Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013: Difference between revisions
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Latest revision as of 14:15, 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 III - IV. | G | III - IV. | EN | III. OVERVIEW OF MONITORING METHODS
A. On-Site and Centralized Monitoring 1. On-Site Monitoring 2. Centralized Monitoring B. Examples of Alternative M⦠|
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 III B. 3. | G | III B. 3. | EN | III. OVERVIEW OF MONITORING METHODS
B. Examples of Alternative Monitoring Techniques [β¦] 3. Source Data Verification and Corroboration The sponsor shoβ¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 IV A. | G | IV A. | EN | IV. RISK-BASED MONITORING
[β¦] A. Identify Critical Data and Processes to be Monitored [β¦] Other types of data (e.g., covariates such as concomitant trβ¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence | G | IV A. Adherence | EN | IV. RISK-BASED MONITORING
[β¦] A. Identify Critical Data and Processes to be Monitored [β¦] β’ Adherence to protocol eligibility criteria designed to excβ¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct | G | IV A. Conduct | EN | IV. RISK-BASED MONITORING
[β¦] A. Identify Critical Data and Processes to be Monitored [β¦] β’ Conduct and documentation of procedures essential to trialβ¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification | G | IV A. Verification | EN | IV. RISK-BASED MONITORING
[β¦] A. Identify Critical Data and Processes to be Monitored [β¦] β’ Verification that informed consent was obtained appropriatβ¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 VI C. | G | VI C. | EN | VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY
[...] C. Delegation of Monitoring Responsibilities to a CRO If a sponsor of an IND study delegates β¦ |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013 VI D. | G | VI D. | EN | VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY
[β¦] D. Clinical Investigator and Site Selection and Initiation In addition to regulatory requiremenβ¦ |
