--- title: EMA Publishes Guideline on Computerized Systems and Electronic Data in Clinical Trials description: Focus on the important updates of the publishes Guideline on Computerized Systems and Electronic Data for Clinical Trials. image: https://blog.pqegroup.com/hubfs/Guidelines%20on%20CS%20and%20Electronic%20Data%20in%20Clinical%20Trials_Site%20Banner-1.jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![](https://blog.pqegroup.com/hubfs/blank-user.png) Marianna Esposito GCP Compliance Operations Manager, GCP Auditor & Local Equity Partner @PQE Group # **EMA Publishes Guideline on Computerized Systems and Electronic Data in Clinical Trials** [Clinical Research](https://blog.pqegroup.com/tag/clinical-research)   ## ABSTRACT The finalized guideline, set to take effect on September 10, 2023, provides regulatory expectations for the validation, operation, and safe use of IT systems in clinical trials. It replaces the previous "Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials." Notably, the guideline includes previously overlooked [computerized systems](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#CSV) that now require validation, such as portals, trial recruitment databases, and cloud solutions. It introduces [ALCOA++](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Alcoa) principles, emphasizing traceability throughout the[data life cycle](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Data). The guideline covers data retention, database decommissioning, and the importance of defining [roles and responsibilities](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Roles). [Audit trails](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Audit) play a significant role, requiring secure, timestamped, and computer-generated documentation. [Six annexes](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Annex) cover agreements, validation, user management, security, specific systems, and clinical systems. [Annex 6](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Six) addresses implementing clinical systems in trial sites to standardize their usage. [The guideline promotes](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials#Conclude) data integrity, transparency, and adherence to regulatory requirements in clinical research.  The draft guideline, initially published in June 2021, has now been finalized and officially published. It will come into effect six months after publication, starting on September 10, 2023. The guideline aims to provide a clear understanding of regulatory expectations for the validation, operation, and safe use of IT systems in clinical trials, replacing the previous "Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials."   One notable aspect of the guideline is the inclusion of previously overlooked computerized systems that now require validation. These systems include portals, trial recruitment databases, cloud solutions, and more, highlighting their importance in maintaining Good Practice (GxP) standards.  A significant addition to the guideline is the introduction of ALCOA++ principles. Building upon the established ALCOA+ principles, the "+ +" signifies the added element of traceability. This means that data must be traceable throughout its life cycle, with any changes properly documented as metadata, including an audit trail.  Data retention and database decommissioning are also covered in the guideline. EU regulations require that the database be available for 25 years, and even after the system is locked, the flat files should remain accessible for an additional 25 years during archiving.  The guideline highlights the importance of clearly defining roles and responsibilities in clinical trials. Investigators, their institutions, laboratories, technical departments, clinics, and sponsors all have specific responsibilities regarding the handling and management of data within computerized systems. Sponsors may directly manage these systems or utilize service providers to collect and store data on their behalf.  Regarding audit trails, the guideline emphasizes their importance in documenting the original creation and subsequent modifications of electronic data. The audit trail should be secure, computer-generated, and timestamped. Procedures for risk-based trial-specific audit trail reviews should be in place, and data review should focus on critical data. Both manual and technological review methods can be employed to facilitate the review of large datasets.  The guideline also includes six annexes covering various aspects, such as agreements, computerized systems validation, user management, security measures, additional considerations for specific systems (e.g., IRT systems, electronic informed consent), and clinical systems (e.g., user management, trial-specific data acquisition tools, archiving).  Annex 6 added in the final version addresses the implementation of clinical systems in trial sites. This added document, aims to standardize the use of computerized systems in facilities such as hospitals, which may be unfamiliar with their usage. By promoting data integrity, this annex seeks to ensure consistent practices across all clinical trials.  