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Building Quality Assurance Into Clinical Trials PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Building Quality Assurance into Clinical Trials".

This medical PowerPoint presentation tells us how quality assurance is a crucial aspect of any clinical trial, as it ensures that the study is conducted in a rigorous and reliable manner. Here are some ways to build quality assurance into clinical trials:

Standard Operating Procedures (SOPs): SOPs are a set of instructions that describe how to conduct specific tasks in a clinical trial. Developing and implementing SOPs can help ensure that all study personnel follow the same procedures, reducing variability and increasing the reliability of the data.
Quality Control (QC) activities: QC activities are designed to identify and address any errors or problems in the study. These activities may include data review and monitoring, source document verification, and audit trails.
Training and Education: Adequate training and education of all study personnel is essential for ensuring that they understand and follow the study protocol and procedures. This includes training on good clinical practice (GCP) guidelines and regulations, as well as specific study-related procedures and protocols.
Site Management: Effective site management is critical for ensuring that the study is conducted in accordance with the protocol and regulations. This includes site initiation, ongoing site monitoring, and close-out activities.
Data Management: Effective data management is essential for ensuring the accuracy and reliability of study data. This includes data entry, data review and monitoring, and data cleaning activities.
External Monitoring: Independent external monitoring is an important aspect of quality assurance. This can include monitoring by a contract research organization (CRO), an independent data monitoring committee (DMC), or a regulatory agency.

By implementing these strategies, clinical trials can build quality assurance into their study design and execution, leading to more reliable and robust data.

Tags : Clinical Trials, quality assurance, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 638 | Downloads : 0

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Transcript

Slide 1-

Building Quality Assurance into Clinical Trials
Slide 2-

Objectives for Today: Define Quality in Research Describe How to Initiate Corrective and Preventative Action Plans Describe Applications for Developing Core Competency for Research.
Slide 3-

Overview
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QC, QA, QMS Quality control (QC) and quality assurance (QA) systems together constitute key quality systems that are parts of quality management systems (QMS) 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 every step Introduction of an independent and objective audit of the QA/QC system and its outcomes
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What is the Purpose of Quality Management ? Patient safety Sponsors Role Identified results of monitor findings Risk Assessment/Evaluations Notifications Decisions Actions
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Possible Road Blocks to Quality Research?
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Building the Framework for Quality
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Clinical Research Quality Is Designed to be Embedded throughout the trial Standard Operating Procedures Know the Protocol Regulatory agency and ethics committee approval Informed Consent Training/Education Adequate monitoring and audits
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Purpose of Quality Control SOP Ensure compliance with SOPs, FDA, sponsor’s protocol and local regulatory bodies Staff training of GCP, SOPs and federal/local regulatory requirements Use Quality Improvement (QI) Program within the USF Division of Research Integrity and Compliance Office Utilize standardized forms and checklists to ensure complete and accurate documentation Conduct periodic internal QAs/ reviews to ensure compliance Deficiencies found through internal QA or sponsor monitoring visits should be corrected Documentation for each study should be reviewed periodically
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ScenarioCorrective Action Plan Required !
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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
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Corrective and Preventive Actions
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Corrective and Preventive Action Potential problems should be identified and steps taken to avoid them Discovery of a problem should trigger an immediate corrective action 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 auditor
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One Small Change Can Lead to Another
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Beyond Compliance to Competency Standardization and Streamlining Training Requirement Developing Team Approach Assigning Acuity to Trial Conduct
Slide 18-

Steps to improve quality in clinical research
Slide 19-

Developing Core Competencies in Clinical Research
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Questions?