Submission structures can be imported and exported in Kivo. Kivo solution already comes with submission structures and templates like IND, NDA, 1571 etc. There is option to re-use the existing templates or additional custom cabinet structures can be uploaded as well.
User with editor permissions can link/ unlink document to a submission application.
Documents can be easily searched and associated with an application or a submission in Kivo. Below are steps to search and link a document from the Document Management System to an application.
Step 1: Open the submission builder, and from the list of various submission sequence, open the sequence to which you wish to link a document.
Step 2: The sections and folder structure will open up. Click on the section to which you wish to link the document from document management system.
Step 3: Now the option to drop the file under a selected section will be visible along with the a section where files can be search.
Step 4: All the available documents in the document management system are searchable. A user can either search by typing the document name in the search bar or, by searching for the file within various folders or by searching pinned documents.
Step 5: The user can drag and drop the document they wish to link to a section of the submission application. By default, the latest PDF version will be linked to the section, incase more than one versions of the document available. However, the user will have the ability to look for additional versions of a document and choose a specific version and file type they wish to link.
Note: The Output file name of the uploaded document are ICH compliant, we remove extra characters spaces but if the user want to edit the output file name, they can edit the name, and the output will have the updated file name. And each file name must be unique.
Step 6: Attached file can be removed as well.
Please note that prior to linking the document can be previewed as well, click on the word, pdf icons.