Following the draft guideline published in June 2021 the final EMA Guideline on computerized systems and data integrity in clinical trials has now been published. The document will become effective 6 months after publication (10 September 2023). The guideline aims in understanding of regulatory expectations to validation, operation, and safe use of Information Technology (IT) systems in clinical trials. It replaces the Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials.
In addition, a new expression is defined: ALCOA+. In addition to the ALCOA+ principles it includes Traceability. This means that data should be traceable throughout the data life cycle. Any changes to the data should be documented as part of the metadata (e.g., audit trail).
Scope
The scope of this guideline is computerised systems, (including instruments, software and 'as a service') used in the creation/capture of electronic clinical data and to the control of other processes with the potential to affect participant protection and reliability of trial data, in the conduct of a clinical trial of investigational medicinal products (IMPs). These include, but may not be limited to the following:
- Electronic medical records, used by the investigator to capture of all health information as per normal clinical practice.
- Tools supplied to investigators/trial participants for recording clinical data via data entry (e.g. electronic clinical outcome assessments [eCOAs]).
- Electronic trial participant data capture devices used to collect ePRO data, e.g. mobile devices supplied to trial participants or applications for use by the trial participant on their own device i.e. bring your own device (BYOD).
- Electronic devices used by clinicians to collect data e.g. mobile devices supplied to clinicians.
- Tools supplied for the automatic capture of data for trial participants such as biometrics, e.g. wearables or sensors.
- eCRFs (e.g. desktop or mobile device-based programs or access to web-based applications), which may contain source data directly entered, transcribed data, or data transferred from other sources, or any combination of these.
- Tools that automatically capture data related to the transit and storage temperatures for investigational medicinal product (IMP) or clinical samples.
- Tools to capture, generate, handle, or store data in a clinical environment where analysis, tests, scans, imaging, evaluations, etc. involving trial participants or samples from trial participants are performed in support of clinical trials (e.g. LC-MS/MS systems, medical imaging and related software).
- eTMFs, which are used to maintain and archive the clinical trial essential documentation.
- Electronic informed consent, for the provision of information and/or capture of the informed consent when this is allowed according to national legislation, e.g. desktop or mobile devicebased programs supplied to potential trial participants or applications for use by the potential trial participants on their BYOD or access to web-based applications.
- Interactive Response Technologies (IRT), for the management of randomisation, supply and receipt of IMP, e.g. via a web-based application.
- Portals or other systems for supplying information from the sponsor to the sites (e.g. investigator brochures (IBs), suspected unexpected serious adverse reactions (SUSARs) or training material), from the sites to the sponsor (e.g. the documentation of the investigator's review of important safety information), or from the sponsor or the site to adjudication committees and others.
- Systems/tools used to conduct remote activities such as monitoring or auditing.
- Other computerised systems implemented by the sponsor holding/managing and/or analysing or reporting data relevant to the clinical trial e.g. clinical trial management systems (CTMS), pharmacovigilance databases, statistical software, document management systems, test management systems and central monitoring software.
- AI used in clinical trials e.g. for trial participant recruitment, determination of eligibility, coding of events and concomitant medication, data clarification, query processes and event adjudication. Requirements to AI beyond the generally applicable expectations to all systems will not be covered in this guideline initially. This may be covered in a future Annex.
