№ lp_1_2_44290
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Character count: 6249
File size: 50 KB
This document provides guidelines for completing a Corrective and Preventive Action (CAPA) process to address deficiencies identified in clinical trials, focusing on documentation and evaluation methods.
Year:
2019
Region / City:
N/A
Subject:
Quality Assurance, Clinical Trials
Document Type:
Guidance Document
Author:
Bishany & Gorkun
Target Audience:
Institutions involved in clinical trials, investigators, quality assurance personnel
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
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Date:
3/28/2025
Note:
Region / city
Topic:
Corrective and preventive action planning
Document type:
Template
Author:
Lauren Wallace, MS, RAC-Drugs, Sarah Lines, Liz Kissell
Target audience:
Clinical research professionals, IRB, study sponsors
Context description:
Template for creating a corrective and preventive action plan (CAPA) for studies, processes, or systems, detailing actions to address identified issues.
Document type:
Guidance document
Subject area:
Clinical research compliance
Topic:
Corrective and Preventive Action (CAPA)
Applicable field:
Clinical trials
Responsible parties:
Sponsor, monitor, site personnel, principal investigator
Regulatory body referenced:
Institutional Review Board (IRB)
Key components:
Root cause analysis, corrective action, preventive action, follow-up evaluation
Authorship requirements:
Responsible individual or organization
Approval requirements:
Author signature, IRB review
Record retention:
Site regulatory file
Intended use:
Documentation of discrepancies and corrective measures in clinical research
Year:
Not specified
Region / City:
Not specified
Topic:
Reportable Events Management
Document Type:
Template
Institution:
Not specified
Author:
Not specified
Target Audience:
Principal Investigators, Study Team Members
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2015
Region / City:
CRC
Topic:
Clinical Trials, Corrective and Preventive Action
Document Type:
Standard Operating Procedure
Organization:
Clinical Research Center (CRC)
Author:
Not specified
Target Audience:
Clinical Research Personnel
Period of Validity:
Ongoing
Approval Date:
01/01/2015
Effective Date:
01/01/2015
Review/Revision Date:
06/01/2016
Year:
2022
Region / City:
Switzerland
Topic:
Corrective and Preventive Actions in Clinical Trials
Document Type:
Instruction Template
Organization:
Swissmedic
Author:
Not specified
Target Audience:
Clinical trial administrators, quality assurance personnel
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Quality management, corrective actions, preventive actions
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
Carestream Dental
Author:
Not specified
Target Audience:
Employees involved in CAPA activities
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Note:
Year
Theme:
Early Years Services
Document Type:
Corrective Action and Preventive Action Plan
Organization / Institution:
Tusla Early Years Inspectorate
Target Audience:
Registered Providers, Early Years Inspectors
Document Type:
Report template
Subject:
Non-conformities and corrective and preventive actions
Related Document:
Corrective and Preventive Actions
Institution:
USZ / UZH
Scope:
Clinical research and clinical trials
Applicable Roles:
Research team members, Principal Investigators, Sponsor-Investigators, Clinic Directors
Process Sections:
Identification; Evaluation; Root Cause Analysis and Investigation; Action Plan; Implementation of Measures; Follow Up
Reporting Requirement:
Initial notification within 24 hours
CIRS Reference:
CIRS instructions of USZ
CAPA Number:
Provided by pre-defined person
Closure Requirement:
Verification of effectiveness and documented decision
Year:
2022
Region / City:
Paris
Subject:
Photography, War Journalism
Document Type:
Biography
Author:
Mac Caltrider, Matthew Hong
Target Audience:
General public, photography enthusiasts
Period of Activity:
1930s-1950s
Date of Approval:
Not specified
Date of Changes:
Not specified
Context:
Biography of Robert Capa, highlighting his significant contributions to war photography and his influence in the field.
Date:
3/28/2025
Note:
Region / city
Topic:
Corrective and preventive action planning
Document type:
Template
Author:
Lauren Wallace, MS, RAC-Drugs, Sarah Lines, Liz Kissell
Target audience:
Clinical research professionals, IRB, study sponsors
Context description:
Template for creating a corrective and preventive action plan (CAPA) for studies, processes, or systems, detailing actions to address identified issues.
Document type:
Guidance document
Subject area:
Clinical research compliance
Topic:
Corrective and Preventive Action (CAPA)
Applicable field:
Clinical trials
Responsible parties:
Sponsor, monitor, site personnel, principal investigator
Regulatory body referenced:
Institutional Review Board (IRB)
Key components:
Root cause analysis, corrective action, preventive action, follow-up evaluation
Authorship requirements:
Responsible individual or organization
Approval requirements:
Author signature, IRB review
Record retention:
Site regulatory file
Intended use:
Documentation of discrepancies and corrective measures in clinical research
Note:
Year
Theme:
Occupational Health
Document Type:
Training Form
Target Audience:
Workers exposed to cold weather
Year:
2020
Region / City:
Sanger, California
Theme:
Construction, Maintenance, Bidding
Document Type:
Invitation for Bids
Organization:
City of Sanger
Author:
City Clerk, Rebeca Padron
Target Audience:
Contractors, Bidders
Period of Validity:
Until July 29, 2020
Approval Date:
June 26, 2020
Amendment Date:
April 19, 2018
Year:
2022
Region / City:
Switzerland
Topic:
Corrective and Preventive Actions in Clinical Trials
Document Type:
Instruction Template
Organization:
Swissmedic
Author:
Not specified
Target Audience:
Clinical trial administrators, quality assurance personnel
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Region / City:
Sacramento Area
Topic:
RTLS Preventive Maintenance, NIST Calibration, Asset Tracking
Document Type:
Statement of Work (SOW)
Organization / Institution:
UC Davis Health
Author:
UC Davis Health, Supplier
Target Audience:
Supplier, UC Davis Health Staff
Period of Validity:
Effective from Month XX, 2026 to Month XX, 202X
Approval Date:
Month XX, 2026
Amendment Date:
Not specified
Year:
2023
Region / City:
Global
Topic:
Tuberculosis, Healthcare, Public Health
Document Type:
Research Review
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Healthcare providers, Researchers, Public health professionals
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / city:
Nassau, The Bahamas
Subject:
Building Automation Systems, Preventive Maintenance
Document Type:
Statement of Work
Agency / institution:
U.S. Embassy, Nassau
Author:
U.S. Embassy
Target Audience:
Contractors, Facility Maintenance Staff, Technicians
Period of Validity:
Ongoing
Approval Date:
N/A
Amendment Date:
N/A
Note:
Contextual Description
Year:
Not specified
Region / City:
Not specified
Topic:
Quality Control, Food Safety
Document Type:
Procedure
Organization:
Not specified
Author:
Not specified
Target Audience:
Management, Authorized Personnel
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Quality management, corrective actions, preventive actions
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
Carestream Dental
Author:
Not specified
Target Audience:
Employees involved in CAPA activities
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified