Defining the flow of data through review and signatures
This articles describes the study workflow process and how it can be configured for various requirements that a study or registry has for record review and sign off.
As records are entered into a database, they progress through this defined workflow. By default all records will apply to these rules, with the exception of the following scenarios:
- The form is omitted from one or more review levels. Read more about this in form building properties
- The user's role at a given workflow level has permissions to bypass their review
Prerequisite: For the steps covered in this article related to configuring workflow, the user must have access to study configuration, workflow
For steps related to conducting review of records on a given workflow, users must have the assigned role for the level being executed.
Workflow configuration is found under the study configuration menu.
Set an order of sequence that should be followed for the workflow, up to 5 levels.
For each level provide a name and assign the user role responsible for that level.
Status - This is a value that will be used by the system to set the status of a record as it passes through that workflow level. These will be seen in the data exports. Any value 10-19 can be used. Normally it makes sense to start at 10 and go sequentially as shown in the image above.
The status value should not be changed when a study is live. This can alter the meaning of records which have already progressed through review levels.
Field - Check this if the workflow level is responsible for field-level source verification. Read more below.
Sign - Check this if the user needs to provide electronic signature when applying their review.
Soft - This is only available at the first workflow level. It allows the user to 'Tag' records as reviewed even if open queries still exist. Without this, records are not available to enter that first workflow level until all queries are resolved.
Configure a study for Partial Monitoring - Field Level Source Verification (FLSV)
Partial Monitoring allows Monitors (or any needed review level) to review/lock fields individually on records. This prevents any data changes on specific fields of a form but leaves the remainder of the form available for a site to complete data entry.
To configure a study for partial record review, follow the points below:
- Check the "Field" checkbox next to the applicable review level as described above. This is typically done for the first reviewer.
- In the Form Builder, define which fields on the forms will support partial review for the role selected above. Any field that should be capable of being individually locked on a form needs to have the property selected.
Alternatively all fields on the form can be enabled or disabled for this property.
As records are entered in data entry and they progress to the corresponding review level, the reviewer will see a 'lock' icon next to those fields. Read more on Monitoring and Data Review to learn more about that process.