November 10 & 11, 2021
January 19 & 20, 2022
February 23 & 24, 2022
April 6 & 7, 2022
Nov 4 & 5, 2021 - New Orleans, LA
FDA Clinical Trial Requirements, Regulations, Compliance and GCP Virtual Conference: This three-day virtual conference is intended to share information among FDA representatives and the regulated community to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience. The program will focus on the relationships among the FDA and clinical trial staff, investigators and IRBs. The sessions will highlight three areas that present challenges to sponsors and investigational sites: FDA Clinical Research Requirements, Enhancing Success through Communication and Financial Incentives, and Assuring Confidence in Clinical Research.
Clinical research project management is an evolving practice. The purpose of this 4-day workshop is to review project management and risk management principles, budget development / financial management and global considerations for clinical research programs.
This interactive virtual workshop will be facilitated by clinical research professionals with a wealth of industry experience. Through discussion, presentation, and interaction, this program will broaden the participants’ knowledge of the regulatory framework, project management art and science, planning and accounting, and their attitude and aptitude for achieving successful clinical trials.
This virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The three (3) half-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply.
Belonging to SOCRA provides you with the information and resources you need to advance your career and enhance your professionalism.
Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard Abstract: Count Me In...Read More >>
Nancy A. Wintering, LCSW, CCRP Elaine Wang, BS Thomas Jefferson University Abstract: The content of this paper was presented at...Read More >>
Muhammad Waseem, MD, MS, CCRP, CIP, CHSE-A Abstract: While research involving pediatric patients may be challenging, the rewards can be...Read More >>
In order to promote quality clinical research, to protect the welfare of research participants, and improve global health, SOCRA's mission is:
To establish educational programming and provide continuing education for clinical research professionals
To establish an internationally recognized certification program for clinical research professionals (CCRP®)
To foster the professional development and peer recognition of clinical research professionals