Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=IV A. Verification | |RefDocPart=IV A. Verification | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00137-Mon-che ++ TAG-00140-Ris-nRi ++ TAG-00029-Inf-rte ++ TAG-00065-Sou-nΓΌb | ||
| | |RefModule=3 | ||
| | |RefUnit=3.1.1 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 3 β Unit 3.1.1 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| Β | | Β | ||
|- | |- | ||
! Tags | ! Tags | ||
| Β | | [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00140-Ris-nRi|Risk-based monitoring]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00065-Sou-nΓΌb|Source data verification]] | ||
|- | |||
| Β | |||
|- | |||
| Β | |||
|- | |- | ||
! Comment | ! Comment | ||
Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations β 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 β 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 [β¦] A. Identify Critical Data and Processes to be Monitored [β¦] β’ Verification that informed consent was obtained appropriately [...]
