Version 2 of Kivo's user permissions model offers granular control over access to product modules, increased control over document-level permissions in the DMS, and the ability to organize users in groups.
The tables below outline Roles available in the system and their access level in each product module (Regulatory, Clinical, etc.)
Regulatory Permissions
| Role | DMS | Projects | Reg Activity | eCTD Viewer | Submission Builder |
| Editor | Edit, Read | Edit, Read | Edit, Read | Edit, Read | Edit, Read |
| Reviewer | Edit, Read | Edit, Read | Read | Read | No Access |
| Viewer | Read | Read | No Access | No Access | No Access |
| Investigator | Read | No Access | No Access | No Access | No Access |
| Inspector | Read | No Access | No Access | No Access | No Access |
| Training | No Access | No Access | No Access | No Access | No Access |
Clinical Permissions
| Role | DMS (eTMF) | Projects | Site Management | CTIS Builder |
|
Editor |
Edit, Read |
Edit, Read |
Edit, Read |
Edit, Read |
|
Reviewer |
Edit, Read |
Edit, Read |
Read |
No Access |
|
Viewer |
Read |
Read |
No Access |
No Access |
|
Investigator |
Read |
No Access |
No Access |
No Access |
|
Inspector |
Read |
No Access |
No Access |
No Access |
|
Training |
No Access |
No Access |
No Access |
No Access |
Quality Permissions
| Role | DMS (Controlled Docs) | Projects | Quality Activity | Vendors |
| Editor | Edit, Read | Edit, Read | Edit, Read | Edit, Read |
| Reviewer | Edit, Read | Edit, Read | Read | Read |
| Viewer | Read | Read | No Access | No Access |
| Investigator | Read | No Access | No Access | No Access |
| Inspector | Read | No Access | No Access | No Access |
| Training | Read | No Access | No Access | No Access |
Corporate Permissions
| Role | DMS (Corporate Documents) | Projects |
| Editor | Edit, Read | Edit, Read |
| Reviewer | Edit, Read | Edit, Read |
| Viewer | Read | Read |
| Investigator | Read | No Access |
| Inspector | Read | No Access |
| Training | Read | No Access |
Other Permissions
| Role | Reports | Training Courses |
| Editor | Read | Course Manager, Trainee |
| Reviewer | Read | Trainee |
| Viewer | No Access | Trainee |
| Investigator | No Access | Trainee |
| Inspector | No Access | Trainee |
| Training | No Access | Trainee |
Detailed Permissions in DMS
The tables below outlines the granular permissions that are available to each role in the DMS. One of two "base permissions" can be set for a role: Edit or Read. These permissions apply to the DMS in any product module (e.g. Controlled Documents in QMS, or eTMF in Clinical)
Edit Permission
Only Editor and Reviewer roles can have edit permission in the DMS.
|
Role |
Create Document |
Edit/Collab |
View Draft Versions |
Upload Version |
Upload to Placeholder |
Allow Download |
Review |
Approve |
Preview |
View Reports Tab |
| Editor | YES | YES | YES* | YES | YES | Download all | YES | YES | Full-featured | YES |
| Reviewer | NO | YES | YES* | YES | YES | Download all | YES | YES | Full-featured | YES |
| Viewer | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Investigator | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Inspector | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Training | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
*Required in order to review or approve
Read Permission
| Role | Create | Edit/Collab | View Draft Versions | Upload Version | Upload to Placeholder | Allow Download | Review | Approve | Preview | View Reports Tab |
|
Editor |
NO |
NO |
YES |
NO |
YES |
Download all |
NO |
YES |
Full-featured |
YES |
|
Reviewer |
NO |
NO |
YES |
NO |
YES |
Download all |
NO |
YES |
Full-featured |
YES |
|
Viewer |
NO |
NO |
YES |
NO |
NO |
Download all |
NO |
YES |
Full-featured |
YES |
|
Investigator |
NO |
NO |
YES |
NO |
YES |
Download all |
NO |
NO |
Secure |
NO |
|
Inspector |
NO |
NO |
NO |
NO |
NO |
No downloads |
NO |
NO |
Secure |
Audit trail only |
|
Training |
NO |
NO |
YES |
NO |
NO |
Download all |
NO |
NO |
Full-featured |
NO |
Download Options
Kivo offers granular controls on document download. Only certain user roles can be given the option to download, but all user roles can restrict download in some capacity. The following options are available:
- Download all - All versions, both source and renditions, can be downloaded by a user. This includes any source file type (Word, PowerPoint, SAS Transport, etc.) and any type of PDF rendition, including signed and unsigned renditions of both draft and approved documents.
- Download only approved PDFs - This limits users to only downloading PDFs of approved documents.
- No downloads - This blocks the download of any version or rendition of a document.
Preview Options
Kivo has two built in document viewers. Our Full-featured viewer offers an improved user experience with the ability to navigate hyperlinks, search, use bookmarks in PDFs, copy text, etc. This viewer accesses the document from Kivo's server and caches it locally to preview.
Our secure viewer streams the content of each page to the user's browsers without caching any information. It also blocks selecting text or printing. It ensures that the user cannot retain information outside of Kivo by retrieving any content from a local cache or copying information from the document.
Our secure viewer is reserved for Investigator and Inspector users, as those roles are typically used by third parties where a sponsor may want to limit the retention of data. Inspector roles are also often used during due diligence to ensure sensitive information is not retained.