• Define Quality in Research
• Describe How to Initiate Corrective and
• Describe Applications for Developing Core
Competency for Research.
Components of Quality Research
Developing Core Competency in Clinical
QC, QA, QMS
• Quality control (QC) and quality assurance (QA) systems
together constitute key quality systems that are parts of
• QA defines the standards to be followed in order to meet
the quality requirements for a clinical trial
• QC ensures that these defined standards are followed at
• Introduction of an independent and objective audit of the
QA/QC system and its outcomes
Quality Management ?
Identified results of monitor findings
Risk Assessment/Evaluations
Possible Road Blocks to Quality
Building the Framework for Quality
Clinical Research Quality Is Designed to be
Embedded throughout the trial
• Know the Protocol
• Regulatory agency and ethics committee
• Adequate monitoring and audits
Purpose of Quality Control SOP
1. Ensure compliance with SOPs, FDA, sponsor’s protocol and local regulatory
2. Staff training of GCP, SOPs and federal/local regulatory requirements
3. Use Quality Improvement (QI) Program within the USF Division of Research
4. Utilize standardized forms and checklists to ensure complete and accurate
5. Conduct periodic internal QAs/ reviews to ensure compliance
6. Deficiencies found through internal QA or sponsor monitoring visits should
7. Documentation for each study should be reviewed periodically
Corrective Action Plan Required !
Define CAPA
Correction Action is any action taken to
eliminate the cause of an existing non
conformity, defect or undesirable situation in
order to prevent reoccurrence.
Preventative Action taken to eliminate the cause
of an potential nonconformity
- Potential problems should be identified and steps
taken to avoid them
- Discovery of a problem should trigger an immediate
Development of a plan to prevent recurrences. A
reevaluation of the system should be performed to
ascertain how the problem occurred-Root cause
- Documentation to avoid any questions from an
One Small Change Can Lead to Another
Beyond Compliance to
Standardization and Streamlining
Developing Team Approach
Assigning Acuity to Trial Conduct
Steps to improve quality in clinical research
Address Human Factor
System and Standardization
Developing Core Competencies in Clinical Research
Scientific Concept and
Study and Site
Ethical and Safety
Communication and Team
DELPHI DELCO ELECTRONICS SYSTEMS DE FOR 914.01A 5-Phase Corrective/Preventive Action Report
Section_17_Rev7-03.doc
HIRA: Introduction of DMI - Management Platform for Human
Corrective vs. Preventive Action
LO Wind maintenance technician_KPA2
LEC1-Maintenance Definition