Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence
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 3.2.2 |
| Scope | G |
| Document part | IV A. Adherence |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Monitoring, Risk-based monitoring, Inclusion criteria, Protocol |
Content
IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Adherence to protocol eligibility criteria designed to exclude individuals for whom the investigational product may be less safe than the protocol intended and to include only subjects from the targeted study population for whom the test article is most appropriate [...]
