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Issues (Edit Issue (Quick links (Add action item, Downgrade pd to issue…
Issues
Edit Issue
We can not edit the issue type at the SE and SEC level. This is editable in the SES level
Severity
Category
Subcategory
Description
Add subjects
Root cause description
Occured date
Discovered date
Status
Assignee
Action items
Assigned to me
Created by me
Subjects
Comments
Required notifications
If PD issue
Key activity
Linked to
Quick links
Add action item
Downgrade pd to issue /upgrade non pd to issue
Change issue to external
Can edit
Types : 1. Protocol deviation issue
2. Non-protocol deviation issue
Issue Listing
Issue ID
Icons are visible based on
study level issue,
country level issue,
site level issue and
subject level issue
Issue create under site but not associated with subjects will become site level issue
Issue create under site but with subjects associated to it will become subject level issue
issue Type
Protocol Deviation(PD)
Non-Protocol Deviation(NPD)
Category
Sub-category
Created date
Status
Severity
Description
Subject
Assignee
Study
Country
Site
Filter by
Type
Protocol deviation
Non-Protocol deviation
Status
Assignee
Visibility
External
Internal
Issue level
Study level
Country level
Site level
Subject level
Unblinded
Blinded
If an issue is un-blinded , there exists a label below the issue ID on the issue listing page
If an issue is blinded , there will be no label below the issue ID on the issue listing page
Quick links
Create issue
Bulk Reassign
Issue creation
We can not create issues at CD level
Create issue
Issue Type
Issue visibility
Severity
Category
Subcategory
Description
Add subjects
Root cause description
Occured date
Discovered date
Assignee
Bulk Reassign
This feature allows you to reassign all non-closed issues to a single assignee
Re-assign to
Reason for change
Only at SE and SEC level
Include the endpoints
Issues API
https://github.com/mdsol/mcc-issue-api/blob/develop/doc/contracts/openapi.yaml
Aggregator API
https://github.com/mdsol/mcc-sm-aggregator/blob/develop/doc/contracts/openapi.yaml