Technology

5 Ways To Keep Case Report Forms (CRF) Secure

Patients who agree to participate in clinical studies for new medications or other treatments will have to supply information to the researchers about their experiences. The best and quickest way of ensuring that the patient gives all the necessary information is by asking them to complete a CRF each day or week, depending on the specifications of the trial. 

Clinical trials rely on the accuracy of the information the researchers receive from the patients. Thus, creating convenient and accessible ways for them to provide it reassures researchers that the patient will send it in the same format each time. 

As soon as the patients send their information or CRFs back, they contain sensitive personal data of each patient that needs to remain safe from prying eyes. There are a few ways that researchers and other medical personnel can keep these secure, and below are some ideas to assist:

  1. Educate Staff And Patients About Confidentiality

Confidentiality may be something most professional medical staff don’t give too much thought to since they are used to the processes and procedures of protecting patients. Unfortunately, new staff or office admin may need to understand the importance, or some medical personnel may need a reminder. 

Cover all aspects of why confidentiality is essential in a training session like ‘CRFs explained‘ or something in the same effect for staff. In contrast, doctors can explain it to patients who agree to follow the clinical trial process when they visit their offices for the briefing.

  1. Ensure The Data Is Stored Securely

Whether the researchers prefer electronic or written CRFs, both will need secure storage on their end to prevent the leaking of confidential or private patient data. Nowadays, everything is moving towards digital solutions, including CRFs, which means that most protection options will include cyber security.  

Although some facilities have patients complete written forms, they usually convert the data digitally and store it in a platform where they can better sort everything. They also do this to easily share the info to research team members during clinical trial phases. Keeping these digital and physical forms under lock and key will be the best option for medical researchers to ensure that the paperwork doesn’t fall into the wrong hands.

  1. Don’t Allow Unauthorized Access

Researchers and their support staff will all assist in gathering personal information and CRFs from patients. Nonetheless, no one else should be privileged to see it if they have no reason to. Facilities should take great care to monitor the access to patient records and immediately follow up with any breach in patient confidentiality. 

Protecting the electronic data could be less of a hassle as passwords and access control in the system could prevent someone without the necessary clearance from viewing the information. On the other hand, physical records should have a register that all personnel sign before they may access the room. Also, someone should be in charge of monitoring all the sign-ins daily.

  1. Regularly Assess All The Risks

Criminals are almost always rather clever when devising a plan to get hold of whatever they deem valuable, like the CRFs of patients. It could mean that even when the facility considers its security adequate, there may be new loopholes that these individuals will exploit. 

For this reason, it will be wise for the research facility to assess the risks and review all the security options regularly. There may be new security products on the market that could assist with sprucing up the security measures they currently have.

  1. Use A Reputable Security Or IT Specialist To Assist

Whether a facility needs to guard physical documents or digital forms, employing the services of a reputable security firm or IT specialist can help them safeguard their patients’ information. 

Security guards could be valuable in warding off potential thieves. At the same time, cyber security measures like firewalls and advanced access control could be something that an IT specialist can set up correctly.

The Final Word

Clinical trials are necessary to explore new ways to cure or treat patients with various health problems. Unfortunately, the patients will have to supply these facilities with sensitive personal information to conduct the trial successfully. 

If a research facility doesn’t keep the patient records and CRFs safe, the information could fall into the hands. Luckily, with all the advances in security measures, researchers and patients can rest easy knowing that the data is safe. After all, research should be there to help, not harm, and managing all the risks involved with personal information will always have to remain a top priority.

Christopher Stern

Christopher Stern is a Washington-based reporter. Chris spent many years covering tech policy as a business reporter for renowned publications. He has extensive experience covering Congress, the Federal Communications Commission, and the Federal Trade Commissions. He is a graduate of Middlebury College. Email:[email protected]

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