Clinical Site Coordinator / Manager and GCP Workshop (Jul, 2017)
In-Person Event
Jul 13 - 14, 2017
Weehawken, New Jersey, USASpeakers
OVERVIEW
Clinical Site Coordinator / Manager and GCP Workshop is organized by Society of Clinical Research Associates (SOCRA) and would be held during Jul 13 - 14, 2017 at Sheraton Lincoln Harbor Hotel, Weehawken, New Jersey, United States of America. This CME conference has been approved with 14 AMA PRA Category 1 Credit(s).
Objective: 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 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:
• 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.
Objective: 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 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:
• 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.
KEY DATES
13 Jul, 2017
Event Start Date
14 Jul, 2017
Event End Date
SPECIALITIES
Research and Clinical ResearchSUGGESTED HOTELS
CONFERENCE VENUE
Sheraton Lincoln Harbor HotelRELATED CONFERENCES & LIVE WEBINARS
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