CASubmissionFormat object
Format option(s)
One copy of each document (A4) in a ring binder (colour indicated on Swissmedic homepage) + one electronic copy on a CD-ROM.
Standard application form
“Clinical Trial Application Form (CTA Form)” for clinical trials with IMP and ATMP (transplant products, gene therapy products, genetically modified organisms/GMO)
Standard application form - Additional information
The required documentation described in the Clinical Trial Application Dossier Guideline must be accompanied by the completed and signed Standard application form.
This standard form is available in ‘Forms and Checklists’ on the Swissmedic website in section: Home > Licensing > Clinical trials Clinical trials on medicinal products > Clinical Trial Application.
Use of standard application form binding
Yes
