Module 4: Clinical and Safety Data Evaluation

The different tests and methods of biostatistics are discussed. The application of different trial designs is simulated, within-trial decisions, data management, extraction, manipulation and storage of data.

Key topics

  • Development of a clinical trial protocol and the investigator drug brochure (IDB)
  • Quality management issues in clinical trials
  • Legal and ethical provisions for protection of clinical trial subjects
  • Statistical methods used in clinical research
  • Collection and evaluation of adverse event data in clinical trials
  • Drug safety monitoring board and other relevant study committees
  • Evaluation and interpretation of clinical trial results

Learning outcomes

At the end of this module the students should be able to describe the:

  1. Development of a clinical trial protocol and the role of the investigator drug brochure (IDB)
  2. Principles and practical relevance of ethical and legal issues in biomedical research
  3. Evaluation and interpretation of clinical trial results
  4. Main statistical methods used in clinical data evaluation
  5. Collection and evaluation of adverse event data in clinical trials