ARCTIC-I

Dear investigator,

Thank you for your interest in the ARCTIC-I Study. Prior recruitment, there are several steps to complete. Once all the steps are final and we are aware of your starting date, we will send you the access for the eCRF in OpenClinica.

NOTE : Principal Investigator must be a qualified doctor and all documents must be signed by the PI.

Mandatory steps before starting recruitment :

1. Be listed on the list of participating Centres
2. Sign the Protocol
3. Complete the pre-study survey (1x per site)
4. Use validated patient docs Translation – if your country is not in there, or you are missing a document, please contact your National Coordinator.
5. Sign the Data Processing/Transfer Agreement : Please contact us to have the specific document required for your country
6. Send names and emails of eCRF users: Max 3 persons with eCRF profiles per hospital. Investigator user profile+ 2 data-entry users (provide first name, last name and email addresses)

*eCRF users will have access to the electronic data capture system but this does not mean they will be included as collaborators in publications. PIs will provide the list of collaborators at the same time as the ‘End of study report’ (i.e. at the end of the site’ recruitment). Please refer to the Publication Policy for details about who are named in the publications.

7.An estimate date that your centre can have the possibility to start the recruitment process

8.Approval docs : Each centre must send 2 things :

1. 1. Approval Coversheet and
   2. Letter of approval/notification receipt from ethics/local authorizing body available

Chief Investigator

Participating Countries