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

Document Information

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

Text

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 [...]