Regulatory Affair Clinical Trials

Exam Questions 1. Identify and describe 3 different means to evaluate on-site study conduct. Include the responsible party and driver of each means. How are these means complicated by including both domestic and foreign trial sites, if at all? Be thorough and specific while keeping content and length in mind. 2. List and describe 2 different challenges associated with a clinical trial that enrolls from both domestic and foreign trial sites. Complete response will include the mean or solution to resolve each of these challenges. Be thorough and specific while keeping content and length in mind. 3. Explain the purpose of clinical trial registration and submission of trial results from perspective of global trial (both domestic and foreign trial sites). In addition, list the parties (stakeholders) that benefit and provide explanation as to why this would be considered a benefit. Be thorough and specific while keeping content and length in mind. 4. What is the current FDA position for including international clinical data in a New Drug Application (NDA)? Be thorough and specific while keeping content and length in mind.

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