Clinical Site Coordinator / Manager and GCP Workshop: GCP for Coordinators, Research Associates, Study Nurses, and Site Managers (Apr, 2018)
In-Person Event
Apr 12 - 13, 2018
Toronto, Ontario, CASpeakers
OVERVIEW
Clinical Site Coordinator / Manager and GCP Workshop: GCP for Coordinators, Research Associates, Study Nurses, and Site Managers is organized by Society of Clinical Research Associates (SOCRA), Inc. and will be held during Apr 12 - 13, 2018 at Radisson Admiral Hotel Toronto-Harbourfront, Toronto, Ontario, Canada. This CME Conference has been approved with a maximum of 14.00 AMA PRA Category 1 Credits.
Conference Description :
The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. 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 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 with a combined industry experience of more than 20 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Conference Objectives are :
• Discuss aspects of clinical trials that are governed by regulations and guidelines.
• Discuss the basic philosophy and guiding principles of clinical research GCP.
• Discuss the elements of the Informed Consent Form, the ethical principles originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
• Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
• Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
• Discuss the rationale and issues surrounding the monitoring visit and the audit process from a site, a sponsor, and a regulatory perspective.
• Discuss the parameters, goals, and outcomes of audits and inspections.
• Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.
Additional details will be posted as soon as they are available.
Conference Description :
The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. 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 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 with a combined industry experience of more than 20 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Conference Objectives are :
• Discuss aspects of clinical trials that are governed by regulations and guidelines.
• Discuss the basic philosophy and guiding principles of clinical research GCP.
• Discuss the elements of the Informed Consent Form, the ethical principles originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
• Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
• Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
• Discuss the rationale and issues surrounding the monitoring visit and the audit process from a site, a sponsor, and a regulatory perspective.
• Discuss the parameters, goals, and outcomes of audits and inspections.
• Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.
Additional details will be posted as soon as they are available.
KEY DATES
12 Apr, 2018
Event Start Date
13 Apr, 2018
Event End Date
SPECIALITIES
Research and Clinical ResearchSUGGESTED HOTELS
CONFERENCE VENUE
Radisson Admiral Hotel Toronto-HarbourfrontRELATED CONFERENCES & LIVE WEBINARS
Quick Links