Clinical Research Professional Certification Preparation and GCP Review Course (Jan 18, 2018)
Speakers
OVERVIEW
Clinical Research Professional Certification Preparation and GCP Review Course is organized by Society of Clinical Research Associates (SOCRA) and will be held on Jan 18, 2018 at University of Kansas School of Medicine, Kansas City, Kansas, United States of America. This CME Conference has been approved for a maximum of 6.50 AMA PRA Category 1 Credits.
Conference Objective :
The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records.
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 disclosure
• 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
Additional details will be posted as soon as they are available.
Conference Objective :
The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records.
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 disclosure
• 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
Additional details will be posted as soon as they are available.
KEY DATES
18 Jan, 2018
Event Start Date
18 Jan, 2018
Event End Date
SPECIALITIES
Research and Clinical ResearchSUGGESTED HOTELS
CONFERENCE VENUE
University of Kansas School of MedicineRELATED CONFERENCES & LIVE WEBINARS
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