SSStudyParticipantsVulnerablePopulation object
Considered as vulnerable population
Children
Elderly
Pregnant women (Pregnancy)
Unconscious Persons
Incapacitated adults
People with psychiatric disorder
People with dementia
Prisoners
Vulnerable population - Additional information
It depends on the mental status if or if not elderly are considered as vulnerable population.
it is not validated if of if not lactating women are considered as vulnerable population
Regulations concerning the inclusion or exclusion available
Yes
Regulations concerning the inclusion or exclusion
federal states monitor inclusion or exclusion of vulnerable groups.
Applicable ethical regulations
Institutional
National
International
EU directive (2001/20/EC)
Not validated
Additional Information
AMG – Arzneimittelgesetz apply for pharmaceuticals/drug trials
