The more experienced members spar and help the newest members, and although we take our training seriously, we make sure that you have a ton of fun while you get in the best shape of your life.
The 2018 conference will offer workshops on the following topics: This workshop will address Food and Drug Administration (FDA) perspectives and the regulations regarding adherence to protocol, records management, patient rights, drug / product management and record keeping, and regulatory issues related to an FDA audit.
This workshop will discuss fundamental concepts and current issues in the development and implementation of an effective Standard Operating Procedure (SOP) program for clinical sites.
Basic principles, as well as challenges, will be introduced through lecture, discussion and “hands-on” exercises.
In an effort to enhance quality assurance at academic institutions, private practices or government-supported sites, SOCRA is offering a workshop for research personnel who are new to the field, or for those coordinators who want to refresh their understanding of GCP in the ever changing world of clinical research.
This four-hour interactive workshop will include presentations, group discussion, and Q&A.
This interactive workshop will provide the following: A brief introduction to the FDA; Overview of clinical research, including the Federal Regulations covering clinical research and clinical investigator obligations; Discussion on Trial Site Roles and Responsibilities; Explanation of the FDA’s Bioresearch Monitoring Program, focusing on the Clinical Investigator inspection; Insight on understanding the FDA GCP inspection: Who is the FDA auditor? Common FDA inspection findings at the clinical site audit; Specific examples of FDA-483 observations; FDA inspection strategy. This workshop will discuss the regulatory obligations of an IND/IDE sponsor-investigator. Arbit will describe the resources needed to support and the risks associated with conducting investigator-initiated clinical trials.
Process standardization is also important to ensure that clinical trials are run in the most efficient way possible with as much consistency used across similar studies as possible.
The annual conference offers 14 Preconference workshops for those looking for in-depth education.
This workshop will educate the attendee in Good Clinical Practice (GCP) requirements and FDA audit expectations, in order to aid in preparation for an FDA GCP audit.
Critical information will be presented and discussed including investigational site best business practices, the necessity for SOPs, SOP development, prioritizing SOPs, and implementing SOPs at the investigational site.
Techniques for writing effective SOPs will be discussed and participants will develop a relevant investigational site SOP.