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OpenClinica 2.0.1 Released

Hello,

We have made a new version of OpenClinica available on the OpenClinica.org website. After logging in, you can view the packages here: http://www.openclinica.org/entities/entity_details.php?eid=337. The 2.0.1 release resolves many of the issues found in 2.0. In addition to the full release distributions, you will also find patch packages suitable for upgrading existing versions of 2.0. For more information about the issues addressed, please view the attached readme file.

Thank you,
Jaron

..................................
Jaron Sampson
Software Engineer, Akaza Research
One Kendall Square
Bldg. 400, 4th Fl
Cambridge, MA 02139
tel: 617.621.8585 x.15
fax: 617.621.0065
cell: 505-590-7553

--
No virus found in this outgoing message.
Checked by AVG Free Edition.
Version: 7.5.446 / Virus Database: 268.18.10/720 - Release Date: 3/12/2007 7:19 PM
README.txt
--------------------------------------------------------------
OPENCLINICA RELEASE NOTES
OpenClinica Version 2.0.1
Document Version 1.1
--------------------------------------------------------------
--------------------------------------------------------------
Updated: Mar. 01 2007 Jason Carmichael [email protected]
--------------------------------------------------------------
The OpenClinica 2.0.1 package has been compiled by JDK 5 Update 11, so there should be no issues with the early Daylight Savings Time change as long as the host system has been updated as well.
--------------------------------------------------------------
OVERVIEW
--------------------------------------------------------------
This release of OpenClinica addresses issues in OpenClinica 2.0
--------------------------------------------------------------
CONTENTS OF THIS DOCUMENT
--------------------------------------------------------------

