ISO/IEC 27001:2022 in Clinical Trials: Turning Data Security into a Quality Standard

Table of Contents

Data security in clinical trials is not merely a technical matter. It is an area that directly affects the protection of patients’ rights and privacy, the credibility of study results, and the regulatory responsibility of sponsors and investigators. In the era of widespread use of computerized systems, cloud-based solutions, and global data processing, data security must be managed in a systemic manner, well-documented and compliant with both industry-specific regulations and internationally recognized standards.

The ISO/IEC 27001:2022 standard provides such a unifying framework for information security management, which defines requirements for an Information Security Management System (ISMS). Although this is a general-purpose standard and not dedicated exclusively to clinical trials, its structure – in particular Annex A – provides a tool for a practical implementation requirements arising from GCP, ICH E6 (R3), Annex 11, 21 CFR Part 11, and guidelines on computerized systems used in clinical trials.

ISO/IEC 27001:2022 as the Foundation, GCP Guidelines as the Industry Context

Clinical trial regulations primarily focus on data integrity, traceability, auditability, and patient protection, while ISO/IEC 27001:2022 provides proven governance and control mechanisms that enable these requirements to be met in practice. In this sense, the standards and guidelines do not compete with one another; rather, they are complementary.

Annex A of ISO/IEC 27001:2022 contains a list of 93 security controls. Their detailed description and division into four main areas – organizational, people-related (human resources), physical, and technological – are defined in in the complementary standard ISO/IEC 27002:2022. These controls have a direct impact on the requirements on systems and processes, including those used in clinical trials.

Organizational Controls – Responsibility Structure and Oversight

Organizational controls form the foundation of the entire information security framework. They include information security policies, clearly defined roles and responsibilities, risk management, vendors oversight, and incident response.

In the context of clinical trials, this area closely aligns with ICH E6 (R3) GCP requirements regarding clearly defined responsibilities of the sponsor, investigator, and IT system providers. ISO/IEC 27001:2022 strengthens these expectations by requiring formal risk management, documented decision-making, and the implementation of procedures (SOPs) that regulate, among others:

• access to clinical data,
• change management in computerized systems,
• handling of data security breaches,
• oversight of service providers and subcontractors.

In practice, this means that vendors qualification and audits, data processing agreements, and service level agreements (SLAs) are not merely “good practice,” but integral components of a coherent security framework required by both GCP and ISO/IEC 27001:2022.

People Controls – the Human Factor under Control

The human factor remains one of the most significant sources of information security risk. ISO/IEC 27001:2022 requires organizations to manage information security throughout the entire lifecycle of employees and collaborators – from recruitment, through employment, to termination of cooperation.

In clinical trials, this is particularly important because access to systems (EDC, ePRO, eTMF, and, where applicable, AI-based platforms) is provided by various roles: investigators, study coordinators, monitors, statisticians, IT administrators, and external provider. GCP and Annex 11 guidelines clearly indicate the necessity of:

• appropriate training of system users,
• granting access in accordance with the principle of minimum privileges,
• unambiguous user identification,
• immediate revocation of access following role changes or termination of collaboration.

ISO/IEC 27001:2022 systematizes these requirements imposing an obligation of formal procedures, authorization records, and periodic access reviews.

Physical Controls – An Often-Underestimated Element of Data Integrity

Although clinical data are mostly electronic today, their security still depends on physical safeguards – both at investigational sites and within data centers facilities.

ISO/IEC 27001:2022 requires physical protection of IT infrastructure, server rooms, workstations, and data storage media. In clinical trials, these controls support compliance with Annex 11 and 21 CFR Part 11 expectations for safeguarding systems and data against unauthorized access, data loss, or destruction.

This includes, among others:

• access control to areas where clinical data are processed,
• protection of endpoint devices (laptops, tablets, mobile devices),
• safeguarding source documentation and archival media,
• security of infrastructure used by cloud service providers.

Technological Controls – Technology in the Service of Data Integrity

Technical controls are the most visible aspect of information security, however, they cannot operate in isolation from people and processes. ISO/IEC 27001:2022 and industry guidelines unanimously emphasize the need for mechanisms such as:

• strong user authentication,
• role-based access control,
• encryption of data at rest and in transmission,
• full audit trails,
• backup, archiving, and data recovery mechanisms,
• protection against cyber threats.

All of these elements are simultaneously crucial to meeting ALCOA++ principles, particularly with respect to data availability, integrity, and traceability (see also ALCOA++ in Practice - A New Dimension of Data Quality ).

Cloud Services and Data Location – Global Trials, Local Regulations

An increasing number of systems used in clinical trials operate in cloud-based model. While cloud solutions offer scalability and availability, they also raise questions regarding data location, jurisdiction, and data transfers outside the EU.

ISO/IEC 27001:2022 requires a risk-based approach and effective supplier management to establish and maintain appropriate controls over where and how data are processed and stored. GCP, GDPR, and national regulations impose additional obligations related to the protection of personal and health data.

In practice, this necessitates:

• verification of data center locations,
• using appropriate data transfer mechanisms,
• assessing cloud providers for regulatory compliance,
• ensure that access to data by external authorities is controlled and lawful.

HIPAA – The U.S. Clinical Trial Perspective

For clinical trials conducted in the United States or involving data from U.S. patients, HIPAA (the Health Insurance Portability and Accountability Act) is a key component of the regulatory landscape. The HIPAA Privacy and Security Rules define standards for the protection of confidential health information (PHI).

Many HIPAA requirements overlap with ISO/IEC 27001:2022 and GCP principles, particularly in the areas of access control, confidentiality, data integrity, and auditability. In this context, ISO/IEC 27001:2022 can serve as a compliance-supporting framework enabling organizations to simultaneously meet both European and U.S. requirements, provided that appropriate mapping of controls and processes is performed.

Security as an Integral Component of Clinical Trial Quality

Data security is not an add-on to quality – it is an integral part of it. In clinical trials, the protection of patient data, the integrity of records, and regulatory compliance are inseparably linked. ISO/IEC 27001:2022, in combination with GCP guidelines and industry regulations, enables the creation of a coherent, auditable, risk-resistant system that protects both patients and organizations conducting clinical research.

In the era of digitalization, such a holistic approach to data security has become one of the key indicators of organizational maturity in clinical trials.

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