Clear responsibilities have been defined for investigators (researchers) and sponsors (pharmaceutical companies or their authorized service providers) regarding the management, operation, and recording of data within computerized systems. Investigators are also expected to review and audit their own data for any changes, further reinforcing data integrity.  The release of this guideline represents a notable advancement in the standardization of computerized systems and the preservation of data integrity within clinical trials. Successfully implementing these guidelines will enhance transparency, reliability, and adherence to regulatory requirements in the realm of clinical research.  ![Guidelines on CS and Electronic Data in Clinical Trials_Site Banner](https://blog.pqegroup.com/hubfs/Guidelines%20on%20CS%20and%20Electronic%20Data%20in%20Clinical%20Trials_Site%20Banner.jpg) ## Need Support with Clinical Trials? We have developed a dedicated service just for you, to assist your business in the compliance and the operations related to clinical studies. Visit our dedicated page to [Clinical Research](https://www2.pqegroup.com/clinical-research-services/), and explore the entire scope of our service's. [Connect with us](https://www2.pqegroup.com/contact-us/) [Explore services](https://www2.pqegroup.com/clinical-research-services/) #### More on this topic [Clinical Research ![Orchestrating Innovation: Aligning Science, Strategy, and Market Success](https://blog.pqegroup.com/hubfs/Orchestrating%20Innovation_Blog%20(1)-1.webp)](https://blog.pqegroup.com/clinical-research/orchestrating-innovation-aligning-science-strategy-and-market-success) 02 Jul 2026 ## [Orchestrating Innovation: Aligning Science, Strategy, and Market Success The future of healthcare belongs to those who can turn innovation into impact. Read more.](https://blog.pqegroup.com/clinical-research/orchestrating-innovation-aligning-science-strategy-and-market-success) [Clinical Research ![How ICH E6 Revision 3 Is Redefining Our Understanding of Clinical Trials](https://blog.pqegroup.com/hubfs/BANNER-How%20ICH%20E6%20Revision%203%20%20Is%20Redefining%20Our%20Understanding%20%20of%20Clinical%20Trials%20_1_1_1.jpg)](https://blog.pqegroup.com/how-ich-e6-revision-3-is-redefining-our-understanding-of-clinical-trials) 10 Jun 2025 ## [How ICH E6 Revision 3 Is Redefining Our Understanding of Clinical Trials Discover how ICH E6(R3) is redefining clinical trials with a modern, flexible, and patient-centric approach](https://blog.pqegroup.com/how-ich-e6-revision-3-is-redefining-our-understanding-of-clinical-trials) [Clinical Research ![Why Small Pharma Companies Rely on CROs and What They Expect](https://blog.pqegroup.com/hubfs/Clinical%20Research_Baroldi_Blog%20Banner.jpg)](https://blog.pqegroup.com/clinical-research/why-small-pharma-companies-rely-on-cros-and-what-they-expect) 20 Feb 2025 ## [Why Small Pharma Companies Rely on CROs and What They Expect Small pharma companies rely on CROs for expertise, cost-effectiveness, flexibility, and strong communication in clinical trials.](https://blog.pqegroup.com/clinical-research/why-small-pharma-companies-rely-on-cros-and-what-they-expect) ![new PQE logo white tagline](https://blog.pqegroup.com/hubfs/new%20PQE%20logo%20white%20tagline.png) ISO 9001 Certified compliance services provider since 1998.   ![Logo ISO 9001](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20ISO%209001.png?width=125&name=Logo%20ISO%209001.png)   - Discover PQE - [Work with PQE](https://www2.pqegroup.com/careers/) - [Locations](https://www2.pqegroup.com/contact-us/#locations) - [About](https://www2.pqegroup.com/about/) - [Blog](https://blog.pqegroup.com/) - Useful Links - [Privacy Notice](https://www2.pqegroup.com/privacy-notice/) - [Cookie Policy](https://www2.pqegroup.com/cookie-policy/) - [Model of Organization](https://www2.pqegroup.com/model-of-organization/) - [Ethical Code](https://www2.pqegroup.com/ethical-code/) English - [English](https://blog.pqegroup.com/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials) - [Deutsch](https://blog.pqegroup.com/de/klinische-forschung/ema-leitlinie-zu-computergestutzten-systemen-und-elektronischen-daten-in-klinischen-studien) - [Español - España](https://blog.pqegroup.com/es-es/investigacion-clinica/ema-publica-guia-sobre-sistemas-informatizados-y-datos-electronicos-en-ensayos-clinicos) - [Español - México](https://blog.pqegroup.com/es-mx/investigacion-clinica/ema-publica-guia-sobre-sistemas-computarizados-y-datos-electronicos-en-ensayos-clinicos) - [Français](https://blog.pqegroup.com/fr/recherche-clinique/données-électroniques-dans-les-essais-cliniques) - [Polski](https://blog.pqegroup.com/pl/badania-kliniczne/ema-publikuje-wytyczne-dotyczące-systemów-komputerowych-i-elektronicznych-danych-w-badaniach-klinicznych) - [Português - Brasil](https://blog.pqegroup.com/pt-br/pesquisa-clinica/ema-publica-diretriz-sobre-sistemas-computadorizados-e-dados-eletronicos-em-ensaios-clinicos) - [עברית](https://blog.pqegroup.com/he/clinical-studies/ema-publishes-guideline-on-computerized-systems-and-electronic-data-in-clinical-trials) CHANGE LANGUAGE Copyright **2024** | Proudly powered by **PQE Group Creative Team** [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://blog.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)