Table 1.

Europe: example of documents required for a clinical trial application

Clinical Trial Application required documents
EudraCT number
IB
IMPD
IND application (in the United States) if available
Information of investigators, recruiting sites, and analysis laboratories
Details of drug manufacturing and distribution
Trial production and sample consent form
Completed application form
Information from independent ethics committee
Fee

NOTE: From the Medicines and Healthcare products Regulatory Agency (9).