The below instructions describe the process of creating new user groups, and then setting group access for:
Clinical*
- eTMF cabinets
- Sites
- CTIS Builder
- Trial Management (Projects)
Regulatory*
- Regulatory cabinets
- Regulatory Activities
- Submissions Builder
- eCTD Viewer
- Regulatory Projects
Quality*
- Quality cabinets
- Quality Activities
- Vendors
- Quality Projects
Corporate*
- Corporate cabinets
- Projects
Create new user group
- Select Create Group
- Define Group Name
- Define group permissions per above*, as well as for the Training Module and Reports
- Add new group to relevant users
Assign new group to relevant (specific) cabinets, activities, projects, submissions and eCTDs:
1. Cabinets
- For cabinets that house content, navigate to the Regulatory, Clinical, Quality and/or Corporate modules and enter Manager Mode.
- Select the ellipsis icon of each specific cabinet and select Edit.
- The cabinet settings page will open. Under Permissions for "Cabinet Name", select Groups and select the new group and select Add Group.
Define cabinet specific permissions for the added group:
- Cabinet-specific Role
- Approve - Allows users in group to approve (finalize) documents
- Create Files - Allows Editor users in group to create and delete placeholders, upload and create documents without placeholders, and create folders based on cabinet templates.
- Upload into Placeholder - Allows Viewer users in group to upload documents into placeholders.
- Can View Unblinded Data - Allows users in group to view unblinded documents. Allows Editor users to set uploaded documents as unblinded.
2. Activities, Vendor and Sites
- For Regulatory Activities, Quality Activities and Vendors, and Investigator Sites that track related events/data, navigate to:
Regulatory > Regulatory Activity
Clinical > Sites
Quality > Vendors or Quality Activity
Example:
- Enter Manager Mode.
- Select Access on the top-right.
- The Permissions settings page will open. Under Groups, select Add Group.
- Select the new user group, define subtype(s), define if group users should be Editors, and then select Add Groups.
- Group is added as defined.
3. Projects
- For projects , navigate to the Regulatory, Clinical, Quality and/or Corporate modules:
Regulatory > Regulatory Projects
Clinical > Trial Management
Quality > Quality Projects
Example:
Corporate > Projects
Example:
- Enter Manager Mode
- Select the user icon of each the relevant Categories, Types or/and Projects.
- The Permissions settings page will open. Under Groups, select Add Group.
- Select the new user group, define if group users should be Editors, and then select Add Groups.
Notes:
Projects - group access can be set at the Category, Type, and/or Project level.
- Adding a group to a Category will give the group access to all corresponding Types, and Projects.
- Adding a group to a Types will give the group access to all corresponding Projects.
4. CTIS, Submissions, eCTD
- For projects , navigate to the Regulatory and/or Clinical modules:
Clinical > CTIS Builder > Category: Product
Regulatory > Submission Builder: Category > Product > Application > Submission
Regulatory > eCTD Viewer: Category > Product > Application
Example:
- Enter Manager Mode and select the user icon of each the relevant Categories, Types, Applications or/and Submissions.
- The Permissions settings page will open. Under Groups, select Add Group.
- Select the new user group, define if group users should be Editors, and then select Add Groups.
Notes:
CTIS Builder - group access can be set at the Category and/or Product level. Adding a group to a Category will give the group access to all corresponding Products.
Submission Builder - group access can be set at the Category, Product, Application and/or Submission level.
- Adding a group to a Category will give the group access to all corresponding Products, Applications and Submissions.
- Adding a group to a Product will give the group access to all corresponding Applications and Submissions.
- Adding a group to a Application will give the group access to all corresponding Submissions.
eCTD Viewer - group access can be set at the Category, Product, and/or Application level.
- Adding a group to a Category will give the group access to all corresponding Products and Applications.
- Adding a group to a Product will give the group access to all corresponding Applications.