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Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence: Difference between revisions

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{{#set:
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|has_document=Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
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|doc_part=IV A. Adherence
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|tags=TAG-00137-Mon-che ++ TAG-00140-Ris-nRi ++ TAG-00077-Inc-gsk ++ TAG-00033-Pro-oto
{{:Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013}}
|tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00140-Ris-nRi|Risk-based monitoring]], [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
 
|comment=Risk-based monitoring: adherence to eligibility criteria
{| class="gplx-infobox"
|content=IV. RISK-BASED MONITORING
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| G
|-
! Document part
| IV A. Adherence
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|  
|-
! Tags (FR)
|
|-
! Comment
| Risk-based monitoring: adherence to eligibility criteria
|}
 
== Content ==
IV. RISK-BASED MONITORING
[…]
[…]
A. Identify Critical Data and Processes to be Monitored
A. Identify Critical Data and Processes to be Monitored
Line 50: Line 17:
• 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
• 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
[...]
[...]
}}

Latest revision as of 13:49, 16 July 2026



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 [...]

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