Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 III - IV.: 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=4 | ||
| | |unit=4.3.3 | ||
| | |scope=G | ||
| | |doc_part=III - IV. | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00137-Mon-che ++ TAG-00293-Cen-sMo ++ TAG-00065-Sou-nΓΌb ++ TAG-00338-Met-odi ++ TAG-00327-Exa-spi | ||
|tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00293-Cen-sMo|Centralised monitoring]], [[Glossary:TAG-00065-Sou-nΓΌb|Source data verification]], [[Glossary:TAG-00338-Met-odi|Methodology]], [[Glossary:TAG-00327-Exa-spi|Examples]] | |||
Β | |comment=Overview of on-site and centralised monitoring methods | ||
|content=III. OVERVIEW OF MONITORING METHODS | |||
| | |||
| | |||
Β | |||
III. OVERVIEW OF MONITORING METHODS | |||
A. On-Site and Centralized Monitoring | A. On-Site and Centralized Monitoring | ||
1. On-Site Monitoring | 1. On-Site Monitoring | ||
| Line 59: | Line 29: | ||
4. Ensuring Quality Monitoring | 4. Ensuring Quality Monitoring | ||
5. Monitoring Plan Amendments | 5. Monitoring Plan Amendments | ||
}} | |||
Revision as of 12:56, 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 4.3.3 |
| Scope | G |
| Document part | III - IV. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Monitoring, Centralised monitoring, Source data verification, Methodology, Examples |
Content
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 Siteβs 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
