Presented by: Alicia Goodwin Welcome Presented by: Alicia Goodwin OpenClinica Welcome

OpenClinica Technologies Product Roadmap What we’re doing now What to look forward to in the future: https://docs.openclinica.com/release-notes Participating in the community Ideas for getting involved Plugins around APIs OpenClinica Welcome

OpenClinica Long term roadmap Patient Centric Research Participant Portal Calendaring Mobile Device Phase II, III Coding Randomization Data Entry Configurable User Roles Consumable, friendly, self-service Study Portability Modularization Strategy Fully automated system (Validation, Quality system)

Just out: OpenClinica 3.1.4 is out! LDAP Print CRF Expanded browser support These are the building blocks for the next generation of OC: Enhancements to ODM RESTFul architecture ODM to JSON

Light Weight Directory Access Protocol(LDAP) Users 3.1.4 is now enabled for use with LDAP authentication. Starting from OpenClinica 3.1.4, OpenClinica can be set up to authenticate users against an LDAP/Active Directory server to support single user accounts across the multiple applications and systems used in the organization.  The integration with an Active Directory server supports the following capabilities: Querying available Active Directory accounts within OpenClinica Assignment of study roles and user privileges within OpenClinica Authentication of username and password via Active Directory

OpenClinica 3.1.5 Printable Subject Case books 1st generation of Patient Calendaring Stack upgrade (updated versions of Tomcat and PostgreSQL) Enhancements and fixes to Rules engine i18n enhancements and fixes Additional CRF upload validations

Printable Subject Casebooks Printing Subject Casebooks Entire casebook for individual subjects Casebook for all subjects at a site Casebook for all subjects in a study Printing with Discrepancy note and Audit history

Print Casebook

CRF with Data

Print with Discrepancy Note and Audit

Study Calendaring New calendaring functionality Advanced calendar functionality Visit windows Repeating visits, conditional visits Reminders and messages Multiple calendars Schedules based on group

Study Calendaring

Technical Details Rules based Infrastructure (XML based configuration) Sample Rule: <RuleAssignment> <!-- The target is Study events target date, So i want to trigger this when this start date changes. i.e the event is updated--> <!-- The Study Subject object and it's property. How do we refer to the propert names ?? enrollmentDate or A specific Study Subject object represented by its OID and it's property --> <Target Context="OC_RULES_V1">SE_TREATMENTVISIT1.dateStarted</Target> <RuleRef OID="RULE1"> <!-- Called this event action, not the final that's for sure but to give us an idea of what i'm changing --> <InsertAction IfExpressionEvaluates="true"> <Run Batch="false" ImportDataEntry="false" DoubleDataEntry="true" InitialDataEntry="true" AdministrativeDataEntry="true"/> <DestinationProperty Value="" OID="SE_TREATMENTVISIT2.dateStarted"> <ValueExpression>SE_TREATMENTVISIT1.dateStarted + 4</ValueExpression> </DestinationProperty> <DestinationProperty Value="scheduled" OID="SE_TREATMENTVISIT1.subjectEventStatus"/> </InsertAction> </RuleRef> </RuleAssignment>

Calendaring Let’s have a look at “Jikan”…

Stack upgrade Tomcat: upgrade to 7 Postgres: upgrde to 9.2 Overall performance improvements Postgres: upgrde to 9.2

Enhancements and fixes to Rules engine Expose additional variables (e.g. Dates) Fixes around relative vs. absolute paths

Additional CRF upload validations As OpenClinica moves to a more meta-data model and relies more on the ODM, it is critical to ensure data structures Additional validations will be put in place at the time of CRF upload to ensure continuity in data structures

Participant Portal (post 3.1.5) Develop a stand alone application that leverages OpenClinica Study design is done in one place (OpenClinica) and deployed to both systems, including event/CRF design, skip logic, and study calendar => no separate study build process Provide a participant data entry interface and submit data back to OpenClinica instance. Provide participants the ability to complete the right forms at the right time plus provide the management tools needed to manage the patient responses.

Workflow Diagram OpenClinica Study Build Participant Portal 19 OpenClinica Study Build Participant Portal Design forms & Build Study Loads study, forms & rules Design Study Calendar 1-click deploy Secure web services Build reminders and checks

Workflow Diagram OpenClinica EDC Participant Portal 20 OpenClinica EDC Participant Portal Add participant and generate schedule Register participants Schedule & reminders Capture data Manage Data Secure web services Extract & Report

Participating in the community We would love to hear your thoughts and ideas about what is in the roadmap. We want to reach out to the community and would love participation. Would you like to participate in working groups for new features? Would you like to make contributions of code, etc? Questions / Comments?