Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II: Difference between revisions
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| | | [[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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Revision as of 17:29, 15 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 |
| Comment | ALCOA principles for source data (FDA) |
Content
[…] Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping. […]
