Information Security Concerns in Clinical Trials

clinical trialsClinical trial studies are the heart of advancing medical science. The goal of any trial is to collect data that may lead to more effective drug therapies, diagnostics, treatment protocols and devices. In today’s techno-centric world, security is always going to be an valid concern. Responsibility for the safety of clinical trials falls on the sponsors and investigating group. Proper clinical trial management is the key to securing data for anyone taking part in a study. Following is a discussion of three ways leading medical research organizations are helping to ensure the security of all parties involved in their clinical trials through the use of sophisticated software.

Clinical Trial Management Systems

The proliferation of information technology systems has introduced more computer software environments to clinical studies. One approach often seen to enhance trial security is the use of a clinical trial management system – independent software able to assimilate large qualities of data. The clinical trial management system is a comprehensive tool that controls all aspects of the trial including:

      • Planning
      • Budgeting
      • Patient management
      • Government compliance

Each separate program offers different features. This is one way that researchers can ensure security for both their patients and data. The programs offer a desktop dashboard that works as a standalone interface to control the software.

Clinical Trial Portal

A clinical trial portal is a web-based system that is study specific. This platform gives sponsors and investigators an online, centralized remote access point to input data, review information and create applications for trial participation. It will monitor all access to help prevent intruders and regulate conduct.

Clinical trial portals come in different formats. The clinical trial investigator portal provides secure information to train investigators for the study. This alleviates the need to send data via email or another unsecure process. The portal hosts confidential documents, study protocol and brochures. It also serves as a central location when recruiting sponsors. With a proper logon, potential sponsors can access the system securely and find out more about the study. Through the portal, sponsors can review the database of investigators, analyze their qualifications, and read study related documents.

The ability to sign documents electronically is a security benefit of a clinical trial portal. Digital signatures save time and money, as well as cut back on hardcopy storage needs. Through electronic signatures, sponsors and investigators can sign off on protocols, training material and other documents without waiting for messenger deliveries or unsecure emails.

Interactive Voice Response Systems

These programs are an effective way to manage a clinical study that uses phone registration. The program relies on a voice recognition platform to conduct the study remotely. Patients can access the surveys or information reporting system via their personal phones. Without the proper security, phone systems are vulnerable to hacking or misuse. The voice recognition program helps to limit access to the various areas of the study. When a patient calls in, the system does a voice analysis to verify the identity of the caller and routes them to the proper arm of the study automatically.

Security is a concern with clinical trials, especially in the world of electronic record keeping. Researchers can work with specialized software programs to cut back on the risk of patient information and study data leakage.

About the Guest Author

Don Wise is a medical blogger with specific interest in how technology is transforming the healthcare industry.  More of his technology/healthcare findings can be found at Nursing Informatics Program Rankings.

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