Clinical Investigator GCP & Trials Management Program
December 5 and 6, 2013
Marriott Tampa Waterside
Hotel: 813 221 4900
SoCRA’s hotel room rate of $159 S/D USD (plus applicable taxes) is available until November 1, 2013, or until the SoCRA room block is filled.
Member Fee- $625
Non-Member Fee*- $700
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 13.2 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 13.2 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09
SoCRA Course Series: 400
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 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).
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 Conference on 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:
*SoCRA REGISTRATION POLICIES/INFORMATION:
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