Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors (Jun 28 - 29, 2018)
In-Person Event
Jun 28 - 29, 2018
San Francisco, California, USASpeakers
OVERVIEW
Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors is organized by Society of Clinical Research Associates (SOCRA) and will be held during Jun 28 - 29, 2018 at Holiday Inn Golden Gateway, San Francisco, California, United States of America. This CME Conference has been approved with a maximum of 15.00 AMA PRA Category 1 Credits.
The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.
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 monitoring clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Conference Objectives are :
• Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
• Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
• Explain the drug/biologic development process
• Describe the device development process
• Outline concepts for Good Clinical Practice (GCP)
• Explain the elements of informed consent
• Describe the membership and reporting requirements of IRBs
• Explain rules relating to financial
• Discuss the basics of study design
• Explain the rules and reporting requirements for adverse events and serious adverse events
• Explain study closure procedures and record retention guidelines
• Outline the reasons for monitoring, audits and site visits
• Explain the Food and Drug Administration rules, regulations, and guidelines on research
• Discuss the importance of investigational drug accountability
• Demonstrate and describe how to read clinical reports and records
• Discuss Quality Assurance including, Monitoring and Auditing
• Explain issues that would constitute clinical fraud
The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.
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 monitoring clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Conference Objectives are :
• Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
• Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
• Explain the drug/biologic development process
• Describe the device development process
• Outline concepts for Good Clinical Practice (GCP)
• Explain the elements of informed consent
• Describe the membership and reporting requirements of IRBs
• Explain rules relating to financial
• Discuss the basics of study design
• Explain the rules and reporting requirements for adverse events and serious adverse events
• Explain study closure procedures and record retention guidelines
• Outline the reasons for monitoring, audits and site visits
• Explain the Food and Drug Administration rules, regulations, and guidelines on research
• Discuss the importance of investigational drug accountability
• Demonstrate and describe how to read clinical reports and records
• Discuss Quality Assurance including, Monitoring and Auditing
• Explain issues that would constitute clinical fraud
KEY DATES
28 Jun, 2018
Event Start Date
29 Jun, 2018
Event End Date
SPECIALITIES
Research and Clinical ResearchSUGGESTED HOTELS
CONFERENCE VENUE
Holiday Inn Golden GatewayRELATED CONFERENCES & LIVE WEBINARS
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