Signals Clinical: Raising and Closing queries to Veeva or to Rave EDCs will sometimes fail

Background:

Signals Clinical (SCL) presents to the user (the Medical Reviewer) the Review Listings of your Study. You can raise an Issue with any of the rows in your listing. If that row's data originates from a Veeva system or from a Rave system, then the SCL user can raise a query for that issue. Such action creates a query in Veeva or in Rave (in the 'EDC'). Such query is viewable in both the EDC and in SCL.

After the query gets 'Answered', it becomes close-able in SCL, within the documented constraints (Help: Line Listing Review > Reviewing Line Listings > Posting a Query. Section: "To close a Query in Veeva® (EDC)" ).

There are many scenarios where the above functionality might fail. Capturing and reporting the on-screen error will facilitate identifying and resolving the cause of failure.

Detail:

Whenever query interaction with an EDC fails within the webpages of SCL, it is important to capture the maroon-colored box that usually appears in the lower right corner of your browser window. Ideally, it is best to record an on-screen session of your experience and then share it with your team. Several flavors of these boxes might appear, and the message contents help indicate a root cause and an appropriate solution.

To resolve any of these possible scenarios, you will need support from some combination of an SCL study admin, an SCL system admin, a Veeva or Rave (EDC) admin, a Spotfire admin, and / or Revvity Support.

Below is a summary of documented restrictions for Veeva and for Rave query actions that are initiated in SCL. SCL is limited in its ability to perform an upfront check of the EDC content and configuration, so quite often an unmet restriction is not known until the SCL user triggers the action in SCL. Further restrictions can be configured in the EDC, which it enforces and SCL is not aware of; an EDC's unmet restriction is not known until the SCL user submits the action in SCL.

-A user who opens a query cannot answer it.
-A query must be answered before anyone can close it.
-A user who opens a query can close it (after it is answered).
-A user who answers a query can close it.
-No other user can close it from SCL
-A query created in Veeva cannot be closed in SCL, by any user.

Solution:

The below list contains a screenshot of messages that SCL might report on-screen, along with recommendations to resolve the root cause of the message. Each scenario might occur when failing to create a query or when failing to close a query. This list is likely to be not exhaustive.

User is missing the required permissions in the Veeva or Rave EDC to either create or close a query.

This message indicates that your user account in Veeva or in Rave has not been adequately configured for this integration. You will need a Veeva or a Rave administrator to get this issue resolved. Note that the EDC administrator needs to grant the required permissions to both the user's account to the user's API profile, and the specifics vary between Veeva and Rave. See documented permission requirements in the SCL Help pages at 'Line Listing Review > Reviewing Line Listings > Posting a Query'.

2. Veeva or Rave authentication login is not successful.

This error can occur when either raising or closing a query. There could be many reasons as to why authentication fails. You will need an EDC administrator and an SCL System Admin to get this resolved. A key question is whether or not any users can authenticate to Veeva or to Rave from your SCL tenant, which will indicate whether or not this issue pertains to a specific user or to all users.

Your user account might not exist in Veeva / Rave, or might no longer be active in Veeva/ Rave. This message indicates a Veeva or Rave OAuth user lookup failure. When working with Revvity Signals Support, please call attention to the SCL-8709 issue in Jira.

3. Attribute mappings in the SCL study are missing.

This message indicates that your study's attribute mapping is incomplete for this integration with Veeva or with Rave. You will need an SCL Study Admin to get this issue resolved. See documented permission requirements in SCL Help at 'Line Listing Review > Reviewing Line Listings > Posting a Query'. Section: To post a query in EDC (Medidata Rave® / Veeva®). The required list of mapped measurement attributes differs between Rave and Veeva.

4. The query may have been created in the EDC.

A known scenario in which this message has been seen is a query was created in Veeva, then the user views it in SCL, and tries to close it from SCL. By design, queries viewed in SCL can be closed in SCL only if the query was created from within SCL.