Defining study workflows

Defining a study's workflows involves detailed planning around the order in which sites complete individual workflow tasks and identifying required documentation and communication.

Depending on your role, you may be responsible for defining the tasks that sites complete and the order in which the tasks are made available to site. If you have the appropriate permissions, you'll define the workflows using the Manage site workflow configuration page options. Note that some organizations define workflows using account-level templates.

Step 1, Add the workflows required for this study, allows you to move a workflow to Step 2 by clicking the plus sign. In Step 2, you'll add a close date for the workflow(s) and set a default workflow. Workflows available to you in Step 1 may be the default system workflows or preconfigured, account-level workflows that include specific tasks. If using an account-level workflow, you can modify it as necessary for the study, but your changes will not affect the account-level workflow template.

You'll specify a unique workflow name (40 characters max) in Step 3. You'll also optionally enable other workflow details (e.g., digital signature and site collaboration, workflow description, and more). If preferred, you can also apply Rich Text Formatting to text that displays to site users in Oracle Site Select LITE. (i.e., the workflow description and closing message).

Next, you'll see the option to Override the default and country-specific email templates for studysites assigned the workflow. If you enable this optional setting, the form expands to include new fields where you will create workflow-specific email templates for the invitation, final acceptance, and final decline emails. For each template, options match those available on the Study email template settings page, including the ability to use placeholder values in the text area and preview the template. When studysites are assigned to a workflow with the Workflow-specific email templates option selected, the following email sending behaviors apply:

• For that workflow, Oracle Site Select will use the configured templates at the workflow level for the invitation, re-invitation, final acceptance, and final decline emails
• A site reassigned to the workflow will not receive a new invitation email with the workflow-specific email template. However, if the site is later re-invited to the study, then they will receive the workflow-specific email invitation
• Email templates will not include a No login link if the Manage study email templates page has that option configured at the level in which the site would receive an email template (default vs. country override)
• Email template salutation and personalization preferences will follow the configured study email template preferences based on the applicable default or country override

The lower section of the Manage site workflow configuration page includes workflow tasks. In the Site task library, at the left, click a plus sign to add that task into the workflow list on the right side. Once all the tasks are in the panel at the right, you can reorder them as necessary by using the up and down arrows to relocate tasks into the preferred position. You can also optionally change a task name that is displayed to sites and format task information as preferred.

A checkbox configuration option will allow site users to complete certain tasks at any point in their assigned workflow. All site and internal workflow tasks include this option: “The task becomes due after this task is completed.” The option is enabled (checked) by default, which means the next task in the workflow will show only when the site completes the current task (a.k.a the task is "gated"). You can uncheck the box if preferred so that completing that workflow task is not required to proceed in the workflow.

Some tasks include unique functionality. For instance, if you choose to include "Verify site interest," "Verify site interest again," and/or "Agree to confidentiality statement" workflow tasks, and a site answers No for any of those tasks, the site will be prevented from previewing or moving to the next task unless they change their response to Yes. This is by design.

When sites answer No, the icon status of the workflow task on the Oracle Site Select site progress tab and in Oracle Site Select LITE displays a red "Discontinued" icon: When an Oracle Site Select LITE user answers “No” to a task that action then removes them from consideration (Verify site interest, Confidentiality statement, or Verify site interest again), and the following message displays for the site user:

“Your response to the current task is preventing you from continuing on with this study. If you would like to resume participation, please accept the terms of the current task.”

If you include the Sign and return CDA task, you can optionally enable a "Send the finalized CDA as an attachment to all study contacts" check box. When the task setting is enabled and the CDA is fully executed, Oracle Site Select sends the CDA as an attachment to the completed CDA email notification in the same document format as the finalized CDA. The document attachment will also be included in the site communication copy (archive) email if this option is enabled in the study email template settings.

When you include a Generic document task, specify one of the Action Types below. To help you choose the appropriate type, Oracle Site Select displays related subtext depending upon the value selected:

• Download required (default) – Use this action type to provide information to the invited site. A document template will be provided to the site. The task only requires the site user to download the file then click Done to complete the task.
• Approval required – Use this action type to require an uploaded document from the invited site. A document template will be provided to the site. The task requires the site user to download the file, then upload a file in response. The task will complete when a Select document reviewer approves the uploaded file. A rejection will require the site to upload a new file.
• Choose response – Use this action type to require the site to review a document and choose a response. The task requires the site user to download the file and choose their affirmative or declination response. Either response will complete the task.
• Attestation required – Use this action type to require the site to review and attest to a document. A document template will be provided to the site along with attestation text. The task requires the site user to download the file, review the attestation text and choose their affirmative or declination response. An affirmative response is required to move on to the next task if the option "The next task becomes due after this task is completed" is selected.

The "Internal workflow task" is another with special functionality. A site assigned to a workflow with an Internal workflow task will see the task in their Oracle Site Select LITE task list, and their workflow will be paused when they reach it. The task's configured "Site display information" displays during this pause, and that message will be removed when an Oracle Site Select user completes the task.

Please note, if the site reaches their Internal workflow task but also has an ungated Generic document task pending completion, Oracle Site Select LITE will show both task's information with the Generic document task below the Internal workflow task. The internal task will halt the workflow, but the site can still complete the Generic document task.

In Oracle Site Select, the Complete tasks on behalf of site page lists the Internal workflow task in the configured workflow order. When the user clicks the Complete button, a modal displays the task's configured "Task information" text. That user must include an entry in the modal's Task response text field before clicking Submit to complete the internal workflow task and allow the site to resume the workflow.

• Configure workflows for sites
  Set the workflow's attributes and close date and set up the tasks you need sites to complete and the order in which they must complete those workflow tasks.
• Configure account-level workflow templates
  If you have account setup permissions, create account level workflow templates to standardize workflows across your studies. Templates are available in the study workflow template library when setting up your study workflows.