Program Objective:

• Describe the drug development process, the importance of Good Clinical Practice, and the roles and responsibilities of the research team
• Define the regulatory requirements, explain the differences between ICH and FDA guidelines, and describe the elements of a protocol
• Outline required elements of the informed consent
• Identify the investigational product accountability requirements and impact of the reconciliation process on the study
• Define the safety definitions and comprehend the safety reporting requirements
• Prepare for and complete source document verification
• Perform the steps involved in monitoring the study pre-visit, during the visit, and post-visit
• Create cohesive, well-written protocol deviations and action items, and accurately complete the monitor visit report and site follow-up letter
• Define the impact of quality assurance and audits in clinical research

Program outline:

• Module 1: Drug Development Process, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
• Module 2: IRB, Clinical Study Protocol Elements and Amendments
• Module 3: Informed Consent
• Module 4: Investigational Product Accountability
• Module 5: Safety Definitions and Reporting Requirements
• Module 6: Source Document Verification
• Module 7: Monitoring the Study
• Module 8 and Module 9: Monitoring Visit Reports and Contact Reports
• Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections

Who can attend :

• Clinical Research Associates with less than two years of experience – in-house or field-based
• Those currently working in the industry in a different role and seeking to change roles
• The course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required)

NOTE: This course is for individual registrants only and does not allow for group training.