be kept safe and secure, in order to avoid third-party interference, breach of contract, and/or the data being compromised.
Data on participants should be kept confidential to avoid third-party interference
Anyone with clinical research careers can understand why it’s important to be sure data is successfully monitored and secure, while also ensuring the processes involved prior to the clinical trial phase go ahead smoothly. Securely protecting data can also improve the sense of trust built between the participant and those administering the trials, by keeping their information strictly confidential and out of view from third parties.
Best Practices for Those With Clinical Research Careers to Follow
Anyone hoping to help conduct clinical trials after completing their clinical research training should understand how they can keep sensitive information safe and secure. One of the best courses of action here is to ensure you are using cloud-based software that you know will be safe to use, reliable, and will effectively secure any and all sensitive information from unauthorized view.
Cloud-based software can keep data secure and easy to access and distribute
This can not only allow for enhanced security of sensitive data, but also allow for greater collaboration between clinical research professionals. Successfully managing, sharing, and safeguarding the data can be achieved via a robust online infrastructure.
There are several tools clinical research professionals can use to optimize the security of sensitive data, and ones that go beyond simply creating a strong password. A best practice worth considering is to store this type of data in a virtual data room (VDR). This type of infrastructure allows for:
- Easy distribution and storage of information
- Heavy encryption of data
- Convenient usage
- Full control of information
- Access codes and verification processes to be put in place for data protection
- Reduced security risks, such as if files were transferred via email
- Remote access from anywhere in the world
- Audit logs to indicate the activity of users and their use of files
Data anonymization can prevent identifiers of a participant from being divulged
This type of system can save costs that would otherwise be necessary in a physical, non-cloud data environment. The streamlined exchange of information between users would also allow for time to be saved.
Data anonymization, which is used to encrypt or destroy information revealing a person’s identity, can also be highly effective.
Essentially, this process is used to prevent information that could possibly identify a clinical trial participant and/or their health situation. This is why one of the best practices for clinical research professionals to follow is to have a detailed process and workflow for data anonymization. By doing this, any data links compromising a participant’s identity and/or the data’s integrity can be removed or hidden.
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