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Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II: Difference between revisions

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|tags_display=[[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
 
|comment=ALCOA principles for source data (FDA)
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 4 — Unit 4.2.3
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! Scope
| G
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! Document part
| II
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! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
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! Tags
| [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
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== Content ==
[…]
Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping.
Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping.
[…]
[…]
}}

Revision as of 12:55, 16 July 2026



Document information
Reference USA FDA Guidance for Industry -

Electronic Source Data in Clinical Investigations Sep-2013

Validity area USA
Scope(s) G
Document name FDA Guidance for Industry -

Electronic Source Data in Clinical Investigations

Version / Revision Sep-2013
Status Current
Document type Official recommendation
Language(s) EN
Description Guidance for Industry Electronic Source Data in Clinical Investigations
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 II
Language EN
Original entry by Florian Adragna
Contributors
Tags Source documents, Data integrity, FDA, Requirements

Content

[…] Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping. […]

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