Clinical Trial Application and Results related documentation

Clinical Trial Application

• Legislation: Eudralex Vol 10, Chapter 1, Annex I: CTA form
  
  
• Process: Registering a trial and updating its information, Frequently asked questions (see section on protocol information).
  
  
• Instructions for data completion: CTA Pick lists and Coded Values, Data dictionary; Validation rules v.8.2 (31/5/2012) EEA CTA - tabular and XML format, Third country file - tabular and XML format.
  
  
• CTA v7 to v8: How to convert v7 to v8, v8.1 guidance, Tool tips for IE6 users (v8.0), New fields in v8.0 , Country Mapping List, Controlled Terms Mapping List
  
  
• Schemas: EEA CTA, Third country file, XML Schemas v.8.1; Gateway technical specification, acknowledgement message, main message, message header
  

Results

• Legislation: Commission guideline, Joint letter signed by EC, EMA and HMA, Modalities and timing of posting
  
  
• Process: Tutorials on posting results (step 2 documents: primary user request form, guidance for completing, service level agreement), Frequently asked questions (see section on results information).
  
  
• Instructions for data completion: Validation rules to correct errors/warnings, Data dictionary and XML schemas of the full data set.