This course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as regulatory requirements. The course consists of lecture and exercises. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent forms for completeness and compliance; conducting drug accountability; reviewing case report forms for accuracy and adherence to protocol and performing source document verification.
You will learn:
- How drugs are discovered and developed for marketing approval
- The history of the FDA and its role and responsibilities
- Medical terminology and abbreviations
- The four different study phases of clinical research
- The principles of ICH GCP (Good Clinical Practices)
- The different types of study monitoring visits and tasks for each visit
- Adverse Events - the types and reporting requirements
- How to perform Drug Accountability and compliance
- How to detect and deal with fraud
- How to review Case Report Forms and determine adherence to protocol
Pre-Requisites: Basic PC Skills. Good oral and written English skills.