Which data/documents have to be submitted together with notification of the study?, State Institute for Drug Control

Which data/documents have to be submitted together with notification of the study?

The list of required data and documents submitted (in line with SÚKL on-line form):

Name/business name and address of the marketing authorization holder
Identification of the study product, a code that is assigned to the product by SÚKL
Title of the study (and ID number of study assigned by MAH)
Date of start of data collection, expected date of end of data collection, expected date of data analysis end and expected date of the final report submission
Study protocol submission via online form

+420 272 185 111
phone book

cs_CZ

en_GB

2010 © SÚKL. Šrobárova 48, 100 41 Praha 10, +420 272 185 111, posta@suklcz.

Web portal supplier - QCM, s.r.o.