A patient received at least one dose of study medication prior to withdrawing from a study. Which analysis population would always include this patient?
What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects?
What is the main focus of 21 CFR Part 11?
An action plan that describes what will be done in a drug study, how it will be conducted, and why each part of the study is necessary is called:
From the Statistical Analysis Plan, patients age is calculated as an integer relative to date randomized divided by 365.25. Given the following annotated CRF:
Which programming code defines the patient's age?