I. OVERALL PRODUCT FEATURES
II. ISSUES ADDRESSED
III. SOFTWARE DEPENDENCIES AND SYSTEM REQUIREMENTS
IV. ABOUT OPENCLINICA
V. GNU LGPL LICENSE
--------------------------------------------------------------
I. OVERALL PRODUCT FEATURES
--------------------------------------------------------------
Overall Product Features
The main modules include:
* Submit Data: Allows subject enrollment, data submission and validation for use by clinicians and research associates.
* Extract Data: Enables data extraction and filtering of datasets for use by investigators and study directors.
* Manage Study: Facilitates creation and management of studies (protocols), sites, CRFs, users and study event definitions by study directors and coordinators.
* Business Admin/Technical Admin: Allows overall system oversight, auditing, configuration, and reporting by administrators.
Some key features of OpenClinica include:
* Organization of clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure and transparent manner.
* Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters and validation logic specified in portable Excel templates.
* Management of longitudinal data for complex and recurring patient visits.
* Data import/export tools for migration of clinical datasets in excel spreadsheets, local databases and legacy data formats.
* Extensive interfaces for data query and retrieval, across subjects, time, and clinical parameters, with dataset export in common statistical analysis formats.
* Compliance with HIPAA privacy and security guidelines including use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.
* A robust and scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including PostgreSQL (open source) and Oracle 10G, to support the needs of the clinical research enterprise.
--------------------------------------------------------------
II. ISSUES ADDRESSED
--------------------------------------------------------------
All issues listed can be found at http://www.openclinica.org/bugtracker, please enter the corresponding issue ID number to review details and fixes. This patch fixes the following bugs for OpenClinica-2.0.1.zip from OpenClinica.org download site:
0000920: Linux install guide fixes
0000923: Default datainfo.properties file content
0000915: System emails from multiple instances going to "openclinica-admin"
0000928: OpenClinica 2.0 beta - install scripts missing
0000929: Tomcat on Linux: Developers group assumed but not present on default
0000930: Specified tomcat version not available
0000961: Provide explanation of \"Person ID\" field
0000969: No email for default account 'root
0000968: Error sending the user an email regarding the user's new password when restoring 'testuser'
0000931: Edit subject record - Changing person id does not enforce uniqueness check
0000954: \"Create a New CRF Version\" Workflow is confusing
0000955: After CRF Upload, too many clicks required to view it
0000957: Need \"Go Back to CRF List\" link on ViewTableOfContents page
0000981: Printing multi page CRFs should print pages in correct sequence
0000956: Stray commas in CRF Version Metadata Response Options column
0000924: The data warehouse utilities for windows not included in distro
0000916: Baseline data for subject_event_status table is missing
0001017: Discrepancy Manager - don't show 'Resolve' icon if user is not allowed to resolve the item
0000995: Remove or Replace Tomcat's "favicon" on Live Demo
0001019: Database Cleanup: Remove used tables from database schema
0000994: Cron job from data warehouse fails
0001054: Study Sites not inheriting event definition information from parent
0000911: Alerts and Messages task pane should be closed if there is no message. Alert text should use the 'alert' class.
0000990: Need to update help redirect files to point to 2.0 online help guide. Need to deploy 2.0 help guide to OpenClinica.org.
0000996: Task Pane on Login page needs padding on left
0001028: View Subject Matrix Drop Down Menu Misalignment - Internet Explorer
0001012: View Subject page, View/Edit Event page should show View/Print options for all CRFs, even not started ones
0000849: CRF Design upload errors on INSERT statement
0001047: FIND button has CONTINUE button behavior
0001001: Printable Event CRF does not display Event name correctly in header
0000788: Glossary of terms needs to be fleshed out, contains smart **** comments, etc.
0001141: Update linux and Windows install guides with contents of new datainfo.properties file
0001142: Account creation email has no link to login page and no line breaks
0001143: Textarea field in CRF appears as regular single line textbox
0001132: Disable popup blockers
0000589: Locking Event Condition
0001135: System emails need additional information
0000567: Missing help section
0001122: Database Initialization Scripts [Was ERROR: role "clinica" does not exist]
0001133: Manage Study Audit logs page do not seem to show Study, Subject, or CRF audit activity
0001134: View Subject Recent Activity Log does not allow access to full activity report for this study subject.
0001140: Metadata definition links in Discrepancy Note details window are broken.
0001139: Adding an existing version of a CRF fails when new items are added to the new version.
0000721: Describe DDE wrt discrepancy notes
0000816: Installing PostgreSQL on Redhat
0000521: Problem with showing red icon for deleting crfs
0000435: Enroll Subject allows you to enter a birth date in the future (1/1/2006)
0001067: When submitting an Event CRF and a validation check fires, interviewer name and interview date do not persist
0001068: CRF Section tabs do not 'focus' on current tab
0001130: Add a new subject page cannot show box of Gender even if 'genderRequired' = yes when viewing the study parameters
0001131: Refine the basecase sql to create a default study
0000993: Manage Groups displayed in reverse of submitted order
0001160: Add a subject using the quick 'Add a subject' mechanism should bring user to the 'View Subject' page upon success
0001164: 2.0 install guide (windows) - there are two versions of the document in the distribution
0001165: Install guide does not mention how to set up blank CRF template to be downloadable by OpenClinica
0001150: CDISC ODM MetaData is for the whole CRF which might be different from ClinicaData
0001151: Convert between OpenClinica Date (MM/DD/YYYY) and CDSIC ODM Date (YYYY-MM-DD) datatype
0001152: Mapping attribute "Name" of ODM Metadata element ItemDef
0001153: The criterion for ItemGroupRef - Mandatory
