Confidently Compliant? Considerations for Industry Players to Meet the New EMA Guideline
By: Vesta Marciulioniene, Director Global Regulatory Clinical Services, ICON Biotech
Jo Hulbert, Executive Director Global Regulatory Clinical Services, ICON Biotech
Confidently Compliant? Considerations for Industry Players to Meet the New EMA Guideline
By: Vesta Marciulioniene, Director Global Regulatory Clinical Services, ICON Biotech
Jo Hulbert, Executive Director Global Regulatory Clinical Services, ICON Biotech
EMA’s new framework involves globally applicable standards for computerised systems and electronic data in clinical trials.
Any pharmaceutical or biotech company seeking a medicinal product marketing authorisation in the European Union (EU) was recently under pressure to implement the requirements of the European Medicines Agency (EMA) Guideline on Computerised Systems and Electronic Data in Clinical Trials that became effective on 9 September 2023. The guideline introduced a framework of standards for computerised systems and electronic data in clinical trials and drove many companies to reassess whether they fully met those standards by the effective date.
The Purpose at a Glance
To ensure the integrity, reliability and regulatory compliance of computer systems in clinical trials, the EMA has established a guideline that governs their use and addresses the complexity of these computerised systems. The guideline consolidates expectations on the use of computerised systems, the collection and use of electronic data, and provides a framework to be upheld by sponsors, investigators and their service providers.
In alignment with the ICH GCP, the responsibility for the proper use of computerised systems and management of electronic data in clinical research is assigned to two key stakeholders:
- Investigators and their institutions, laboratories and other technical departments or clinics
- Sponsors that directly or via service providers supply, store and/or manage and operate computerised systems (software and hardware) and the records generated by them
Understanding vs Underestimating the Scope
Prior to the implementation date, there was some confusion around the industry as to the scope of the guideline and its impacts. As a result, we sought a clarification on the definition of ‘clinical data’ as represented in the document. The EMA confirmed to ICON that “the scope of the guideline should not be considered to be restricted to systems handling data of trial participants, and we would encourage a more global reading and interpretation”. Thus, the scope of this guideline broadly extends across computerised system and electronic data use and management in clinical trials. Therefore, any assumption that the scope is limited to clinical data generated at investigative sites is an underestimation of the scope and may have resulted in noncompliance if not properly assessed and addressed.
Building Confidence in EMA Compliance
One of the key aspects of the guideline is the validation of computerised systems. It outlines the requirements for establishing the reliability and accuracy of these systems, ensuring that they consistently perform their intended functions. By maintaining comprehensive documentation of system specifications, testing protocols and maintenance procedures, and by implementing thorough validation processes, sponsors should achieve a degree of confidence in the integrity of the data generated by these systems and their compliance with the EMA guidelines.
With the paramount importance of data integrity and security in clinical research, it comes with no surprise that the EMA guideline places great emphasis on appropriate access controls, user authentication and data encryption to protect against unauthorised access and data breaches. The guideline also stresses the importance of audit trails, ensuring transparency and traceability of data modifications.
Considerations Beyond Technology
When thinking about computerised systems and electronic data, some may be tempted to believe that the guideline pertains purely to technical, information technology (IT) related aspects. However, we encourage you to think about it through the lenses of several key perspectives to ensure thorough compliance:
- Processes: Do your standard operating procedures (SOPs) and other controlled documents embed and comply to the requirements of this guideline? Do they allow and guide the relevant process roles to make appropriate assessment on the systems and electronic data or guide them on relevant procedures to be used for electronic data access and use?
- People: Do you have any people in impacted roles who need to have a specific level of awareness of this guideline, its requirements, and the extent to which it impacts their roles? What level of training and change management is needed?
- Clinical trial project delivery: How does the guideline impact your delivery in ongoing or new clinical trials? What considerations should apply to be in compliance for any investigational product targeting a marketing authorisation in EU?
- Vendors: Do your vendors comply with the requirements of this guideline and how that compliance is ensured and overseen?
- Budgets and other financial implications: Does the adherence to this guideline impact costs on clinical research projects or require investments by the company in technology and system updates, process updates, people training?
- Investigators: How do we qualify investigators ensuring appropriate electronic system suitability, access and use? How do we define source data agreements and access to source data and EMR source data at investigative sites?
These are some key considerations where each clinical research related function within complex, matrix-based organisations — whether a sponsor, CRO or vendor — need to assess their daily interface with systems and electronic data. The recently implemented guideline encourages all impacted stakeholders to think about clinical data as both “data derived from a trial participant and any other trial related data handled in e-systems for the purposes of conducting and reporting a clinical trial, and relevant for the clinical trial”, as explained by EMA in the clarification letter to ICON.
Compliance with New EMA Guidelines
The clinical research industry has had line of sight on the guideline and its implications since the first draft was released in September 2021. Some have been working across their organisational functions to assess the impacts and have ensured effective and timely implementation of this guideline. An adequate assessment and mitigation of the ultimate impacts of this guidance will be a significant undertaking given its recent implementation and the complex, multilayered nature of clinical research. ICON recommends clients, investigators and other stakeholders conduct assessments of their clinical trial computerised systems and electronic data use, access and management, and advocates for raising the awareness of this new guideline globally.
Compliance of computerised systems and electronic data to the regulatory standards is critical for clinical trial data reliability and protection of patient safety and rights. As the new EMA guidance has already come into effect as of 9 September, everyone in the industry should be confident in their compliance.
Register for our 28 November webinar on Clinical Trial Computerised Systems and Electronic Data.
ABOUT Vesta Marciulioniene
Vesta Marciulioniene is the Director of Global Regulatory Clinical Services at ICON Biotech. Vesta has 21 years’ experience in the clinical research industry. She has led multifunctional teams regionally and globally, including start-up operations, clinical operations, clinical delivery, flexible solutions, document review, site ID and regulatory. Vesta brings significant start-up and regulatory experience, in addition to having versatile proficiency in global initiatives, clinical trial service centralisation and organisational change management.
Within ICON, Vesta has been at the forefront of the implementation of the EMA Guideline on computerised systems and electronic data in clinical trials across multiple functions in the organisation.
ABOUT Jo Hulbert
Jo Hulbert is the Executive Director of Global Regulatory Clinical Services at ICON Biotech. Jo has 25+ years of regulatory experience. Since joining the industry, she has gained in-depth experience in the areas of regulatory affairs, product development, clinical trials, pharmacovigilance, and quality assurance (GCP, GVP, IP-GMP and regulatory).
She specialises in managing all regulatory aspects of global clinical trials and MAAs and provides a broad range of strategy and consultancy for pharmaceuticals, biologicals, medical devices, and advanced therapies, with a special interest in innovation, DCTs, and transformation. Jo has worked in a variety of therapeutic areas and technologies ranging from known active products to biological and advanced therapy medicinal products (ATMPs)/genetically modified organisms (GMOs) and from oral dosage forms to topicals and transdermals.
