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Quality Systems Compliance Assessment. Office of Human Research Protection Georgia Health Sciences University. Research Compliance. Quality Systems approach to ensuring all aspects of research conduct and compliance are addressed. OLD AUDIT vs. QUALITY SYSTEMS ASSESSMENT. Old Audit - PowerPoint PPT Presentation
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Office of Human Research Protection Georgia Health Sciences University
Quality Systems approach to ensuring all aspects of research conduct and compliance are addressed
Old Audit◦ Review of all records◦ More of a monitoring
visit◦ Focused on finding
errors
New Assessment◦ Focused on PI oversight
and involvement◦ Looking for trends◦ Focus on compliance and
educating study staff
Level 1◦ Management Controls◦ Personnel Controls◦ Facility Controls
Level 2◦ Investigational product control◦ Safety controls◦ Records, documents and
revision controls Level 3
◦ Corrective and preventative action controls
Facility Facility ControlsControls
InvestigationalInvestigationalProductProductControlsControls
Records,Records, Documents, & Documents, &
Revision ControlsRevision Controls
SafetySafetyControlsControls
Personnel Personnel ControlsControls
Corrective &Corrective &PreventivePreventive
ActionsActions
ManagementManagementControlsControls
The PI is ultimately responsible for the conduct of the study and must take an active role in ensuring the study is conducted in compliance with all applicable regulations, policies, and laws. Responsibilities include, but are not limited to:
Appropriate delegation of study related tasks Adequate supervision of the conduct of the research PI should ensure there are standard operating
procedures for all aspects of the study specific to the research site
The PI should provide management oversight and supervision
The PI must ensure:Education, training, and expertise of investigative staffTraining measures taken when nonconformities are identifiedOngoing training efforts and study-specific trainingPersonnel involvement and impact on compliance
External facility◦ Outside
laboratories Internal facility
◦ Equipment ◦ Space
Systems to control Investigational products (IP) including the areas of:
Receiving Storing and security measures/ access controls Dispensing Overall accountability Use Return Reconciliation Process for approving personnel
Adverse event reporting Medical oversight
◦ Physician involvement in (inclusion/exclusion)
◦ Appropriate or over delegation Laboratory and specialty testing Human research subject safety/
ethics◦ IRB approval for all changes made to
protocol Protocol deviation management
The PI must ensure:Data collection, including source documentation and integrity and investigator data management processRegulatory documents are present and organizedControl to ensure security and confidentiality of the recordsDelegation of Authority and training records (to verify record/data accuracy )Documentation of training for research team
Internal quality assurance and quality control Monitoring process Internal assessment capabilities
May see more request for documentation of PI involvement◦ Training records ◦ Meetings documentation◦ E-mail correspondence
Audits will not review every subject record◦ Research team will be responsible for finding
additional issues and correcting based on instructions for the auditors
QUESTIONS
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