Clock-stop possible if complementary information requested
Yes
National legal framework in place
Yes
Applicable national legal framework/ Reference
Art 33 Law 21/2014 (pt)
Additional Information
Submission to INFARMED and CEIC are simultaneous at RNEC. Submission to Health Units and respective Ethical Committee are done at the same time. A DPO in each Health Unit is responsible for assuring the compliance of data protection procedures with GDPR.
