Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring Aug-2013
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| 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
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference: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 the responsibility for ensuring proper monitoring ... |
| Reference: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 appropriately [...] |
| Reference: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 exclude individuals for whom the investigational ... |
| Reference: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 trial integrity, such as ensuring the study blind is ... |
| Reference: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 requirements for CI selection, sponsors should consider ... |
| Reference: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 Monitoring Techniques 1. Communication with Study ... |
| Reference: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 should consider the quantity and types of source ... |
| Reference: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 treatments or demographic characteristics, routine ... |
