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Confidentiality and Security in Clinical Trials


As more clinical trials move online, confidentiality and security are of more importance than ever. Today we’ll cover some basic considerations for maintaining security in virtual clinical trials.


Regulations for Clinical Trials

Some key legislation exists to protect the privacy of patients involved in clinical trials. One key example of this is HIPAA, the Health Insurance Portability and Accountability Act with came into place in the late nineties. This act protects the confidentiality of medical procedures, including clinical research, by enforcing the following regulations:


Pre-Authorization and Continued Consent

A participant must grant written consent before an organization can legally collect any protected health information. In clinical trials, this demands the signing of an informed consent document which states that the participant has read and understood the contents of the research protocol. Protected health information does not include basic demographics, but does include things like health history and test results.

A participant is also allowed to revoke consent at any time, though any data collected up to that point is not required to be deleted (but it can no longer be shared or incorporated into publication.)


“Need to Know” Clauses

Researchers should only collect data essential to the trial at hand, and should not share medical data with other members of the research team or professionals outside of it that is not strictly “need to know.” Only the necessary PHI can be shared when it is required for the research.


Other Responsibilities

It is also crucial for the research team of a virtual clinical trial to store and transfer participant data in a secure manner. The health data should be collected in a manner that is digitally impervious to hacking or other methods of information leaking. Additionally, privacy should be a priority in clinical trials, even among the members of a research team. It is generally advised that only a few designated researchers have access to the collection of participants’ data, in order to bolster confidentiality efforts.


Security in Clinical Trials FAQ:

Does HIPPA Apply to clinical trials?

HIPPA requirements do apply to clinical research, and the privacy of participant data must be protected.

Are Online clinical trials secure?

Digital clinical trials are just as secure as centralized trials when taken on by responsible digital CROs who prioritize confidentiality and security.


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