Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 VI C.: Difference between revisions
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| | |has_document=Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 | ||
| | |module=2 | ||
| | |unit=2.2.1 | ||
| | |scope=G | ||
| | |doc_part=VI C. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00148-Con-rsc ++ TAG-00137-Mon-che ++ TAG-00245-Spo-ten ++ TAG-00320-Foo-eri ++ TAG-00144-Qua-gew | ||
|tags_display=[[Glossary:TAG-00148-Con-rsc|CRO]], [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00144-Qua-gew|Quality assurance]] | |||
Β | |comment=Delegation of monitoring responsibilities | ||
|content=VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY | |||
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VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY | |||
[...] | [...] | ||
C. Delegation of Monitoring Responsibilities to a CRO | C. Delegation of Monitoring Responsibilities to a CRO | ||
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38 The regulations for investigational device exemptions (21 CFR part 812) do not contain a provision for delegation to a contract research organization. | 38 The regulations for investigational device exemptions (21 CFR part 812) do not contain a provision for delegation to a contract research organization. | ||
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Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations β 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 2 β Unit 2.2.1 |
| Scope | G |
| Document part | VI C. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | CRO, Monitoring, Sponsor responsibilities, FDA, Quality assurance |
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 sponsorβs 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 partiesβ 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.
