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Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4: Difference between revisions

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! colspan="2" class="gplx-infobox-header" | Reference Details
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| Module 4 — Unit 4.2.3
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! Document part
| 4.4
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| EN
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! Original entry by
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| Definition of source data (data integrity context)
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== Content ==
4.4. Source data
The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital records, clinical and office charts, laboratory notes. Other examples are emails, spreadsheets, audio and/or video files, images, and tables in databases.
The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital records, clinical and office charts, laboratory notes. Other examples are emails, spreadsheets, audio and/or video files, images, and tables in databases.
The location of source documents and the associated source data they contain, should be clearly identified at all points within the data capture process.
The location of source documents and the associated source data they contain, should be clearly identified at all points within the data capture process.
[...]
[...]
}}

Revision as of 12:55, 16 July 2026



Document information
Reference EU EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in clinical trials 2023

Validity area EU
Scope(s) G
Document name EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in clinical trials

Version / Revision 2023
Status Current
Document type Official guideline
Language(s) EN
Description EMA/INS/GCP/112288/2023

Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 4 — Unit 4.2.3
Scope G
Document part 4.4
Language EN
Original entry by Florian Adragna
Contributors
Tags Source documents, Definition, Data integrity

Content

4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital records, clinical and office charts, laboratory notes. Other examples are emails, spreadsheets, audio and/or video files, images, and tables in databases. The location of source documents and the associated source data they contain, should be clearly identified at all points within the data capture process. [...]

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