ICH Gap Analysis
ICH Gap Analysis
Designed in a game-like format using 5 ICH categories (listed below), 12 questions per category are presented in multiple choice and true/false format. A score of at least 75% is required in order to advance to each category. A score below 75% results in the option to begin that category again until a passing score is achieved.
- ICH E2A - CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
- ICH E6(R2) - INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE
- E8 - GENERAL CONSIDERATIONS FOR CLINICAL TRIALS
- E9 - STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
- E11 - CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
Activities Included:
ICH Gap Analysis
Evaluation