Reporting Adverse Events What, When, How?. Cynthia Gross Professor, College of Pharmacy and School of Nursing The MN Center for Health Trajectory Research Presentation 12/3/09. Learning Objectives.
Describe systems for coding events
Outline UMN IRB reporting procedures
List key resources
(definition modified from on the 1996 ICH E-6 Guidelines for Good Clinical Practice).
Less clearly defined
Determination of Problem may not be clear-cut
Determination of relatedness rests with the study investigators and their monitors (site investigator, independent monitor, overall protocol PI, Data Safety Committee, etc.)
What is related may not be immediately apparent
or may remain uncertain
from NCI, CTEP guidelines
Most AEs are not unanticipated problems; not all problems are AEs.
• An open-source software tool that is used to collect, process, and report AEs
• Tool supports regulatory compliance and allows local collection, management, and querying of routine and expedited AEs (UPIRTSOs)
Investigators have the primary responsibility for AE identification, documentation, evaluation/grading and assignment of attribution.
Investigators have to report to their IRB, sponsors and others.
MedDRA and CaAERS assist by providing common terminology and classification systems, but the determination of severity, attribution (relatedness) require the direct involvement and judgment of the investigators – ultimately the study principal investigator.
Main Resources used in this talk:Reporting Unanticipated Problems, Institutional Review Board (IRB), University of Minnesota http://cflegacy.research.umn.edu/irb/ae/UPIRTSO Reporting Policy, Office for Human Research Protection, Mayo Clinic http://mayoresearch.mayo.edu/mayo/research/irb/upirtso_reporting_policy.cfm Guidance Document: Office for Human Research Protections (OHRP) Department of Health and Human Services (DHHS)http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm