Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 | ||
| | |module=3 | ||
| | |unit=3.3.2 | ||
| | |scope=G | ||
| | |doc_part=IV A. Conduct | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
 | |tags=TAG-00137-Mon-che ++ TAG-00140-Ris-nRi ++ TAG-00123-Bli-ppe ++ TAG-00145-Ran-ute | ||
= | |tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00140-Ris-nRi|Risk-based monitoring]], [[Glossary:TAG-00123-Bli-ppe|Blinding]], [[Glossary:TAG-00145-Ran-ute|Randomisation]] | ||
|comment=Risk-based monitoring: conduct of randomisation procedures | |||
 | |content=IV. RISK-BASED MONITORING | ||
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IV. RISK-BASED MONITORING | |||
[âŚ] | [âŚ] | ||
A. Identify Critical Data and Processes to be Monitored | A. Identify Critical Data and Processes to be Monitored | ||
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⢠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 | ⢠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 | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations â 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 â Unit 3.3.2 |
| Scope | G |
| Document part | IV A. Conduct |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Monitoring, Risk-based monitoring, Blinding, Randomisation |
Content
IV. RISK-BASED MONITORING [âŚ] A. Identify Critical Data and Processes to be Monitored [âŚ] ⢠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 [...]
