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

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	III - IV.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Overview of on-site and centralised monitoring methods

Text

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 Site Staff2. Review of Site’s Processes, Procedures, and Records 3. Source Data Verification and Corroboration

IV. RISK-BASED MONITORING A. Identify Critical Data and Processes to be Monitored B. Risk Assessment C. Factors to Consider when Developing a Monitoring Plan D. Monitoring Plan 1. Description of Monitoring Approaches 2. Communication of Monitoring Results 3. Management of Noncompliance 4. Ensuring Quality Monitoring 5. Monitoring Plan Amendments