The study Workflow section is used for a couple things:

  • To setup the review process for a study. In other words, once a form is entered by a user, what cycle of reviewing and signature does it go through. Commonly, this includes at least a Monitoring stage and a sign off stage by an Investigator or Data Manager.
  • To teach the system which forms in the study serve a few key functions (Registration, Study Exit, etc).


On a web browser:

Select Study Configuration from the study menu, and select the Workflow tab highlighted in the image. 

1. Order - Set review order of roles
2. Name - Name of review level set up
3. Role - Role of reviewer to system
4. Status - Form Status ID assigned to review level.  This is the code for each review level in data extracts. The example below is not sequential because the initial verification level was added later in the study. To prevent the system from changing any current records, the original statuses were maintained. 
5. Field - Checking this field will allow role the ability to do Partial Monitoring of forms
6. Sign - Checking this field requires Electronic Signature for this role review to be completed.
7. Soft - Can only be selected at the first review level. This allows the first level to mark something as reviewed regardless of the form current status (open queries or missing data). This is useful for Monitors who perform monitoring before forms are completed. Any changes made to a form after the soft review is made will automatically remove the status. This is logged in the audit trail and Monitor Report. Caution: Existing studies that already contain data and would like to add this function should be cautious to not alter current workflow status values. See the example below on how this is accomplished. See below example of soft review tag.

 

8. Description - Review level description text that will appear on the form when applied.



The bottom section of the Workflow is where users define basic forms for the system to use in controlling various elements. 


9. Registration form - The form from the form builder that will serve as the initial enrollment or registration form to create a new subject profile ID. This item will be grayed out and cannot be changed if there are subjects in the database. In those cases, clear the data or create a new copy of the study to change the registration form.


10. Deviation form - Indicate which form will serve as a deviation form.

11/12. Withdrawal form - Indicate which form from the form builder will serve as the withdrawal form (e.g. study exit or discontinuation). The system uses the date on this form to make any visits beyond that date inaccessible to the site and subjects in ePRO. A description field can also be identified which is displayed on the subject's records page after withdrawal. The form defined here will also discontinue possible ePRO forms to the patient.

13. Medication log - Indicate which form will serve as the medication log.

14. Adverse event form - Indicate which form will serve as the adverse event form.

15. Save Study Configuration - Remember to save the configuration after making any changes.