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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: 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.

 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

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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 Visit windows Repeating visits, conditional visits Reminders and messages Multiple calendars Schedules based on group

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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 Diagram19

Design forms & Build Study

Design Study Calendar

Build reminders and checks

OpenClinica Study Build

Participant Portal

1-click deploy

Secure web services

Loads study, forms & rules

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Workflow Diagram20

Add participant and generate schedule

Manage Data

Extract & Report

OpenClinica EDC

Participant Portal

Secure web services

Register participants

Schedule & reminders

Capture data

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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?