The study Workflow section is used for a couple of things:
- To set up the review process for a study. In other words, once a form is entered by a user, what cycle of reviewing and a 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 and variables in the study serve a few key functions (Registration, Study Exit, etc) for the purposes of tracking and reporting.
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. Be sure these are sequential and not skipping values
2. Name - Name of review level set up
3. Role - Role of the reviewer to the system
4. Status - Form Status ID assigned to the 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. This is an important point to keep in mind when making workflow changes on a live study.
5. Field - Checking this field will allow the role the ability to do Partial Monitoring of forms.
6. Sign - Checking this field requires Electronic Signature for this role review to be completed. eSignature types are displayed in the audit trail and exports along with the user and date.
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. Enrollment Trigger (NEW) - This is the form and corresponding variable (boolean) and value which will count each subject as "enrolled" in the study. This may be the same as registration in many cases, but may also be later on, such as the case with screening subjects (registration) and later on enrolling them upon randomization, for example. This variable is displayed in the dashboard for the number of subjects and TrialKit Site Progress export.
11. Deviation form - Indicate which form will serve as a deviation form. These are counted in the dashboard report
15. Adverse Event Field - This is the field (must be a choice field) you want they system to use specifically when counting the number of AEs in various reports. If this is not set, it will default to simply use the form defined above.
16. Adverse Event Value - This is the value of the Adverse Event Field selected above that will true a "true" response - or a count in this case.