This document is part of the broader European Medicines Regulatory Network (EMRN) Data Quality Framework and describes how data quality should be evaluated when data are used in regulatory decision-making, including marketing authorization applications, post-authorization studies, observational research, and studies using healthcare databases or registries.
The document describes several areas related to data quality assessment, including data quality dimensions, data lifecycle considerations, metadata and data provenance, roles and responsibilities of data holders and data users, and documentation expectations when real-world data are used in regulatory submissions. It also addresses the secondary use of data originally collected for clinical practice, administrative, or healthcare system purposes, and describes documentation and governance expectations when such data are used for regulatory analyses.
The framework describes responsibilities of different stakeholders involved in the data lifecycle, including data holders responsible for data collection systems and data management processes, data users responsible for study design and data analysis, and regulators responsible for reviewing the data and the methods used to generate evidence. The document also describes expectations related to data management processes, system reliability, documentation, and metadata describing the origin and transformation of data.
Related Regulations and Guidelines Addressing Data Quality and Data Integrity
Although the EMA Data Quality Framework specifically addresses real-world data and regulatory use of healthcare data sources, data quality and data integrity requirements in medicines regulation are also described across other regulatory guidelines and regulations related to clinical trials, computerized systems, and electronic records.
ICH Guidelines and Good Clinical Practice
International clinical trial standards are described in guidelines published by the
International Council for Harmonisation.
Several ICH guidelines contain requirements related to data recording, documentation, data handling, and clinical trial documentation systems. The most relevant document is ICH E6 Good Clinical Practice, which describes requirements for clinical trial conduct, source data, case report forms, monitoring, documentation, trial master file documentation, quality management systems, and computerized systems used in clinical trials.
Other ICH guidelines also address aspects related to clinical study data and documentation, including guidelines on clinical study design, statistical analysis, clinical study reports, structured electronic protocols, and real-world evidence in regulatory submissions. These guidelines collectively describe expectations for data recording, documentation, data verification, and clinical study documentation used in regulatory submissions.
ICH website:
https://www.ich.org
EU GMP Annex 11 – Computerised Systems
Requirements related to computerized systems used in regulated environments are described in EU GMP Annex 11, Computerised Systems. Although Annex 11 is part of Good Manufacturing Practice regulations, its requirements are frequently referenced for electronic systems used in clinical research, pharmacovigilance, and regulated data management environments.
Annex 11 describes requirements related to system validation, audit trails, access control, data integrity, backup and restore procedures, change control, incident management, and periodic review of computerized systems. These requirements apply to electronic systems used to generate, process, and store regulated data and are often referenced in inspections and regulatory discussions related to electronic systems and data integrity.
FDA Regulations on Electronic Records and Electronic Signatures
In the United States, regulations related to electronic records and electronic signatures are described in 21 CFR Part 11, published by the
U.S. Food and Drug Administration.
This regulation describes requirements for electronic records, electronic signatures, audit trails, system validation, access control, and record retention. The FDA also publishes guidance documents related to electronic source data, real-world evidence, data integrity, and computerized systems used in clinical investigations and regulated environments.
FDA website:
https://www.fda.gov
MHRA Data Integrity Guidance
The Medicines and Healthcare products Regulatory Agency
publishes guidance on Data Integrity and Good Documentation Practice, which describes expectations related to data governance, data lifecycle management, paper and electronic systems, hybrid systems, audit trails, data review procedures, backup and archival processes, and data integrity risk management.
This guidance is often referenced in inspections and regulatory discussions related to data integrity, documentation practices, and computerized systems used in regulated environments.
EMA European Public Assessment Reports
The European Medicines Agency also publishes European Public Assessment Reports (EPAR) for approved medicines. These reports describe the regulatory assessment of clinical trial data, observational studies, registry data, post-authorization studies, and other data sources used in regulatory decision-making.
These reports often include descriptions of study data sources, study design limitations, missing data considerations, and characteristics of data used in regulatory assessments. EPAR reports are publicly available and provide examples of regulatory assessment of clinical and observational data used in medicines regulation.
EPAR database: https://www.ema.europa.eu/en/medicines
Summary of Public Regulatory Documents Related to Data Quality
Data quality, data integrity, documentation, and computerized system requirements in medicines regulation and clinical research are described across multiple regulatory documents and frameworks. These include the EMA Data Quality Framework for real-world data, ICH clinical trial guidelines, EU GMP computerized system requirements, FDA electronic record regulations, MHRA data integrity guidance, and EMA public assessment reports.
These documents describe regulatory expectations related to data recording, documentation, computerized systems, data management processes, and evidence used in medicines regulation and clinical research.
