How new technologies in the OpenClinica product roadmap may be

Presented by: Alicia Goodwin
 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 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!
 Print CRF
 Expanded browser support
 These are the building blocks for the next generation of
 Enhancements to ODM
 RESTFul architecture
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
 Assignment of study roles and user privileges within
 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
 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:
<!-- The target is Study events target date, So i want to trigger this when this start date changes. i.e the event is
<!-The Study Subject object and it's property.
How do we refer to the propert names ?? enrollmentDate
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"
<DestinationProperty Value="" OID="SE_TREATMENTVISIT2.dateStarted">
<ValueExpression>SE_TREATMENTVISIT1.dateStarted + 4</ValueExpression>
<DestinationProperty Value="scheduled" OID="SE_TREATMENTVISIT1.subjectEventStatus"/>
 Let’s have a look at “Jikan”…
Stack upgrade
 Tomcat: upgrade to 7
 Overall performance improvements
 Postgres: upgrde to 9.2
Enhancements and fixes to Rules
 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
 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
 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
Study Build
Participant Portal
Design forms &
Build Study
Design Study
Build reminders
and checks
Loads study,
forms & rules
1-click deploy
Secure web
Workflow Diagram
Add participant and
generate schedule
Register participants
Schedule & reminders
Capture data
Manage Data
Extract & Report
Secure web
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
 Would you like to participate in working groups for new
 Would you like to make contributions of code, etc?
 Questions / Comments?