Clinical
eTMF
eTMF
Investigator AccessThe Investigator user role is a user type that allows users to upload documents to placeholders only.
The Investigator user role is idea...
Multi-Document PlaceholdersMulti-Document Placeholders enables users to create multiple files from a single Placeholder. This is used in locations that may require m...
Inspector User RoleKivo allows for virtual inspections using the "Inspector" user account role.
The Inspector user role allows the sponsors to restrict acc...
Redact a PDF documentKivo offers Redaction feature, this allows the user to remove visible text and graphics from a pdf. 1. Log in to Kivo and Navigate to a PD...
Add Unblinded Document from UploadAs part of our eTMF product, Kivo supports adding unblinded documents. Users can be granted the ability to view unblinded documents at a f...
CTIS Builder
CTIS Builder
Export a submission application zip fileIf you wish to export the submission application built in the submission builder, here are the steps:Step 1: Open the submission builder a...
Add the Metadata information about a submission applicationMetadata section in a submission application is a tab where a user can specify all the important metadata information about a submission. ...
Link a document to a section of the submission applicationSubmission structures can be imported and exported in Kivo. Kivo solution already comes with submission structures and templates like IND,...
Add a Redacted PDF to a Submission Log into Kivo and navigate to Submission Builder. Submission Builder is located on the bar on the left side.
Select the Section where yo...
Adding an Unblinded document from a placeholder1. Log in as a user with "Can View Unblinded permission"
2. Navigate to the folder to upload an Unblinded document
3. Click the Blue Plu...
Modify the Name of an ApplicationClick on Submissions
Select a category
Select a…
Renaming a product in Submission BuilderClick on Submissions
Select a category
Select the…
Selecting a specific version of a document in a submissionClick on Submissions
Select a category, product, application and submission
Select a module and section
In the center pane will b...
Export and Download a SubmissionClick on Submissions
Select a Category, Product, Application and Submission
In the Center top will be an “Export” button
Click the ...
Adding a Document to a SubmissionClick on Submissions
Choose a Category, Product, Application and submission.
Select a module and section from the list on the left...
Access the Submission BuilderClick on Submissions.
Select a Category, Product, Application and Submission.
The Submission tree is displayed.