Program Description

Advanced Concepts for Clinical Investigators and Key Research Staff: GCP & Clinical Trials Management Conference 

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist Clinical Investigators and key research staff in improving their skills and their understanding of the responsibilities of the clinical research site. This program is intended to share information and create opportunity for dialogue among clinical investigators, key research staff and program faculty. The specific goal is to enhance the participants’ ability to perform quality clinical research according to existing regulations and guidelines. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).

Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council for Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.

Learning Objectives: Upon completion of this course the attendee should be able to:

  • Describe the drug development process
  • Discuss investigator and investigational site responsibilities related to regulations and ethics
  • Describe the protocol development process
  • Describe the research grant proposal development process
  • Discuss the informed consent process
  • Explain development of informed consent forms: Rights, Rites, and Rewrites
  • Describe investigator-initiated research projects
  • Discuss safety reporting and adverse events / serious adverse events
  • Explain source documentation and research record management
  • Discuss the financial management of study funds
  • Discuss the elements related to successful clinical study agreements
  • Describe the basic requirements of monitoring visits and audits
  • Discuss the development and implementation of standard operating procedures