Clinical trials are subject to US federal regulations under the Food and Drug Administration (FDA). FDA oversight regulations are designed to protect the rights and safety of trial participants, and cover how clinical trials are designed, conducted, analyzed, and reported. You can find a list of regulations at the end of the article.
In addition to meeting regulatory mandates, clinical trial project teams must protect against cybercrime. Hackers target life sciences more than any other industry. When they gain access to patient or proprietary product information, they have leverage to demand ransom to prevent release to the public or competitors.
Best Practices to Securely Manage Clinical Trial Data in a VDR
Managing clinical trial data securely protects patient privacy, maintains data integrity, and complies with regulatory requirements. Here are best practices to securely manage clinical trial documents and data:
Secure Storage:
Store clinical trial data, analytics, and project management documents in a secure and controlled environment. At one time, on-site servers met this need. In the digital age, cloud-based storage is the solution: a virtual data room (VDR). A VDR is a secure online environment for storing and sharing data files and documents, with robust, enterprise-grade security features.
The preferred VDR for clinical trials and all the life science sectors is ShareVault.
ShareVault has been serving the life science industry for more than 15 years and is the preferred Business Solutions Program provider of the Biotechnology Innovation Organization (BIO) and more than 50 other life science trade organizations.
Regulatory Compliance:
The clinical trial project must stay up to date with relevant data protection regulations and guidelines, such as the General Data Protection Regulation (GDPR) or the Health Insurance Portability and Accountability Act (HIPAA), depending on your jurisdiction. Ensure compliance with the applicable regulations throughout the entire data lifecycle.
ShareVault data rooms are 21 CFR Part 11 Compliant. When regulatory submissions are required, ShareVault’s enterprise-grade secure VDR is the preferred platform for document submissions: Electronic Trial Master Files (ETMF), Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), Drug Master Files (DMF), Biologics Master Files (BMF) Emergency Use Authorizations (EUA), and other regulatory submissions.
Data Encryption:
Utilize strong encryption techniques to protect sensitive data at rest and in transit. Encrypt databases, storage systems, and communication channels using robust encryption algorithms. With ShareVault, all files are automatically encrypted with 256-bit encryption as they are uploaded to the VDR.
Data Minimization:
Collect and store only the minimum amount of data necessary for the clinical trial. Avoid collecting unnecessary personal identifying information (PII) to minimize the risk of data breaches and enhance privacy protection.
Anonymization and Pseudonymization:
Anonymize or pseudonymize patient data whenever possible. Anonymization removes all identifiers, while pseudonymization replaces direct identifiers with artificial ones. This approach helps protect patient privacy while allowing for meaningful data analysis.
Access Control:
Implement strict access controls to ensure that only authorized individuals have access to the clinical trial data and project management documents. Use strong password protocols, multi-factor authentication, and role-based access control (RBAC) mechanisms to limit access privileges based on job roles and responsibilities.
Data Transfer Security:
When transferring data between different systems or organizations, use secure protocols such as HTTPS or SFTP to encrypt data during transit. Labs using ShareVault have built-in protections, since files in transit are via HTTPS over Secure Sockets Layer (SSL), which maintains AES-256 encryption in transit. Avoid sending sensitive data and documents via unsecured channels like email or file sharing apps with consumer-grade protections.
Third-Party Security:
The clinical trial data collection and analysis process is often a collaborative venture. Ensure that these third-party vendors have appropriate security measures in place. Conduct due diligence and vet their security practices, data handling policies, and compliance with regulatory requirements. Record their IP addresses and subject these parties to the same rigorous access control protocols that prevail for the in-house team.
Data Integrity and Audit Trails:
Implement mechanisms to ensure data integrity, such as digital signatures or checksums, to detect any unauthorized modifications to the data. Administrators of a ShareVault VDR can monitor user behavior in granular detail – what documents and data files have been accessed, at what time, with what actions. This auditing function provides user accountability and is often required by regulators for forensic purposes.
Data Backup and Disaster Recovery:
Regularly back up clinical trial data files and documents. ShareVault’s document monitoring tools allow the team to track the original user and a data file’s use over time. Have in place disaster recovery procedures to ensure data availability in the event of system failures, natural disasters, or cyberattacks.
Regular Security Assessments:
Perform regular security assessments, penetration testing, and vulnerability scans to identify and address any weaknesses in the system. Stay proactive in addressing security risks and keep abreast of emerging threats.
Training and Awareness:
Clinical trial personnel, like all life science pros, are keenly aware of security. However, with the threat of hackers, the team needs regular updates on security vulnerabilities and training and refresher courses on security best practices.
How a VDR Improves the Clinical Trial Process
A clinical trial is time- and labor-intensive. ShareVault, with its deep roots in life sciences, has developed software tools that help streamline the process, saving time and resources.
- Easy Uploads:
A clinical trial may require storage and access to hundreds of documents. ShareVault speeds the process with drag-and-drop and bulk upload features and its integration with popular file sharing apps like Box, DropBox, Google Drive, and OneDrive. - Extensive Access Controls:
Once a data file or document is uploaded to the ShareVault VDR, only authorized users have access. The team’s VDR administrator collects passwords and records IP addresses and issues usage rights specific to each user: read only, edit, copy/paste, print, download. Since a team member or third-party’s participation can change over time, the administrator can modify or deny access at any time. - Q&A:
To enhance collaboration, ShareVault’s built-in software features a Q&A module that can appear for any data file or document, and allow a user to communicate with subject matter experts. Q&A eliminates the security vulnerabilities of using email, Slack, and other less secure communication platforms. - Regulatory Access & Audits:
The clinical trial team can provide access to regulators at any time. These parties will need to adhere to the same security protocols as the in-house team and its collaborators, which telegraphs the team’s commitment to security. When an audit report is required, the team’s VDR administrator can produce a report with a single click.
Good clinical practice (GCP) regulations include:
- Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
- Protection of Human Subjects (Informed Consent) (21 CFR part 50)
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Institutional Review Boards (21 CFR Part 56)
- Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
- Investigational New Drug Application (21 CFR Part 312)
- Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
- Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
- Applications for FDA Approval of a Biologic License (21 CFR Part 601)
- Investigational Device Exemptions (21 CFR Part 812)
- Premarket Approval of Medical Devices (21 CFR Part 814)
- Financial Disclosure by a Clinical Investigator; Final Rule
- Current Good Manufacturing Practice Regulations and Investigational New Drugs
ShareVault: The Best VDR Solution for Clinical Trials
ShareVault’s virtual data room provides the patient data privacy protections required by regulators, and its built-in software streamlines the clinical trial process. Since ShareVault customizes its pricing to meet the unique needs of each clinical trial lab, it can be the most cost-effective solution, too.
To receive a customized proposal, contact ShareVault today!