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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

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|tags_display=[[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]]
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|comment=Risk-based monitoring: verification of informed consent
{| class="gplx-infobox"
|content=IV. RISK-BASED MONITORING
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| G
|-
! Document part
| IV A. Verification
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
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! Tags (original language)
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| Risk-based monitoring: verification of informed consent
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== Content ==
IV. RISK-BASED MONITORING
[…]
[…]
A. Identify Critical Data and Processes to be Monitored
A. Identify Critical Data and Processes to be Monitored
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β€’ Verification that informed consent was obtained appropriately
β€’ Verification that informed consent was obtained appropriately
[...]
[...]
}}

Latest revision as of 13:49, 16 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

Content

IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] β€’ Verification that informed consent was obtained appropriately [...]

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