Clinical
By Casey1 author18 articles
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...
- Closing an eTMF CabinetPermanently close an eTMF cabinet at study end to lock all documents, remove all folder permissions, and trigger a data integrity report.
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.