Application for authorisation of a Clinical Trial

We would prefer a copy of all documentation on CD or discett as pdf-files supplied to the one paper version.

• Covering letter with reference to EudraCT number and study title
  
• Application Form signed by sponsor, and in XML on CD/discett
  
• Copy of e-mail with confirmation of the EudraCT number
  
• Protocol, see § 2-2 in the regulation
  
• Patient Information Concent Form in norwegian, see § 4-1 in the regulation
  
• Labelling proposal, see § 5-4 in the regulation
  
• Products without Market Authorisation in Norway; documentation for IMPD
  -Pharmaceutical-chemical documentation also for placebo, see Detailed Guidance 4.1.6.
  -Pre/non clinical documentation
  
• Confirmation of payed fee of 5.000 NOK
  
• Confirmation of signed insurance
  
• Copy of the Application Form directed to the Regional Ethics Committee
  
• Short CV of all participating investigators, dated and signed