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

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

References

	Scope	Document part	Language	Preview
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV.	G	III - IV.	EN	III. OVERVIEW OF MONITORING METHODS A. On-Site and Centralized Monitoring 1. On-Site Monitoring 2. Centralized Monitoring B. Examples of Alternative M…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.	G	III B. 3.	EN	III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor sho…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.	G	IV A.	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] Other types of data (e.g., covariates such as concomitant tr…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence	G	IV A. Adherence	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Adherence to protocol eligibility criteria designed to exc…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct	G	IV A. Conduct	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Conduct and documentation of procedures essential to trial…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification	G	IV A. Verification	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Verification that informed consent was obtained appropriat…
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C.	G	VI C.	EN	VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY [...] C. Delegation of Monitoring Responsibilities to a CRO If a sponsor of an IND study delegates …
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D.	G	VI D.	EN	VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY […] D. Clinical Investigator and Site Selection and Initiation In addition to regulatory requiremen…

References

Reference	Scope	Document part	Language	Preview
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C.	G	VI C.	EN	VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY [...] C. Delegation of Monitoring Responsibilities to a CRO If a sponsor of an IND study delegates the responsibility for ensuring proper monitoring ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification	G	IV A. Verification	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Verification that informed consent was obtained appropriately [...]
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence	G	IV A. Adherence	EN	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 ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct	G	IV A. Conduct	EN	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 ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D.	G	VI D.	EN	VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY […] D. Clinical Investigator and Site Selection and Initiation In addition to regulatory requirements for CI selection, sponsors should consider ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV.	G	III - IV.	EN	III. OVERVIEW OF MONITORING METHODS A. On-Site and Centralized Monitoring 1. On-Site Monitoring 2. Centralized Monitoring B. Examples of Alternative Monitoring Techniques 1. Communication with Study ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.	G	III B. 3.	EN	III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor should consider the quantity and types of source ...
Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.	G	IV A.	EN	IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] Other types of data (e.g., covariates such as concomitant treatments or demographic characteristics, routine ...