New version (09.03.2018): Template for the clinical study agreement. Available in English only.
Attached to the Newsletter you find the template in track-changes mode, highlighting the changes compared to the previous version.
The section “Primary registry” on the screen SNCTP (screen 4, only for clinical trials) has been modified. The modification has been introduce to decrease the number of errors of project registry ID formats (identification number, ID) entered by the applicants:
- It's now mandatory to enter a value for "Name of registry". If it's not yet known, the applicant is asked to select the value "Registry name or number not yet known".
- If a registry name is selected the entry of a corresponding ID is mandatory.
- The ID field now automatically validates the number format for the chosen registry.
All existing correct registry names and IDs are still in submitted projects (there is no action needed for the applicant).
All clinical projects with no entry or that had incorrect entries in "Registry name" and/or IDs have been reset to "Registry name or number not yet known". The applicants must update the info as soon as you they have the correct registry information.
The PDF file has been adapted to reflect the changes on the SNCTP mentioned above. Later, we might add an ‘alert’ to the PDF for the applicant when the “Registry name” and the “project ID number” are missing.
And last, the issue, for some projects, with the empty pages in the PDF has been fixed.
That’s it !