Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring |
| Version / Revision | Aug-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Oversight of Clinical Investigations — 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 — Unit 4.3.3 |
| Scope | G |
| Document part | IV A. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Risk-based monitoring, Monitoring, Laboratory, FDA |
Content
IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] Other types of data (e.g., covariates such as concomitant treatments or demographic characteristics, routine laboratory tests performed as part of subject monitoring that do not address protocol specified safety or efficacy endpoints) and processes (e.g., a hospital pharmacy’s storage of an investigational product with no specific critical handling instructions) identified by the sponsor as non-critical often may be monitored less intensively.
There is increasing recognition that some types of errors in a clinical trial are more important than others.31 For example, a low, but non-zero rate of errors in capturing certain baseline characteristics of enrolled subjects (e.g., age, concomitant treatment, or concomitant illness) will not, in general, have a significant effect on study results if the errors are distributed randomly. In contrast, a small number of errors related to study endpoints (e.g., not following protocol-specified definitions) can profoundly affect study results, as could failure to report rare but important adverse events. Based on FDA’s inspection and review experience, infrequent errors in non-critical data are unlikely to alter FDA’s conclusions about whether a product is safe and effective and whether participants’ safety was appropriately monitored. [...]
