AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To obtain 'commonality' in reporting, investigative sites require familiarity with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug.
See Why determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).
Without a doubt or question, accurate collecting and reporting of Adverse Events (AE’s) is really the single most important function of the Investigational team as far as Subject safety is concerned.
Why Should you Attend:
With the increasing complexity of the Investigational Medicinal Products (IMP’s), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.
Objectives of the Presentation:
Who can Benefit:
- The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
- How to know what an Adverse Event is and when to report it or them
- Knowing the AE types and likelihood of finding “rare” events
- Understanding laboratory AEs and the "Reference Range" concept
- Common Mistakes in AE / SAE Reporting
- Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
- How to record Adverse Events and assess causality - the algorithm
This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators
- Sub Investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Safety Nurses
- Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
- QA / QC auditors and staff
- Clinical Research Data managers