0001156: StudyDescription is description of the Current Study
0001070: SASDatasetName duplicated in one file
0001088: Add changing port instructions to Installation Guides
0001033: Revise web copy on Create New Study - Section F entry screen
0001167: Double Data Entry does not flag difference in checkbox data entry
0001145: "costly sequential scans" warnings during database installation
0001083: CRF Excel Spreadsheet - no spaces, slashes, etc. allowed in "Item Name" field
0001084: CRF Excel Spreadsheet - PHI is a required field
0001120: "Unspecified Error" screen appears when Keyword Search returns no results
0001121: Removed studies are still the user's "Active Study"
0001110: Sorting columns in subject matrix
0001124: Inline add subject interface does not align correctly
0001125: Date validation failing when adding a subject with existing person id
0001161: Request Password Form
0000608: Help Guide: Use of Nulls
0001147: SPSS extract data bugs
0001163: Tooltip missing for View Event button on Manage All Subjects
0000671: Limit Inputs, check for html metadata & entities
0001146: Type mismatch warnings during database installation
0001197: After uploading and validating an Excel file, CreateCRFVersionServlet throws an exception when the user clicks associated button
0001203: Clarification is needed for documenting "Create data folders"
0001186: Calendar has faulty Z-order
0001206: Auto-generated study subject id's do not work
0001216: Multiple modification for "add new subject"
0001207: When adding a study subject and linking to a global subject - numerous errors
--------------------------------------------------------------
III. SOFTWARE DEPENDENCIES AND SYSTEM REQUIREMENTS
--------------------------------------------------------------
Pre-requisites (versions):
Operating system(s): Windows XP, Windows Server 2003, Redhat Enterprise Linux 4.0+
Browsers: Internet Explorer 6.0+, Mozilla Firefox 1.5+
JDK : 1.5.0_10
Application server : Tomcat 5.5.20
Database server : PostgreSQL 8.1.6
OpenClinica version : OpenClinica 2.0.1
NOTE: You must configure the smtp host correctly, or the system will hang when trying to send email notifications. If you don't want to use outgoing mail features, a workaround would be to set this value to a mail server with a short timeout. If you are running Tomcat 5.5.17, please upgrade to 5.5.20. This has been noted a a Known Issue and will be resolved in a future release.
--------------------------------------------------------------
IV. ABOUT OPENCLINICA
--------------------------------------------------------------
OpenClinica: Open Source Software Platform for Managing Clinical Research Studies
Professional Open Source Solutions for the Clinical Research Enterprise
OpenClinica is a software platform for protocol configuration, design
of Case Report Forms (CRFs), and electronic data capture, retrieval,
and management. It is extensible, modular, standards-based, and open source.
More about OpenClinica: http://www.OpenClinica.org
Software License
OpenClinica is distributed under the GNU Lesser General Public License (GNU LGPL).
For details see: http://www.openclinica.org/license or LICENSE.txt distributed with this distribution.
Developer and Contact Information
Akaza Research, based in Cambridge, MA, provides open informatics solutions
that address the needs of academic and non-profit institutions engaged in
clinical, healthcare and biomedical research.
Akaza utilizes internally- and community-developed open source software and
open standards to provide professional services for the clinical research enterprise. These open solutions enable Akaza's customers to effectively address the challenges
of data management, compliance, and interoperability in the modern clinical and
healthcare research environment.
Akaza Research
One Kendall Square
Bldg. 400, 4th Floor
Cambridge, MA 02139
phone: 617.621.8585
fax: 617.621.0065
email: [email protected]
For more about Akaza's products and initiatives see:
http://www.akazaresearch.com/
http://www.OpenClinica.org/
--------------------------------------------------------------
V. GNU LGPL LICENSE
--------------------------------------------------------------
OpenClinica is distributed under the GNU Lesser General Public License (GNU LGPL),
summarized in the Creative Commons text here:
http://creativecommons.org/licenses/LGPL/2.1/
The GNU Lesser General Public License is a Free Software license. Like any Free Software
license, it grants to you the four following freedoms:
0. The freedom to run the program for any purpose.
1. The freedom to study how the program works and adapt it to your needs.
2. The freedom to redistribute copies so you can help your neighbor.
3. The freedom to improve the program and release your improvements to the public, so
that the whole community benefits.
You may exercise the freedoms specified here provided that you comply with the express conditions of this license. The LGPL is intended for software libraries, rather than executable programs.
The principal conditions are:
* You must conspicuously and appropriately publish on each copy distributed an appropriate copyright notice and disclaimer of warranty and keep intact all the notices that refer to this License and to the absence of any warranty; and give any other recipients of the Program a copy of the GNU Lesser General Public License along with the Program. Any translation of the GNU Lesser General Public License must be accompanied by the GNU Lesser General Public License.
* If you modify your copy or copies of the library or any portion of it, you may distribute the resulting library provided you do so under the GNU Lesser General Public License. However, programs that link to the library may be licensed under terms of your choice, so long as the library itself can be changed. Any translation of the GNU Lesser General Public License must be accompanied by the GNU Lesser General Public License.
* If you copy or distribute the library, you must accompany it with the complete corresponding machine-readable source code or with a written offer, valid for at least three years, to furnish the complete corresponding machine-readable source code. You need not provide source code to programs which link to the library.
Any of these conditions can be waived if you get permission from the copyright holder.
Your fair use and other rights are in no way affected by the above.
Full GNU LGPL License text:
http://www.gnu.org/copyleft/lesser.html
Attachments:
README.txt 14.5 KB

