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).
Learn what the risk information is that must be collected, documented and reported accurately. How to know what is and what is not an adverse event, the common mistakes in AE/SAE reporting. Learn why and how to do get the awareness, do assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. How to record Adverse Events and assess causality - the algorithm.
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
Who Will Benefit:
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) and Coordinators (CRCs).
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
Instructor Profile:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations. He has been in the Clinical Research Industry for 20+ years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.
