EMA · Life Science & Pharma: GxP - CSV & Data Integrity
Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials
Superseded Data Integrity · Guideline Last verified: not yet · Source last checked 3 Nov 2026
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- EMA
- Category
- Data Integrity
- Sub Category
- Guideline
- Legal weight
- Guidance & Q&A
- Reuse
- EMA reuse
An older EMA paper on data recorded electronically at source in clinical trials. It has been replaced, and stays here as history.
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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.
- Adopted by the GCP Inspectors Working Group
- Came into effect
- Replaced by the 2023 guideline
In plain English
Earlier EMA reflection paper on electronic source data in clinical trials. EMA has replaced it with the Guideline on computerised systems and electronic data in clinical trials.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
This EMA reflection paper on electronic source data was adopted on 9 June 2010 and came into effect on 1 August 2010. EMA has replaced it with the 2023 guideline on computerised systems and electronic data in clinical trials. It stays on the map as history.
Who and what it applies to
Historic: clinical trial sponsors and investigators.
What it contains
- Status
- Replaced by the 2023 guideline.
Key points
- Do not use it for current requirements.
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.
- Update any procedure that still cites it.
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| 10 Mar 2023 | Replaced by the 2023 guideline | Superseded | Source for Replaced by the 2023 guideline |
| 1 Aug 2010 | Came into effect | Final | Source for Came into effect |
| 9 Jun 2010 | Adopted by the GCP Inspectors Working Group | Final | Source for Adopted by the GCP Inspectors Working Group |
Related
How other documents connect to this one. Links explained
- Replaced by EMA CS clinical trials· Compare with EMA CS clinical 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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