Quiz: The scope of the Dutch law (cont’d)

1 Use of an Approved Medicinal Product

A pharmaceutical company wishes to investigate the mechanism, safety, and efficacy of an approved medicinal product in a cohort of 500 patients for whom their doctor has prescribed this medicinal product.

During this 2-year study, the patients will be required to compete a brief questionnaire on five separate occasions; this questionnaire includes questions regarding the patient’s symptoms, use of the medicinal product, and perceived quality of life. The five occasions on which the questionnaire will be completed will coincide with visits to their doctor. Any information collected during the patients’ routine care will also be used for research purposes.

Which of the following applies to this study?

2 Dr. Vonk and Dr. Smit

Two physicians, Dr. Vonk and Dr. Smit, wish to compare efficacy between two different approved medicinal products in both male and female adult patients with rheumatoid arthritis.

Treatment with a specific combination of medicines is preferred by the hospital at which Dr. Smit works; however, Dr. Vonk, who works at a different hospital, prefers using a different combination for treating rheumatoid arthritis. The two doctors plan to compare the data in their patients’ files in order to determine which medicinal product is more effective. No additional tests will be conducted during the study.

Which of the following applies to this study?

3 Obesity

Researchers designed a study to investigate whether insulin tolerability differs between obese adults 18-60 years of age and healthy volunteers. In the study, both glucose and insulin will be administered to the subjects, and blood will be extracted by venipuncture.

Which of the following applies to this study?