Welcome
Presented by: Alicia Goodwin
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 OpenClinica Technologies
 Product Roadmap
 What we’re doing now
 What to look forward to in the future:
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https://docs.openclinica.com/release-notes
 Participating in the community
 Ideas for getting involved
 Plugins around APIs
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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)
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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
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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.
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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
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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
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Print Casebook
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CRF with Data
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Print with Discrepancy Note and Audit
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Study Calendaring
 New calendaring functionality
 Advanced calendar functionality
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Visit windows
Repeating visits, conditional visits
Reminders and messages
Multiple calendars
Schedules based on group
Study Calendaring
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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>
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Calendaring
 Let’s have a look at “Jikan”…
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Stack upgrade
 Tomcat: upgrade to 7
 Overall performance improvements
 Postgres: upgrde to 9.2
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Enhancements and fixes to Rules
engine
 Expose additional variables (e.g. Dates)
 Fixes around relative vs. absolute paths
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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
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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.
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Workflow Diagram
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OpenClinica
Study Build
Participant Portal
Design forms &
Build Study
Design Study
Calendar
Build reminders
and checks
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Loads study,
forms & rules
1-click deploy
Secure web
services
Workflow Diagram
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OpenClinica
EDC
Participant
Portal
Add participant and
generate schedule
Register participants
Schedule & reminders
Capture data
Manage Data
Extract & Report
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Secure web
services
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?
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