Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification: Difference between revisions
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{{:Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013}} | {{:Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013}} | ||
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{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| G | | G | ||
|- | |- | ||
! | ! Document part | ||
| IV A. Verification | | IV A. Verification | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (EN) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (original language) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (FR) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Comment | ||
| Risk-based monitoring: verification of informed consent | | Risk-based monitoring: verification of informed consent | ||
|} | |} | ||
== | == Content == | ||
IV. RISK-BASED MONITORING | IV. RISK-BASED MONITORING | ||
[âŚ] | [âŚ] | ||
Revision as of 14:27, 29 June 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring
Guidance for Industry |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | IV A. Verification |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Risk-based monitoring: verification of informed consent |
Content
IV. RISK-BASED MONITORING [âŚ] A. Identify Critical Data and Processes to be Monitored [âŚ] ⢠Verification that informed consent was obtained appropriately [...]
