Highlighted the desired Study/Country in Selected Studies/Countries window.
Click on ESSENTIAL DOCUMENTS under STUDY/COUTRY level in the
tree displayed and then on edit in the right horizontal
toolbar.If you need additional documents
click on ADD in the right
horizontal toolbar.˘ Some documents can be added multiple times (not unique version) to the Study/Country Essential Documents.
Default list of essential documents displayed varies
depending on national requirements.
Essential documents which are needed at Study/Country level for all studies are listed by default (compulsory). They cannot be removed from the list.
Essential documents that have been defined as 'Not systematic' for Study/Country level can be added manually as required.
If defined as 'not unique' in the administration module, some documents can be added multiple times to the Study/Country Essential Documents.
Except for the following described columns, the other are completely variable and depending of your designed (done in the administration module)
.Essential documents which are needed at Study/Country level for all studies are listed by default (compulsory). They cannot be removed from the list.
Essential documents that have been defined as 'Not systematic' for Study/Country level can be added manually as required.
If defined as 'not unique' in the administration module, some documents can be added multiple times to the Study/Country Essential Documents.
Except for the following described columns, the other are completely variable and depending of your designed (done in the administration module)
Click on ADD in the right horizontal toolbar to get a list of
essential documents that can be
added to the default list for this Study/Country.
Option in Study/Country Essential Documents:
SUBMISSION: to track submission to/approval by Regulatory
Authority for the highlighted document (only document with the
type 'Protocol' or 'Subject to Regulatory Authority'). Only
available if there is one or multiple Regulatory Authority at
the National level (defined at the country level or in the
Study/Country Form).