Highlighted the desired study in Selected Studies window.
Click on ESSENTIAL DOCUMENTS under STUDY level in the tree
displayed and then on edit in the right toolbar.If you need additional documents
click on ADD in the right
toolbar.Some documents (not unique version) can be added multiple times to the Study Essential Documents.
Essential documents to have in TMF and in Investigator's
on-site file are defined in ICH-GCP and in your internal
SOPs.
All essential documents which are needed at study level for all studies should be listed by default (compulsory). If they are compulsory, they cannot be removed from the list.
Essential documents that have been defined as 'Not systematic', i.e., are not needed for all studies on study level, (such as Amendment) can be added manually as required.
Some documents can be added to the Study Essential Documents as many times as needed (not unique version).
Except for the following described columns, the others are completely variable and depending of your design (done in the administration module).
All essential documents which are needed at study level for all studies should be listed by default (compulsory). If they are compulsory, they cannot be removed from the list.
Essential documents that have been defined as 'Not systematic', i.e., are not needed for all studies on study level, (such as Amendment) can be added manually as required.
Some documents can be added to the Study Essential Documents as many times as needed (not unique version).
Except for the following described columns, the others are completely variable and depending of your design (done in the administration module).
Add Essential Documents
