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

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	VI C.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Delegation of monitoring responsibilities

Content

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 to a CRO, FDA regulations (21 CFR 312.52) require the written transfer of any obligations from a sponsor to a CRO and require the CRO to comply with the regulations.38 Although sponsors can transfer responsibilities for monitoring to a CRO(s), they retain responsibility for oversight of the work completed by the CRO(s) that assume this responsibility. Sponsors should evaluate CRO compliance with regulatory requirements and contractual obligations in an ongoing manner. For example, sponsor oversight of monitoring performed by a CRO may include the sponsor’s periodic review of monitoring reports and vendor performance or quality metrics and documented communication between the sponsor and CRO regarding monitoring progress and findings.

Sponsors and CROs should consider additional factors when a sponsor transfers responsibilities for monitoring to a CRO. Sponsors and CROs should prospectively establish a clear understanding of both parties’ responsibilities and of the expectations for the conduct of the transferred obligations. Sponsors should share information with a CRO that may inform decisions a CRO may make regarding the monitoring practices for a trial (e.g., findings of a risk assessment). Sponsors should prospectively evaluate monitoring procedures and monitoring plans developed by a CRO to ensure the monitoring approach is consistent with applicable aspects of the trial. In addition, sponsors and CROs should have processes in place for timely exchange of relevant information (e.g., significant monitoring findings, significant changes in risk for a trial).

38 The regulations for investigational device exemptions (21 CFR part 812) do not contain a provision for delegation to a contract research organization.