Event Detail

Good Clinical Practices for the Clinical Research Professional - 4 Part On-line Training Series (Part 1)
July 9 - 23, 2009 - Online Web Seminar PA UNITED STATES

DIA - Drug Information Association

Colleen.Buckley@diahome.org

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 comliance during clinical trials Adverse event handling and reporting Preparing for audits and audit process Part 1: Roles and Responsibilities – Thursday, July 9, 2009 (12:00-2:00 pm) Part 2: Regulations and Guidelines that Govern Clinical Investigation - Thursday, July 16, 2009 (12:00-2:00 pm) Part 3: Practices that Ensure Effective and Efficient Study Conduct - Wednesday, July 22, 2009 (12:00-2:00 pm) Part 4: Practices that Ensure Effective and Efficient Study Conduct (Cont’d) - Thursday, July 23, 2009 (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: 09487

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