WorksheetsLegislation and regulation in research
Total questions: 9
Worksheet time: 5mins
What does AVG (i.e. GDPR) stand for?
Algemene Verordening Gegevensbescherming
Algemene Verordening Gemeentebelastingen
Aardappels Vlees Groente
Alles Verandert Gigantisch
The ICH GCP E6(R2) Guideline applies to all interventional research
True
False
What are the two most important basic principles of the ICH GCP E6(R2) Guideline?
Rights, safety and well-being of the research subjects
Data integrity
Compliance legislations and regulations
Permission to start the research from an independent IRB
Which one is correct, with regards to legislation and regulation of medical devices ?
Harmonised in EU, differences in implementation
Regulated individually for each country
Coordinated globally
Only harmonised in the USA
Which laws are applicable to research into the psychiatric past of ICU patients using data from EPIC?
WGBO
AVG
WMO
None of these
A research subject is suffering from an adverse reaction to a new medicinal product. Can you advise the subject to stop?
Yes
No
Non-therapeutic interventional research regarding minors should be evaluated by the local IRB
Yes
No
Therapeutic interventional research with minors should be evaluated by the local IRB
Yes
No
Which of the following laws are applicable to randomised clinical research with new forms of radiotherapy?
WGBO
WMO
AVG
None
