Documentation required by ethics committee in order to evaluate a not-for-profit study
| Country | National approval | Local approval | Competent authorities approval | Insurance | GCP monitoring | Drug supply | EudraCT | Financial agreement | Ethics committee fees |
|---|---|---|---|---|---|---|---|---|---|
| Austria | X | ||||||||
| Belgium | X | X | X | X | |||||
| Bulgaria | X | X | X | X | – | – | – | – | |
| Croatia | X | X | X | X | |||||
| Czech Republic | X | ||||||||
| Denmark | X | X | X | ||||||
| Finland | X | X | X | ||||||
| France | X | X | X | X | X | ||||
| Germany | X | X | X | ||||||
| Greece | X | ||||||||
| Hungary | X | X | X | ||||||
| Italy | X | X | X | X | |||||
| Latvia | X | ||||||||
| Netherlands | X | X | X | X | |||||
| Norway | X | X | X | ||||||
| Poland | X | ||||||||
| Romania | X | ||||||||
| Slovakia | X | ||||||||
| Slovenia | X | ||||||||
| Spain | X | X | X | ||||||
| Sweden | X | X | |||||||
| UK | X | X | X | X | X | X | X | ||
| Non-EU countries | |||||||||
| Argentina | X | ||||||||
| Australia | X | ||||||||
| Brazil | X | X | |||||||
| Georgia | X | ||||||||
| Israel | X | ||||||||
| Mexico | X | X | |||||||
| Serbia | X | ||||||||
| Switzerland | X | X | X | ||||||
| Turkey | X | X | X | X | |||||
| USA | X | X |
This table is based on the experienced gained by the Paediatric Rheumatology International Trials Organisation in an academic clinical in children with juvenile dermatomyositis and does not claim to be exhaustive.
GCP, good clinical practice.