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Developed by:
U-MIC

2. Post-Approval study Monitoring
Understanding the Investigator’s Role
Part One

3. Responsibilities After Approval
Ongoing PI responsibilities
to ensure compliance with human subjects protections standards
may be performed by the investigator him or herself
or delegated to qualified individuals
Monitor the conduct and progress of the research study

4. What Is Monitoring?
“Quality control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected.” (FDA 2013)
Designed to protect the safety of individual participants in research studies
Intended to ensure the validity of research results and scientific integrity of a study
Helps to ensure risks to subjects are minimized

5. When Is It Needed? IRB approval criteria
Common Rule (45 CFR 46 subpart A)
FDA regulations (21 CFR 56)
“When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”

6. When Is It Needed?
Federal agencies may have monitoring requirements for studies they fund
National Institutes of Health (NIH) Policy for Data and Safety Monitoring
NIH-funded clinical trials undergo data and safety monitoring
Agency for Healthcare Research and Quality (AHRQ)
Data and Safety Monitoring Plan for research that “stud[ies] the effect of a health-related intervention on outcomes in human subjects where there is greater than minimal risk”
Department of Defense
research monitor required for more than minimal risk research
medical or non-medical, depending on nature of research

7. When Is It Needed? FDA regulations
drugs and biologics (21 CFR 312)
devices (21 CFR 812)
require monitoring of conduct/progress of clinical investigations
to ensure
adequate protection of the rights, welfare, and safety of human subjects
quality of the clinical trial data submitted to FDA
University of Michigan Comprehensive Cancer Center (UMCCC) clinical trials
must include data and safety monitoring provisions

8. What Does Monitoring Look Like?
Commensurate with risks
Per NIH Policy, appropriate monitoring “exist[s] on a continuum from monitoring by the principal investigator or NIH program staff in a small phase I study to the establishment of an independent data and safety monitoring board for a large phase III clinical trial.”

9. What Does Monitoring Look Like?
May include:
Communication with research team members
Review of study processes, procedures, and records
Verification of accuracy of data for each enrolled subject
Identification of missing data, inconsistent data, outliers, or any potential protocol deviations that suggest systematic errors in data collection or reporting
Statistical analysis to identify data trends

10. What Might Be Looked At? Is the protocol being followed?
Are records accurate, current, legible, and complete?
Are facilities and resources still sufficient for the study?
Are reports of unanticipated problems or potential noncompliance being shared with the IRB and sponsor?
Has appropriate training been provided to the study team?
Are missing visits or examinations noted?
Has informed consent been documented as required?
Is the delegation of responsibilities appropriate?

11. Post-approval monitoring
end of part one

12. Thank you. Avery Avrakotos Kate Sasamoto Sana Khoury-Shakour The Office of Research Compliance Review Lark Speyer Judy Birk IRBMED