Clinical Trial Management I (E05Z6A)

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Algemeen

  • To apply legislation in regard to clinical studies to specific situations.
  • To draft a contract for the conduct of clinical study
  • To design a clinical trial and to translate trial design into practical trial conduct (interpretation flowcharts, use of Case Report Form (eCRF), conduct of a monocentric clinical trial, understanding the logistic challenges of a multicentric trial). Concrete stepwise inititiation of a clinical trial.
  • To apply Good Clinical Practice (GCP) in concrete situations (students will be GCP certified).
  • Understanding the regulatory agencies (EMA, FDA, FAMHP)
  • To monitor clinical trials
  • To assess and monitor risk
  • To identify strategies for recruitment, retention and follow up of clinical trials
  • Statistics in clinical trials


Examenvorm

Type : Partial or continuous assessment with (final) exam during the examination period Description of evaluation : Written, Paper/Project

Type of questions : Multiple choice, Open questions

Learning material : None

The exam consists of two parts:

  • Multiple Choice with correction for guessing
  • To develop a case study

Distribution of points: 14/20 MC 6/20 case study

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Examenvragen

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