Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 VI D.: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 | ||
| | |module=4 | ||
| | |unit=4.3.2 | ||
| | |scope=G | ||
| | |doc_part=VI D. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00137-Mon-che ++ TAG-00257-Sit-zen ++ TAG-00081-Sit-svi ++ TAG-00017-Spo-die ++ TAG-00201-Cli-eSt | ||
|tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00257-Sit-zen|Site staff]], [[Glossary:TAG-00081-Sit-svi|Initiation visit]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]] | |||
Β | |comment=Clinical investigator and site selection and monitoring | ||
|content=VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY | |||
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VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY | |||
[β¦] | [β¦] | ||
D. Clinical Investigator and Site Selection and Initiation | D. Clinical Investigator and Site Selection and Initiation | ||
| Line 50: | Line 17: | ||
In addition to regulatory requirements for CI selection, sponsors should consider factors such as sponsorβs 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. | In addition to regulatory requirements for CI selection, sponsors should consider factors such as sponsorβs 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 sponsorβs 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. | 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 sponsorβs 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. | ||
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Latest revision as of 13:50, 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 4 β 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 |
Content
VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY [β¦] D. Clinical Investigator and Site Selection and Initiation
In addition to regulatory requirements for CI selection, sponsors should consider factors such as sponsorβs 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 sponsorβs 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.
