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. Be sure these are sequential and not skipping values
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. This is an important point to keep in mind when making workflow changes on a live study.
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.
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.