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

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== Document Information ==
{{:Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013}}
{{:Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013}}


== Reference Details ==
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! scope="row" style="width:200px;" | Document part
! Document part
| IV A. Conduct
| IV A. Conduct
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|-
! scope="row" style="width:200px;" | Language
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| EN
| EN
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! scope="row" style="width:200px;" | Original entry by
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| Florian Adragna
| Florian Adragna
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! scope="row" style="width:200px;" | Contributors
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! scope="row" style="width:200px;" | Tags (EN)
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! scope="row" style="width:200px;" | Tags (FR)
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! scope="row" | Comment
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| Risk-based monitoring: conduct of randomisation procedures
| Risk-based monitoring: conduct of randomisation procedures
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== Text ==
== Content ==
IV. RISK-BASED MONITORING
IV. RISK-BASED MONITORING
[…]
[…]

Revision as of 14:27, 29 June 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
Scope G
Document part IV A. Conduct
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Risk-based monitoring: conduct of randomisation procedures

Content

IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Conduct and documentation of procedures essential to trial integrity, such as ensuring the study blind is maintained, both at the site level and at the sponsor level, as appropriate, referring specified events for adjudication, and allocation concealment [...]

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