Clinical Investigator GCP and Trials Management Program for Clinical Investigators and Key Research Staff 2015

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 intent of which 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 Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).

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 Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.