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