• Roles and responsibilities of each member of the study team
• Regulations and guidelines that govern clinical investigations
• Informed consent elements and processes
• Successful patient recruitment and retention strategies
• Adverse event handling and reporting

• Clinical investigators
• Clinical research professionals
• Sub-investigators
• Study staff

At the conclusion of this activity, 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
• Describe the requirements in reporting adverse events