Application for authorisation of a Clinical Trial

We would prefer that all documentation is submitted electronically on a CD/USB-stick or by e-mail to post<>noma.no along with a short description of the submission. From October 2008 we do no longer require paper copies of the documentation.

1. Covering letter with reference to EudraCT number and study title
   
2. Application Form signed by sponsor (scanned), and in XML
   
3. Copy of e-mail with confirmation of the EudraCT number
   
4. Protocol, see § 1-5 q) in the regulation
   
5. Mandatory Patient Information Concent Form in norwegian
   
6. Labelling proposal
   
7. Products without Market Authorisation in Norway; documentation for IMPD (4.1.6):
   -Pharmaceutical-chemical documentation also for placebo
   -Pre/non clinical documentation
   -Investigators Brochure
   
8. Confirmation of signed insurance
   
9. Paedriatric Committees Final Summary Report for Paedriatric Invstigational Plan (PDCO FSR for PIP) when this is available
   
10. Copy of the Application Form directed to the Regional Committees for Medicial and Health Research Ethics (REK)
11. Short CV of all participating investigators, dated and signed

Sist gjennomgått: 12.02.2010
Første gang publisert: 21.07.2006