Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.: Difference between revisions
From GxPlex
gxplex>GxPlexBot Import from GxPlex Excel |
Migrate to Template:ReferenceData for PageForms (GxPlexBot) |
||
| Line 1: | Line 1: | ||
{{ | {{ReferenceData | ||
| | |has_document=Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 | ||
| | |module=4 | ||
| | |unit=4.3.3 | ||
| | |scope=G | ||
| | |doc_part=III B. 3. | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00065-Sou-nüb ++ TAG-00295-Rem-erp ++ TAG-00137-Mon-che ++ TAG-00124-Cas-Prü ++ TAG-00150-Sou-eUr | |||
|tags_display=[[Glossary:TAG-00065-Sou-nüb|Source data verification]], [[Glossary:TAG-00295-Rem-erp|Remote SDV]], [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00124-Cas-Prü|Case report form]], [[Glossary:TAG-00150-Sou-eUr|Source documents]] | |||
|comment=Alternative monitoring techniques including remote SDV | |||
|content=III. OVERVIEW OF MONITORING METHODS | |||
| | |||
| | |||
III. OVERVIEW OF MONITORING METHODS | |||
B. Examples of Alternative Monitoring Techniques | B. Examples of Alternative Monitoring Techniques | ||
[…] | […] | ||
3. Source Data Verification and Corroboration | 3. Source Data Verification and Corroboration | ||
The sponsor should consider the quantity and types of source data that need to be verified against CRFs or corroborated against other records (e.g., review of medical record to corroborate a subject’s response of “no hospitalizations” since the previous visit on a CRF) during the sponsor’s identification of critical data and processes or in the risk assessment, or both. The sponsor should include a description of the quantity and types of source records to verify or corroborate in the monitoring plan. The sponsor should consider which source records are likely to provide the most meaningful information about a subject’s participation and the CI’s conduct and oversight. For example, for a particular study, there may be minimal benefit in comparing 100% of the source data for each subject to the CRFs for each study visit. Rather, it may be sufficient to compare the most critical data points for a sample of subjects and study visits as an indicator of data accuracy. Similarly, for a particular study, although collection of all concomitant medications, body temperature, and body weight are required by the protocol and are documented in the medical record and transcribed to a CRF, they may not be identified by the sponsor as critical data, because a small error rate in those variables would not affect the outcome of the trial. In the absence of information indicating potential concerns with the data (e.g., sites with data anomalies, inconsistent data), source document verification or corroboration of these non-critical data may not provide significantly useful information to the sponsor. | The sponsor should consider the quantity and types of source data that need to be verified against CRFs or corroborated against other records (e.g., review of medical record to corroborate a subject’s response of “no hospitalizations” since the previous visit on a CRF) during the sponsor’s identification of critical data and processes or in the risk assessment, or both. The sponsor should include a description of the quantity and types of source records to verify or corroborate in the monitoring plan. The sponsor should consider which source records are likely to provide the most meaningful information about a subject’s participation and the CI’s conduct and oversight. For example, for a particular study, there may be minimal benefit in comparing 100% of the source data for each subject to the CRFs for each study visit. Rather, it may be sufficient to compare the most critical data points for a sample of subjects and study visits as an indicator of data accuracy. Similarly, for a particular study, although collection of all concomitant medications, body temperature, and body weight are required by the protocol and are documented in the medical record and transcribed to a CRF, they may not be identified by the sponsor as critical data, because a small error rate in those variables would not affect the outcome of the trial. In the absence of information indicating potential concerns with the data (e.g., sites with data anomalies, inconsistent data), source document verification or corroboration of these non-critical data may not provide significantly useful information to the sponsor. | ||
}} | |||
Revision as of 12:56, 16 July 2026
| 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 | III B. 3. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Source data verification, Remote SDV, Monitoring, Case report form, Source documents |
Content
III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor should consider the quantity and types of source data that need to be verified against CRFs or corroborated against other records (e.g., review of medical record to corroborate a subject’s response of “no hospitalizations” since the previous visit on a CRF) during the sponsor’s identification of critical data and processes or in the risk assessment, or both. The sponsor should include a description of the quantity and types of source records to verify or corroborate in the monitoring plan. The sponsor should consider which source records are likely to provide the most meaningful information about a subject’s participation and the CI’s conduct and oversight. For example, for a particular study, there may be minimal benefit in comparing 100% of the source data for each subject to the CRFs for each study visit. Rather, it may be sufficient to compare the most critical data points for a sample of subjects and study visits as an indicator of data accuracy. Similarly, for a particular study, although collection of all concomitant medications, body temperature, and body weight are required by the protocol and are documented in the medical record and transcribed to a CRF, they may not be identified by the sponsor as critical data, because a small error rate in those variables would not affect the outcome of the trial. In the absence of information indicating potential concerns with the data (e.g., sites with data anomalies, inconsistent data), source document verification or corroboration of these non-critical data may not provide significantly useful information to the sponsor.
