CRA training program

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 the 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 monitoring visit report and site follow-up letter

Define the impact of quality assurance and audits in clinical research