EMA · Life Science & Pharma: GxP - CSV & Data Integrity
Guideline on computerised systems and electronic data in clinical trials
Final CSV & Data Integrity · Guideline Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- EMA
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- CSV & Data Integrity
- Sub Category
- Guideline
- Legal weight
- Guidance & Q&A
- Reuse
- EMA reuse
EMA's guideline on computerised systems and electronic data in clinical trials, such as audit trails, cloud services and vendor agreements.
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- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Public consultation started
- Public consultation closed
- Final version adopted by the GCP Inspectors Working Group
- Final version published
In plain English
EMA guideline for clinical trials on computerised systems and electronic data. It covers data integrity, responsibilities, validation, audit trails, user management, security, data migration and archiving, and it includes artificial intelligence. It replaced the 2010 reflection paper on electronic source data.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
This EMA guideline sets expectations for computerised systems and electronic data in clinical trials. Its consultation ran from 18 June to 17 December 2021, and the GCP Inspectors Working Group adopted the final version on 7 March 2023. It replaced the 2010 reflection paper on electronic source data. It took effect six months after publication.
Who and what it applies to
Sponsors, investigators, service providers and others using computerised systems in clinical trials.
What it contains
- Principles
- Data integrity, responsibilities, data and metadata, source data, criticality and risk, data capture, electronic signatures, data protection and validation.
- Computerised systems
- Description, procedures, training, security and access control, and timestamps.
- Data
- Capture, audit trail and its review, sign-off, copying, certified copies, control of data, cloud solutions, backup, contingency, migration, archiving and decommissioning.
- Annexes
- Agreements, computerised systems validation, user management, security, and specific systems including AI.
Key points
- Audit trail review is expected, and metadata review can extend to access logs, event logs and queries.
- Investigators should be shown how to navigate audit trails for their own data.
- Investigators are responsible for data entered under their supervision, and sign-off is confirmation at set milestones.
- Agreements with service providers are needed.
- Cloud solutions, migration and decommissioning are addressed.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Check that vendor qualification covers cloud and eCOA providers.
- Plan decommissioning and data access before a trial starts.
- Train investigators on audit trail access, as the guideline expects.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 10 Mar 2023 | Final version published | Final | Source for Final version published |
| 7 Mar 2023 | Final version adopted by the GCP Inspectors Working Group | Final | Source for Final version adopted by the GCP Inspectors Working Group |
| 17 Dec 2021 | Public consultation closed | Draft | Source for Public consultation closed |
| 18 Jun 2021 | Public consultation started | Draft | Source for Public consultation started |
Related
How other documents connect to this one. Links explained
- Replaces EMA eSource paper (2010)· Compare with EMA eSource paper (2010) Unverified link
- Complemented by EMA notice: CS in trials· Compare with EMA notice: CS in trials Unverified link
Official source
The official text always prevails over anything on this site.
Source: EMA. Summary adapted from the original.
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