Stack 18: What's New?
eConsent
Allows Participants to sign Informed Consent forms with 21 CFR Part 11-compliant signatures. Investigators and CRCs can add 21 CFR Part 11-compliant countersignatures from the Participant Details Page. Provides new tools for tracking the consent status of participants and an audit trail of all informed consent activity. PDF copies of signed eConsent forms can be downloaded by Participants as needed.
Annotated CRFs (aCRFs)
Allows Data Managers to create individual blank annotated form PDFs and blank annotated Casebook PDFs which contain all forms in the study. Any form published to Study Runner can be downloaded as a PDF with annotations describing the form definition. This supports annotated forms needed for review during study design and as part of data submission or analysis after data collection. Individual annotated forms can be created from the CRFs page and annotated Casebooks can be created from a new page in Study Runner.
Study Calendaring
Provides new ability to use Form Action, Event Action, and Participant Action rules to automate Participant Calendars. The Participant Details Page is updated dynamically to reflect the results of the rules as they run. This allows study designers to make Forms editable, visible, and/or required based upon changes to Event data, Form data, and/or Item data in the study. In addition, Events can be scheduled, locked, or have their statuses change based on a data change. This functionality can be based on breaking your study into epochs, representing time periods within the study such as "Screening", "Treatment", and "Follow-up", and calendars representing different study arms or cohorts. This feature is available as a pilot with Stack 18, but is planned for general availability for Stack 19.
View Queries Icon and SDV Status on Participant Details Page
A Query bubble icon was added to form cards on the Participant Details Page for forms that have open queries assigned to any items on the form. The Source Data Verification (SDV) status is also visible as an icon on the form cards. This allows users to easily identify if they need to respond to any queries or complete SDV at a quick glance while on the Participant Details Page.
SDV Verify on the Participant Details Page
The SDV Verify action was added to the form card action menu on the Participant Details page to allow Data Managers and Monitors to more easily verify forms. This allows forms to be verified while on the Participant Details Page without the need to navigate to the Source Data Verification page to perform the action.
Direct Access to Specific Events on the Participant Details Page
Updated the Help Widget Icon
The white icon on the orange help widget was updated from a question mark to a broadcast icon to help differentiate the icon from other similar icons within OpenClinica.
Added Accessibility Statement Links
Accessibility Statement links were added to Study Manager, Study Designer, and the Participate dashboard. The Privacy Policy link was also added to the Participate dashboard.
Allow Data Managers to See Jobs From Other Users
Updated the Bulk Actions log to show all jobs for Data Manager roles as long as there is no Participant data within the job output regardless of who ran the job. The jobs will be restricted by whether the Data Manager user has Site-level or Study-level access. Data Managers will still only be able to see jobs that they have initiated if Participant data is included in the job results.
Automatic Queries
Updated the form engine to prompt data entry users on whether they would like to add automatic queries for standard soft required and constraint errors when marking a form as Complete. Previously, automatic queries could be added for items with constraint errors only when closing a form (not changing it to Complete status) and automatic queries could not be added for missing required items prior to marking a form as Complete.
Performance Improvements, Enhancements, and Bug Fixes
General performance improvements, usability enhancements, bug fixes, and security enhancements have been added throughout OpenClinica. Notably, workflow improvements have been made for the Data Dictionary, Data Review Tables, and Insight.
See full release notes for Stack 18 here.