Comments

  • nettonetto Posts: 1
    Hello,
    Please send my login name and password.
    Thanks,
    Joaquim T. Netto
    > > Hello,
    > >
    > >
    > >
    > > We have made a new version of OpenClinica available on the
    > > OpenClinica.org website. After logging in, you can view the packages
    > > here: HYPERLINK
    > > "http://www.openclinica.org/entities/entity_details.php?eid=337"http://www.openclinica.org/entities/entity_details.php?eid=337.
    > > The 2.0.1 release resolves many of the issues found in 2.0. In addition
    > > to the full release distributions, you will also find patch packages
    > > suitable for upgrading existing versions of 2.0. For more information
    > > about the issues addressed, please view the attached readme file.
    > >
    > >
    > >
    > > Thank you,
    > > Jaron
    > >
    > >
    > >
    > > ..................................
    > >
    > > Jaron Sampson
    > >
    > > HYPERLINK "http://akazaresearch.com/"Software Engineer, Akaza Research
    > >
    > > One Kendall Square
    > >
    > > Bldg. 400, 4th Fl
    > >
    > > Cambridge, MA 02139
    > >
    > > tel: 617.621.8585 x.15
    > >
    > > fax: 617.621.0065
    > >
    > > cell: 505-590-7553
    > >
    > >
    > >
    > >
    > > --
    > > No virus found in this outgoing message.
    > > Checked by AVG Free Edition.
    > > Version: 7.5.446 / Virus Database: 268.18.10/720 - Release Date: 3/12/2007
    > > 7:19 PM
    > >
    > >
    > >
  • As you may know, users need to set up an account in openclinica.org to
    download OpenClinica products and interact with other members of the
    OpenClinica community.
    If you do not have such an account yet, please go to
    http://www.openclinica.org/
    Follow the link "Request an Account" in the panel on the left side and
    fill request account forms, you will have your account set up
    automatically.
    There is also "Forget Password" link there.
    You may change your password once you login.
    Let us know if more help needed.
    Thanks,
    Yufang Wang
    -----Original Message-----
    [mailto:[email protected]] On Behalf Of vendas
    Sent: Wednesday, March 14, 2007 7:41 AM
    To: [email protected]
    Subject: Re: [Developers] OpenClinica 2.0.1 Released
    Hello,
    Please send my login name and password.
    Thanks,
    Joaquim T. Netto
    > > Hello,
    > >
    > >
    > >
    > > We have made a new version of OpenClinica available on the
    > > OpenClinica.org website. After logging in, you can view the packages
    > > here: HYPERLINK
    > >
    "http://www.openclinica.org/entities/entity_details.php?eid=337"http://w
    ww.openclinica.org/entities/entity_details.php?eid=337.
    > > The 2.0.1 release resolves many of the issues found in 2.0. In
    addition
    > > to the full release distributions, you will also find patch packages
    > > suitable for upgrading existing versions of 2.0. For more information
    > > about the issues addressed, please view the attached readme file.
    > >
    > >
    > >
    > > Thank you,
    > > Jaron
    > >
    > >
    > >
    > > ..................................
    > >
    > > Jaron Sampson
    > >
    > > HYPERLINK "http://akazaresearch.com/"Software Engineer, Akaza Research
    > >
    > > One Kendall Square
    > >
    > > Bldg. 400, 4th Fl
    > >
    > > Cambridge, MA 02139
    > >
    > > tel: 617.621.8585 x.15
    > >
    > > fax: 617.621.0065
    > >
    > > cell: 505-590-7553
    > >
    > >
    > >
    > >
    > > --
    > > No virus found in this outgoing message.
    > > Checked by AVG Free Edition.
    > > Version: 7.5.446 / Virus Database: 268.18.10/720 - Release Date:
    3/12/2007
    > > 7:19 PM
    > >
    > >
    > >
This discussion has been closed.