The project leader shall submit the application for a multicentre research project to the lead committee in accordance with Article 47 paragraph 2 HRA.
The lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the project leader whether the application documents submitted are formally in order.
At the request of the lead committee, the project leader shall submit the required number of copies of the application documents specified in Annex 2 to the ethics committees responsible at the other research sites (ethics committees concerned). These shall review the local conditions and inform the lead committee of their assessment within 15 days.
The lead committee shall reach a decision within 45 days of acknowledging receipt of the formally correct application. It shall inform the ethics committees concerned of its decision.