Requirements of Serious Adverse Event (SAE) Reporting for Clinical Trials

Why Should You Attend:

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.

The procedures for SAE reporting 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.

Areas Covered in the Webinar:

• SAE reporting requirements
• SAE tracking system
• Narrative writing
• AE and SAE reporting and processing procedures
• The following information will be discussed: regulatory Definitions for Clinical Safety reporting and processing, development of Clinical Trials Safety Management Plans, Set-up of SAE Tracking Systems (based on both paper-based and EDC-based case report forms), 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 Sites responsibilities, Sponsor (Pharmaceutical/Biotech companies responsibilities) and designated CRO responsibilities).
• Narrative writing, MedWatch report and Dear Dr Letter Development
• The following information will be discussed: the minimum data information required to be included in the Subject Narratives based on the TCH and FDA guidelines, brief discussion about MedWatch report generation using SAE Tracking System and the content of Dear Dr Letters. Both MedWatch reports and Dear Dr Letter are required to be created for Expedited SAE reporting and the definition of Expedited SAE reporting will be discussed during this webinar.

Who Will Benefit:

This webinar provide valuable assistance to personnel in biotech, pharmaceutical, and medical device companies. Employees who will significantly benefit by attending this training include:

• Clinical Researchers
• Clinical Product Development Consultants
• Medical Safety Officer
• CMO
• Medical Affairs
• Clinical Trial Project Management

Shide Badri
Vice President, Amarex Clinical Research, LLC

Dr. Shide Badri, VP of Safety and Pharmacovigilance, Amarex Clinical Research - has more than 15 years of experience in medical practice and clinical research. Dr. Badri leads global drug and device safety activities of the Safety and Pharmacovigilance (PV) division, including collecting and evaluating of serious adverse events and adverse reactions, supervises the activities and development of Safety personnel, directs the identification and assessment of potential safety signals, oversees the analysis of clinical data and ensures organizational, financial and strategic goals are attained with respect to Clinical Safety and PV and Risk Management activities.

During her career, Dr. Badri has managed Clinical Safety, Pharmacovigilance, Coding and Medical Monitoring projects, and been involved in writing clinical protocols, clinical study reports (CSRs), annual and period safety reports and Case Report Forms (CFRs) for clinical trials across a broad range of therapeutic indications including Cardiovascular, Dermatology, Endocrinology, Gastroenterology, Hematology, Infectious Disease (Sepsis and Septic shock), Nephrology, Neurology, Oncology, Ophthalmology, Pediatrics, Psychiatry, Pulmonology, Urology, Gene Therapy, Pain Management, Critical Care Medicine, Wound Healing (e.g. Diabetic Foot Ulcers and Venous Leg Ulcers), Vaccines, and Rare Diseases.

Dr. Badri earned her MD degree in 2002 and before joining Amarex worked as a physician in rural and urban health centers with a focused on preventative.

Background:

Serious Adverse Event (SAE) reporting is a critically important function for all clinical trials. It is part of the medical safety responsibilities for a trial. The primary importance is to protect the safety of subjects in a trial. 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.

SAE reporting is typical managed by a physician assigned to the clinical trial team.

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