Join this webinar which will discuss current, expert, and applicable knowledge about the responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial. The procedures for SAE reporting will be discussed which should be contained in company SOPS and well organized with regard to staff assignments and responsibilities before a trial begins to assure all responsibilities are covered.
Why Should You Attend:
SAE reporting is a critically important function for all clinical trials. It is part of the medical safety responsibilities for a trial and is typical managed by a physician assigned to the clinical trial team.
The primary importance of a clinical trial is to protect the safety of subjects. Secondarily it is to monitor if the product being tested is having any harmful side effects on trial participants.
Clinical trial medical safety is equivalent to pharmacovigilance, but for a single clinical trial. It is a required function for a GCP compliant clinical trial. It is required by US FDA and ICH guidelines.
This webinar will discuss the Definitions for Clinical Safety reporting and processing, development of Clinical Trial Safety Management Plan, Set-up of SAE Tracking System, Record of AE and SAE important variables based on the ICH and FDA guidelines, e.g., causality and severity assessments, SAE reporting and processing; Clinical Site, Sponsor (drug company), and CRO responsibilities.
This webinar instructs on the varied responsibilities and functions among the Drug Company, CRO, and Clinical Site for Medical Safety Management for different types of clinical trials as defined by US FDA and global regulatory guidelines.