OpenClinica 3.3 provides a study designer (such as a Data Manager) to define a schedule of events that will automatically be scheduled. OpenClinica 3.3 also supports the use of Tokens as variables which can be used dynamically for Study entities. This means a CRF designer can use a Token to build, for example, a dynamic URL.

Click here for the complete change log.

New

FeatureDescription
Schedule Next Event Study designers can build rules to automatically schedule events using Event Start Date and Event Status. When users schedule events and perform data entry, the next event or events can be automatically scheduled.
Parameterized links

 Using Tokens (substitution variables) for study objects (such as Study Name, Event Name, CRF Name, Study Subject, etc). users can designer a form that will dynamically use the value of these variables either for representation on the form, to build a dynamic URL or for use in jquery.

Changes and Fixes

FeatureDescription
Long duration of saving CRFs with dynamic items Long save times were experienced with complex CRFs including dynamic items. Indeces were added to improve performance times.

Removed

FeatureDescription
N/A 

 

Other Links

Known Issues

Below is a list of known issues in the 3.2 version of OpenClinica.

For Developers

 

 

OpenClinica 3.3 Release Plan

1.  Purpose

The goal of this release is to complete as many Minimally Releaseable Features (MRFs) that are of high value and priority to our customers within the alotted time of the release. 

2.  Target Release Date 

The planned date for the completion of this is 2014-06-13.

The release will be divided into 3 Sprints of 2 week duration.  This release shall be date driven, rather than feature driven, so the release date shall remain static, while release content is subject to change.

3.  Development Team 

The following Scrum team will be responsible for implementing the Minimally Releaseable Features (MRFs) included in this release:

Team MemberRole
 Alicia Goodwin Product Owner 
 Chris Connor QA Manager 
 Jamuna Nyayapathi  Lead Developer 
 Joe Keremian  Developer 
 Ron Panduwana Developer 
 Stephen DiBona  Developer / Scrum Master
 James Bonica  Software Quality Engineer 
 Hiro Honshuku Software Quality Analyst


Based on previous releases and current team composition, the predicted Sprint Velocity of this team is 20 Story Points completed per Sprint.

4.  Target Environments Supported

The following is a list of environments this Release shall be supported on:

Environment NameDeploymentOSDBMSApplication ServerJava
Target Platform 1 (TP1)Optimized HostingUbuntu 12.04 LTSPostgreSQL 8.4Tomcat 7JDK 7 
Target Platform 2 (TP2)On-PremiseWindows Server 2003 R2PostgreSQL 8.4Tomcat 7JDK 7
Target Platform 3 (TP3)On-PremiseCentOS 6.5 (~RHEL 6.4)PostgreSQL 8.4Tomcat 7JDK 7

5.  Areas Under Development

The following are the Minimally Releaseable Features that will be included as part of this release, in order of priority.

    1. Schedule next event for subject based on current event: Rules can be written and executed to run against a date for the current event to schedule the next event.
    2. Parameterized Links/Tokens: The ability during CRF design for the author to create text and use predefined tokens which will dynamically substitute the desired metadata and clinical data during data entry.

Because the release is date driven, MRFs towards the bottom of the list could be pushed to the next release if they are not ready on the release date. The list will be updated on an ongoing basis to reflect any changes in priority. 

Click here for the complete list of issues tagged for the release.

6.  Release Calendar

 The following chart depicts the order and timeline in which the User Stories comprising the MRFs shall be implemented.  All Stories link back to their corresponding JIRA ticket.

Feature

Sprint 1Sprint 2Sprint 3
 Apr 11 – Apr 24Apr 25 – May 8

May 9 – May 22

Schedule Next Event1. SPIKE: Investigate rules test coverage12. Prevent event schedule update if data entry started 
2. Migrate Rules Designer code to Hg13. Update test page.  Testing for imported rules using event start date 
3. Update Rules Designer logo14. Download rule XML with support for EventOID, Status, Start Date, and Event Action. 
5. Upload and validate a rule using event startDate and Status in target expression15. Support WS RunOn modes for scheduling rules 
6. Upload and validate a rule using event startDate and Status in Event Action17. Using Rule Designer, create and validate Event startDate and Status in Target and Expression 
7. Schedule a subsequent future event automatically when a triggering event is scheduled (create)18. Using Rule Designer, create and validate Event startDate and Status in Action 
8. SPIKE: Make sure Rules Designer can handle both xsds (oc_rules_v1, oc_rules_v2)  
9. Upload and validate rule for repeating event  
10. Future event date should be updated automatically when update earlier event date (update)  
11. Schedule chained events, support repeating events  
Parameterized Links/tokens  16. SPIKE: Investigate overal design needed to support parameterized links/tokens20. Build Item Data / Data substitution tokens
  19. Build common tokens for substitutions21. Build Event / Event Repeat substitution tokens
  22. Update CRF display/render logic to substitute tokens for their actual values
  23. Update PrintCRF render logic to substitute tokens
  24. Update CRF upload/validation functionality to validate tokens in CRF fields supporting tokens
  25. Update CRF template
Bug Fixes 4. CRF data entry indexes to improve performance  

 

7.  Quality Records

The following artifacts shall be produced as part of this release for the Enterprise version of the software.

  1. Software work product.
  2. Infrastructure/environment improvements.
  3. Product documentation to be produced, such as user guides and training materials.
  4. Quality Records to be produced, including:
    1. Product Requirements and Specifications
    2. Test Reports
    3. Traceability Matrix
    4. Regulatory Risk Assessment
    5. Quality Summary Report