In this Clinical compliance training learn how to assess record and manage the adverse events occurring during conduct of clinical research utilizing human subjects and how to avoid the common mistakes.
Why Should You Attend: 
The principal objective in a new drug development program is to assess the benefit / risk ratio. 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. Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).
 
Areas Covered in the Seminar:

• The CFR 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.
• 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
• The Role of Data safety Monitoring in Protecting Human Volunteers
• How to record Adverse Events and assess causality - the algorithm