Welcome

1. Presented by: Alicia Goodwin Welcome

2. 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

3. 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)

4. 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

5. 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

6. 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

7. 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

8. Print Casebook

9. CRF with Data

10. Print with Discrepancy Note and Audit

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

12. Study Calendaring

13. 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>

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

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

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

17. 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

18. 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.

19. Workflow Diagram • 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

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

21. 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?