20181212_Data Integrity and Compliance_Yuan愿 Song宋
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The document outlines the role of data integrity in current good manufacturing practice (CGMP) for drugs, as presented by Professor Yuan Song from Duke University. It discusses the FDA's clinical trial inspection program, the targets of inspections, and post-inspection activities, emphasizing the importance of managing data integrity and compliance. Inspections impact review and approval processes, potentially delaying approvals and necessitating additional audits and studies.
20181212_Data Integrity and Compliance_Yuan愿 Song宋
- 1. Data Integrity and Compliance Yuan Song Professor, Data Scientist Duke University 1Copyright by Bigfish HealthDec.12, 2018
- 2. DISCLAIMER The views and opinions presented represent those of the speaker and should not be considered to represent advice or guidance on behalf of the Food and Drug Administration. Dec.12, 2018 Copyright by Bigfish Health 2
- 3. • Published in the Federal Register on December 13, 2018. • Clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. • Firms should implement meaningful and effective strategies to manage their data integrity. Dec.12, 2018 Copyright by Bigfish Health 3
- 4. FDA’s Clinical Trial Inspection Program •Human research subjects protection •Data integrity and reliability •Regulatory compliance 4Copyright by Bigfish HealthDec.12, 2018
- 5. GCP Inspections for Clinical Trials Applicant submits NDA/BLA Site Selection Inspection Assignment Inspection Recommendation Approval Decision Dec.12, 2018 Copyright by Bigfish Health 5
- 6. Inspection Targets •Clinical Investigator (CI) •Sponsor/Monitor (S/M) •Contract Research Organization (CRO) •Institutional Review Board (IRB) Dec.12, 2018 Copyright by Bigfish Health 6
- 7. FDA Inspection of Clinical Investigator Sites • Source data verification • Assess CI’s • Qualifications and oversight of study • Knowledge of the protocol • Adherence to study protocol • Recordkeeping • Test article accountability • Evaluate informed consent/IRB approval • Communications with monitors/sponsors • AE reporting Dec.12, 2018 Copyright by Bigfish Health 7
- 8. FDA Inspection of Sponsor/CRO Sites • Review sponsor's Roles/responsibilities • Oversight of the target study • Handling of study data • Handling/accountability of investigational product • Adverse event reporting • Study monitoring, relevant communications (with investigators, with • CROs) • Recordkeeping and record retention Dec.12, 2018 Copyright by Bigfish Health 8
- 9. Post-Inspectional Activity • Review and evaluate inspectional observations, evidence provided in inspectional report • Provide recommendations to CDER review divisions regarding data reliability and integrity in clinical inspection summaries (CIS) • Issue post-inspectional correspondence to inspected entity Dec.12, 2018 Copyright by Bigfish Health 9
- 10. Impact of Inspectional Findings Impact on Review •Additional Inspections •CIs, sponsors/monitors, CROs •Third Party Audits •New Studies Impact on Approval • Approval may be delayed for further inspections and analyses • Post-marketing studies may be required Dec.12, 2018 Copyright by Bigfish Health 10
- 11. Copyright by Bigfish Health 11 Thank you Q&A Dec.12, 2018