№ lp_1_20307
File format: docx
Character count: 2714
File size: 60 KB
A template for documenting deficiencies and corrective/preventive actions in the management of reportable events in clinical studies.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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
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
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.
Year:
1982
Region / City:
New South Wales
Topic:
Healthcare risk assessment
Document Type:
Policy
Organization / Institution:
NSW Health
Author:
Chief Executive
Target Audience:
Assessors, Healthcare Professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2022
Region / City:
Canberra
Topic:
Child Protection, Employment-based Child Protection Measures
Document Type:
Policy
Organization / Institution:
Canberra Health Services
Author:
Canberra Health Services Policy Team
Target Audience:
CHS Network Employees and Contractors
Period of Application:
Ongoing
Approval Date:
03 June 2022
Amendment Date:
17/01/2024
Date of Last Update:
11/04/2024
Year:
2026
Region / City:
International
Theme:
Research Ethics
Document Type:
Standard Operating Procedure (SOP)
Organ / Institution:
ISU-IREB
Author:
ISU-IREB SOP Team
Target Audience:
Researchers, IREB Members
Period of Validity:
Ongoing
Approval Date:
2026-02-03
Date of Changes:
N/A
Note:
Year
Year:
Not specified
Region / City:
Not specified
Topic:
Workforce Innovation and Opportunity Act (WIOA), Employment Services
Document Type:
Graphical Guide
Organization:
Department of Labor Employment and Training Administration
Author:
Not specified
Target Audience:
Employment service providers, workforce development professionals
Period of Action:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2024
Region / City:
Australia
Topic:
API specification for reporting situations to ASIC
Document Type:
Technical specification
Organization / Institution:
ASIC
Author:
Scott Collins, Nathaniel Grant, Raj Gunasekaran, Marianne Kerjan
Target Audience:
External organizations and technology teams involved in reporting to ASIC
Period of Validity:
Ongoing
Approval Date:
23/10/2024
Amendment Date:
23/10/2024
Year:
2017
Region / City:
Harare
Subject:
Legal Case
Document Type:
Court Judgment
Institution:
Supreme Court of Zimbabwe
Author:
Unspecified
Target Audience:
Legal Professionals, Judges, Lawyers
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2014
Region / City:
Bulawayo
Topic:
Electoral law, Election petition
Document Type:
Court ruling
Organization / Institution:
Supreme Court of Zimbabwe
Author:
Gwaunza JA, Garwe JA, Guvava J
Target Audience:
Legal professionals, judicial authorities
Period of Effect:
2013-2014
Approval Date:
2014-01-31
Date of Amendments:
None
Note:
Year
Region / City:
Lexington, Kentucky
Subject:
Reportable diseases
Document Type:
Health form
Organization / Institution:
Lexington-Fayette County Health Department
Target Audience:
Healthcare professionals, reporting agencies