The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. This presentation was developed by Yuan Song to facilitate trainings for data integrity and compliance for clinical trial inspection.

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
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6. Inspection Targets
•Clinical Investigator (CI)
•Sponsor/Monitor (S/M)
•Contract Research Organization (CRO)
•Institutional Review Board (IRB)
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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
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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