Title: Good Clinical Practices for the Clinical Research Professional - 4 Part Online Training Series
Date(s) And Time(s): Oct 12 2010 12:00PM - Oct 15 2010 2:00PM
Interest Area(s): Professional Education, Training & Development,Clinical Research,Regulatory Affairs
Overview:
Gain the knowledge required to conduct clinical trials, including knowledge about subject safety, regulations, and the practicalities of performing research studies.
WHAT YOU WILL LEARN
· Roles and responsibilities of each member of the study team
· Regulations and guidelines that govern clinical investigations
· Consent elements and consent process
· Successful patient recruitment and retention strategies
· Importance of study compliance during clinical trials
· Adverse event handling and reporting
· Preparing for audits and audit process
Part 1: Roles and Responsibilities – Tuesday, October 12, 2010 (12:00-2:00 pm)
Part 2: Regulations and Guidelines that Govern Clinical Investigation - Wednesday, October 13, 2010 (12:00-2:00 pm)
Part 3: Practices that Ensure Effective and Efficient Study Conduct - Thursday, October 14, 2010 (12:00-2:00 pm)
Part 4: Practices that Ensure Effective and Efficient Study Conduct (Cont’d) - Friday, October 15, 2010 (12:00-2:00 pm)
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Identify the roles and responsibilities of each member of the study team including the clinical investigator, sub-investigator, study staff, IRB, and sponsor
- Apply the regulations and guidelines for conducting safe and effective clinical trials
- Describe the various processes for informed consent
- Recognize successful patient recruitment and retention strategies
- Manage study compliance during clinical trials
- Properly categorize and report adverse events
- Recognize the multiple types of audits and how to prepare for each
Target Audience: • Clinical investigators • Clinical research professionals • Sub-investigators • Study staff
Event Code: 10479
Contact Information:
For detailed program information including faculty and topics, please contact: Colleen Buckley Tel. +1-215-442-6108 Email Colleen.Buckley@diahome.org
If you have not received confirmation within 5 business days, please contact: DIA Tel. +1-215-442-6100 Fax +1-215-442-6199 Email confirmationservices@diahome.org
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