1. Presented by: Alicia Goodwin
Welcome
Presented by: Alicia Goodwin
OpenClinica Welcome

2. OpenClinica Technologies Product Roadmap What we’re doing now
What to look forward to in the future:
Participating in the community
Ideas for getting involved
Plugins around APIs
OpenClinica Welcome

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 Postgres: upgrde to 9.2
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 OpenClinica Study Build Participant Portal19
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 OpenClinica EDC Participant Portal20
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?