Stack 12: What's New?
Event/Form Actions and Statuses:
We are using a new status data model to provide more clarity on Event and Form statuses. In addition to the Workflow Statuses of Not Scheduled, Scheduled, Data Entry Started, Stopped, Skipped, and Completed Events can have the following independent statuses: Locked, Signed, Removed, and Archived. In addition to the Workflow Statuses of Not Started, Initial Data Entry, and Complete, Forms can have the following independent statuses: Removed and Archived.
The statuses can still be changed on the Update Event screen as before. In addition, buttons for Lock, Unlock, and Sign have been added directly to the Participant Details screen for eligible users. Remove is still available from many study screens, and Archive is still available from the Study Designer interface.
If an Event has a Workflow Status and other statuses, for example, Completed, Locked, and Signed. The Status column displays Completed with icons for the Locked and Signed underneath. If an Event is removed, then Removed will replace the Workflow Status.
Form statuses are similarly indicated by a Workflow Status and additional icons for other statuses. If a Form is currently using a Form Version that has been archived, an Archived icon is displayed next to the Form Version. This applies to the Participant Matrix, Participant Details screen, and Enter or Validate Data screen, which is used for viewing single Visit-Based Events.
Note: In the ODM schema, OpenClinica:Status for Events and Forms has been deprecated. It has been replaced by OpenClinica:WorkflowStatus, OpenClinica:Archived, OpenClinica:Removed, OpenClinica:Signed, and OpenClinica:Locked. For compatibility, the OpenClinica:Status ODM attribute will continue to be maintained for at least 3 months. Customers using integrations with OpenClinica or otherwise consuming the ODM data directly should make appropriate updates to stop using OpenClinica:Status during this time. All the same information is included in the new status model, but with more flexibility and precision.
A new Form action, Clear Form, has replaced the Delete action. This clears all data in the Form, but audit history is retained. Once the icon is clicked, the Form status becomes Not Started.
SDV with Item-Level Data, Additional Columns, Actions, and Statuses:
When a Form that was verified has any data changed, it will automatically update to Changed since Verified status. Status filters in the SDV column have changed to Verified, Ready to Verify, Changed since Verified, and Ready to Verify + Changed since Verified.
The new column, Open Queries, displays the number of open queries for the corresponding Form. You can go to the Queries screen by clicking the number of open queries.
The existing CRF Status column displays icons according to the new status model described above.
You can now click the Data button to view item-level data for any Form in the SDV table. This view includes the following for each item on the Form: current value, number of open queries, last modified date, last verified date, and a link to open the Form directly to the item. This view automatically defaults to showing only items that have been changed since the Form was last verified.
Navigation for Data Managers and Administrators:
Data Managers and Administrators can now navigate from the current study in Runtime to the Study Build System for the same study by clicking links at the top of the screen.
Scheduled Extract Jobs:
Users with a User Type of Admin can configure extract jobs to run daily, weekly, or monthly. The resulting datasets can be downloaded via the Datasets screen as well as via API. The new APIs for working with Scheduled Extract Jobs are available from the Web Services Information screen.
Import Tabular Files (Excel, CSV, Pipe-Delimited, SAS):
The Import Data link on the Tasks menu now goes to a screen that includes a link to import Tabular files in addition to a link to import XML files.
For Tabular files, the type of delimiter (for example, pipe, comma, or tab) can be set in the Data Mapping Template along with other import configurations and the mapping between the Data file and the items on your Forms. After a Tabular import job is completed, a log of the results is accessible from the same page.
Insight:
Insight has a new UI and new Report Builder with the ability to join tables without using SQL.
Note: In addition to other changes being made to columns in Insight data tables, the study_event_status_label column for Event statuses and event_crf_status_label for Forms statuses have been deprecated. They have been replaced by columns named label in their respective status tables, and archived, removed, signed, and locked in the Events/Forms tables.
Likewise, the sdv_status column will be replaced by the column label in the event_crf_sdv_status table. For compatibility, the study_event_status_label column, event_crf_status_label column, sdv_status column, and other deprecated status columns, will continue to be maintained for at least 3 months.
Customers using the study_event_status_label or event_crf_status_label column in reports should make appropriate updates to stop using this column during this time. All the same information is included in the new status model, but with more flexibility and precision.
Since these columns may be widely used to monitor progress, they may be among the most impactful, but there are other columns that will also be affected. A full list of the changes being made to Insight table structures and guidance on how to update your existing Questions to prepare for the deprecations will be provided with the upgrade.
Performance Improvements and Bug Fixes:
- Form loading improvements for existing Forms that already contain data
- Loading improvements for the Participant Matrix
- Loading improvements for the Enter or Validate Data screen
- PDF Casebook improvements, such as formatting and including the site name in the header
- Administrators can find users more easily from the Administration screen
- Updates query workflow so that only Data Managers and Monitors can reopen closed queries
- And many more enhancements and fixes too numerous to list.
See full release notes for Stack 12 here.