Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007
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| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Computerized Systems Used in Clinical Investigations May-2007 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Computerized Systems Used in Clinical Investigations |
| Version / Revision | May-2007 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance for Industry Computerized Systems Used in Clinical Investigations |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV | G | IV | EN | IV. RECOMMENDATIONS
[...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electr⌠|
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV | G | IV | EN | IV. RECOMMENDATIONS [...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electronic record is the source document. Under 21 CFR ... |
