Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations β€” A Risk-Based Approach to Monitoring Aug-2013 III - IV.: Difference between revisions

From GxPlex

Jump to: navigation, search
← Older editNewer edit β†’
m 1 revision imported
imported>GxPlexBot
Import from GxPlex Excel
Line 4: Line 4:
|RefDocPart=III - IV.
|RefDocPart=III - IV.
|RefLanguage=EN
|RefLanguage=EN
|RefTagsEN=
|RefTags=TAG-00137-Mon-che ++ TAG-00293-Cen-sMo ++ TAG-00065-Sou-nΓΌb ++ TAG-00338-Met-odi ++ TAG-00327-Exa-spi
|RefTagsOriginal=
|RefModule=4
|RefTagsFR=
|RefUnit=4.3.3
}}
}}


Line 14: Line 14:
|-
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 4 β€” Unit 4.3.3
|-
|-
! Scope
! Scope
Line 30: Line 33:
| Β 
| Β 
|-
|-
! Tags (EN)
! Tags
| Β 
| [[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]]
|-
! Tags (original language)
| Β 
|-
! Tags (FR)
| Β 
|-
|-
! Comment
! Comment

Revision as of 17:29, 15 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
Comment Overview of on-site and centralised monitoring methods

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 Site’s 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

Retrieved from "https://gxplex.org/index.php?title=Reference:USA_FDA_Guidance_for_Industry_-_Oversight_of_Clinical_Investigations_β€”_A_Risk-Based_Approach_to_Monitoring_Aug-2013_III_-_IV.&oldid=15134"