Rules and regulation

11 important questions on Rules and regulation

Name one example of a not WMO research

- doing handgrip, waist measurement, short questionnaire.

Name one example of a research that falls under WMO law.

Doing blood samples, long questionnaires, personal questions, new medication

Why is it important to determine if your research falls under the act of WMO or not?

If it falls under WMO, the review procedure would be more or less strict
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When would you have to describe Serious Adverse Effects (SAE)?

When your research falls under the WMO act. If it doesnt, you dont have to describe the SAE.

What is the goal of a kickoff in a study?

To know the tasks and responsebilities of all the people involved.

What are Case Report Forms (CRP)?

An electronic paper document in a clinical trial to record protocol and required information about each participant.

What does a monitoring board do in a study?

During the time the study is running, the monitoring board will check the process. The goal is guarding safety of patients and ensuring quality of the research

Name 5 things the monitoring board will be checking

- informed consent
- in and exclusion criteria
- source data verification
- protocol violations
- check serious adverse effects

What is 'Good Clinical Practice' (GCP)?

An international ethical and scientific quality standard for designing, recording and reporting trials that involve human subjects

What is the Declaration of helsinki?

A declaration by the World Medical Association (WMA) that protects humans.
it protects ethical principles, personal information and safety procedures.

Why does research have to be monitored?

Because in the past there has been unethical research. Also there has been made up data to ensure the outcomes were significant.

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