Site grid

Oracle Site Select introduces a new site grid drawer component with workflow tasks and site notes, you can now download docs from Step 4, and Reasons are now included in exports containing Site notes and Site comms and notes columns.

Workflow tasks in site grid drawer

When you have permission to complete tasks on behalf of sites, you’ll see a new Workflow option in the site grid Actions menu that opens a new site grid drawer component from the right side of your screen. The drawer defaults to the Workflow tab and includes a Site notes tab (described below), which you do not need explicit permission to access. At the top of the drawer, you’ll see the Investigator’s first name, last name, and Institution name as well as the site's assigned Oracle Site Select user. You can update the site assignment, if necessary, using the "Site assigned to" control.

Please note that Oracle Site Select users with the read-only site grid permission can view the site's Workflow tab, but actions are disabled because these users do not have the appropriate permission to make an update to the site.

Assigned workflow and close date

When the site’s assigned workflow has a defined close date, you’ll see the date just below the site assignment control. Hover over the more information icon () to see a countdown with the number of days remaining before the workflow closes. If you prefer, you can remove the workflow close date.

You can reassign a site to a different workflow if you have the required Site nominate permission. Click the "Select workflow" drop-down to see an alphabetical list of available workflows, and choose the workflow to assign. Oracle Site Select will display the following text in a confirmation window so that you’re aware of the impact of the reassignment:

“Please confirm that you wish to reassign the site to the <WorkflowName>workflow.

Any tasks that have been completed in a site's current workflow will need to be completed again in the new workflow.

If there is an assigned survey change, the site's survey status will be reset and scoring will be determined by the site's responses to the new survey if applicable.

Last completed workflow task:<LastCompletedTaskName>"

For a site that has been assigned a workflow but has not yet been invited, the task list will only contain the helper text "The workflow tasks for the site will be created when the site is invited to the study."

Workflow tasks

The Workflow tab shows each task in the site’s assigned workflow and task details (like task status, related dates, etc.). As applicable, each task has a status icon (e.g., green check for completed, dash for not started, red slash for discontinued), and workflow tasks also use color background to enable quick review. Task colors are:

• Green = Completed
• Yellow = Pending
• Beige = No action (e.g., no pending document)
• Rose = Discontinued
• No color = Not started

You’ll also see the Response: + the saved value for Completed tasks with an input. For instance, the Verify site interest task will display a line with Response: Yes (or No), while the Enter estimated patient count task will show a field with the site’s inputted numeric value.

Complete a task on behalf of the site

Release 24.1 includes enhancements that allow you to complete the following tasks on behalf of a site from within the Workflow tab:

• View site profile
• View protocol
• Generic document (Download only; use Document approvals page for Approval required, Choose response, and Attestation)
• Verify site interest and Verify site interest again
• Feasibility survey
• Enter date available for site visit
• Enter estimated patient count
• Internal workflow task

Click a task's Actions button to view available completion options for that specific task. For example, an enabled Actions button for the Verify site interest task includes options to Verify Yes, Verify No, and Complete – Not required. Some tasks will include document or template download icons (e.g., View protocol, Complete feasibility survey) as appropriate.

With release 24.1, you can only complete the document tasks listed below as “Completed - Not required” in the workflow drawer view. To manage the following Document tasks, please use the Document approvals page:

• CDA document
• Agree to confidentiality
• Generic document (Approval required, Choose response, and Attestation)

Note that if you re-complete or re-submit a completed workflow task within the workflow tab, you’ll replace the existing submission and be marked as the submitting user. Please confirm this action in the confirmation modal.

Currently, a document task completed as Not required will not have the site listed on the Document management page, Approved tab. This is intentional since the document was not "Approved" but rather bypassed.

Tip:

We plan to continue enhancements to the site grid drawer's Workflow tab in future releases.

Epic: SEL-16396

Site notes tab in site grid drawer

The site grid drawer, described above, also includes a Site notes tab. If you don't already have the site grid drawer opened, you can navigate directly to the Site notes tab when you click View notes in the site grid Action menu. By design, when you click on a site's notes icon in the site grid, the Notes modal displays instead of the site grid drawer. In this scenario, the modal defaults to the Study Notes tab.

When viewing the Site notes tab in the drawer, you'll use Oracle standard components for field and text inputs. You can optionally filter the Notes history section by name, date, or note text. The Notes history section shows notes in the previously defined format, meaning:

• Notes include the author's full name and listed in order of input occurred at datetime
• Format: <occurred date time> * <bucket - bucket state note was recorded> * Recorded at: <note saved date and time>

The Site notes tab also includes a note input section at the bottom, which provides all previously available site note functionality for date, label, and text inputs.

Note:

This release also includes other significant Notes enhancements (such as note versioning). See the Site notes chapter in these release notes to learn more about new features and functionality for Site notes and Reasons for site exclusion notes.

Epic: SEL-16396

Site document download

You can now download site documents from Step 4 Final acceptance and Final decline buckets. We added this option to the Actions drop-down list, and the feature works as it does under Step 3.

Epic: SEL-16363

Site note extract column

On the Site note and the Site comms and notes digest columns, each line that exports a site's disinterest or exclusion reason now includes the selected reasons and any inputted "other" reason text. When multiple reasons exist for that line, they are separated with a semicolon.

Epic: SEL-16363

Agree to confidentiality response column

With release 24.1, we added a new Agree to confidentiality response column that shows the saved response for the Agree to confidentiality workflow task. You can add the new column to the site grid using the site grid column picker, and you can filter the response (Yes or No) if preferred. You can also export the column to CSV and Microsoft Excel via the site grid extract utility.

Please note that when a site is reassigned from a workflow with a completed Agree to confidentiality task to a new workflow with the same Agree to confidentiality workflow task, the task’s status will be incomplete in the reassigned workflow, but the previous response will be saved. After you (or another Oracle Site Select user) complete the new workflow's task, the Agree to confidentiality task column data will update to reflect the new response value.

Epic: SEL-16363