Study Workflow is used to define how subject data should flow through user review after being collected. For example, many clinical trials collecting data for FDA submission need data to be monitored and then reviewed by a data manager or study manager. TrialKit allows you to configure the exact workflow your trial needs.
To view/edit the study workflow, tap Study Workflow in Study Configuration:
Once open, you will see the list of existing levels. The following actions can be taken here:
- Reorder the list by tap/hold and dragging
- Delete an item by swiping to the left
- Edit an item by tapping
- Add a new item by tapping New in the middle of the screen
See the definitions below the image for each item on the screen:
Review Level Name - Name of review level set up
Role - The role in the study that is responsible for a particular review level
Form Status - Form Status ID assigned to the review level. The ID 10-14 are reserved for up to five review levels. This code helps distinguish the review level in the database for reports in Data Management.
Field Level Source Verification - Checking this field will allow the role the ability to do field level review. This includes risk-based monitoring if the study is set up to support it.
Require Electronic Signature - Checking this field requires Electronic Signature for this role review to be completed.
Soft Review - This allows a review level to perform an initial review on forms that may be incomplete or have open queries. This only makes sense to use on the very first review level. For example, a Monitor may want to perform initial/soft review and then come back around for a second pass, or final review. Note, this cannot be used on a review level that also does Field Level Source Verification.
Description - Review level description text that will appear on form when applied.
Add/Update Review Level button - Don't forget to save by tapping the Update Review Level button.
Done - If you have not saved the form, ** will appear next to Done, indicating you must save. You will be prompted to save.