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

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
Module	Module 4 — Unit 4.3.2
Scope	G
Document part	VI D.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Monitoring, Site staff, Initiation visit, Sponsor, Clinical investigation
Comment	Clinical investigator and site selection and monitoring

Content

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 factors such as sponsor’s previous experience with the CI or site, workload of the CI and study staff, and resource availability at the study site during CI and site selection. Site initiation is a critical study activity that often involves sponsor personnel from a range of disciplines, including monitors. Key components of site initiation include ensuring the CIs and site staff understand their responsibilities, including applicable regulatory requirements as well as study processes and procedures, including the sponsor’s processes for monitoring the investigation. Communication and documentation tools for monitoring discussed in this guidance can also be used for site selection and initiation activities.