Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.: Difference between revisions
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| | |has_document=Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 | ||
| | |module=4 | ||
| | |unit=4.2.3 | ||
| | |scope=G | ||
| | |doc_part=III 4. | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00064-Ele-eUn ++ TAG-00122-Aud-Aud ++ TAG-00124-Cas-PrΓΌ ++ TAG-00150-Sou-eUr ++ TAG-00320-Foo-eri | ||
|tags_display=[[Glossary:TAG-00064-Ele-eUn|Electronic records]], [[Glossary:TAG-00122-Aud-Aud|Audit trail]], [[Glossary:TAG-00124-Cas-PrΓΌ|Case report form]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00320-Foo-eri|FDA]] | |||
Β | |comment=Modifications and corrections to electronic source data | ||
|content=III. Electronic Source Data | |||
| | |||
| | |||
Β | |||
III. Electronic Source Data | |||
[β¦] | [β¦] | ||
4. Modifications and Corrections | 4. Modifications and Corrections | ||
Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified and/or corrected data elements must have data element identifiers that reflect the date, time, originator and reason for the change, and must not obscure previous entries.11 A field should be provided allowing originators to describe the reason for the change (e.g., transcription error). Automatic transmissions should have traceability and controls via the audit trail to reflect the reason for the change. | Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified and/or corrected data elements must have data element identifiers that reflect the date, time, originator and reason for the change, and must not obscure previous entries.11 A field should be provided allowing originators to describe the reason for the change (e.g., transcription error). Automatic transmissions should have traceability and controls via the audit trail to reflect the reason for the change. | ||
[...] | [...] | ||
}} | |||
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 β Unit 4.2.3 |
| Scope | G |
| Document part | III 4. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Electronic records, Audit trail, Case report form, Source documents, FDA |
Content
III. Electronic Source Data [β¦] 4. Modifications and Corrections Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified and/or corrected data elements must have data element identifiers that reflect the date, time, originator and reason for the change, and must not obscure previous entries.11 A field should be provided allowing originators to describe the reason for the change (e.g., transcription error). Automatic transmissions should have traceability and controls via the audit trail to reflect the reason for the change. [...]
