Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Guidance for Industry |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | G |
| Document part | IV A. Verification |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Monitoring, Risk-based monitoring, Informed consent, Source data verification |
| Comment | Risk-based monitoring: verification of informed consent |
Content
IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Verification that informed consent was obtained appropriately [...]
