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Interventional Research > 21. Ethical and legislative aspects of intervention trials > Flashcards

21. Ethical and legislative aspects of intervention trials Flashcards

(e.g., METC-procedures, WMO, GCP, international harmonization, requirements).

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Interventional Research (18 decks)

1. Classes of intervention studies

2. Rationale of and prerequisites for experimental intervention research

3. Historical development of intervention trials

4. Core elements of the ‘classic’ intervention study design

5. Intervention strategies

6. Alternative intervention study designs

7. Random allocation

8. Study population

9. Design/choice of the intervention

10. Outcome measurement

11. Pros and cons of a run-in period (qualification period).

12. Role of placebo intervention within the context of a randomized trial.

13. Pragmatic vs. explanatory designs

14. Mixed methods designs

15. Protocol violations

16. Statistical analysis of intervention trial results

17. Sample size and power calculation

21. Ethical and legislative aspects of intervention trials

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