OPENCLINICA BETA RELEASE NOTES Release Version ------------------------------------------------------ OpenClinica: Open Source Software Platform for Managing Clinical Research Studies Product Version: Beta Preview Release v0.9.0 Release Date: March 24, 2005 Akaza Research, Cambridge, MA Contents ------------------------------------------------------ 1.0 About OpenClinica 2.0 Release History 3.0 Software Dependencies 4.0 Compatability and System Requirements 5.0 New Features in this Release 6.0 Bugs Fixed in this Release 7.0 Known Issues in this Release 8.0 Overall Product Features 9.0 Developer and Contact Information 10.0 GNU LGPL Creative Commons License 1.0 About OpenClinica ------------------------------------------------------ Professional Open Source Solutions for the Clinical Research Enterprise OpenClinica is a web-based software platform developed by Akaza Research for managing multi-site clinical research studies. It facilitates protocol configuration, design of case report forms, electronic data capture, retrieval, and management. OpenClinica supports HIPAA guidelines, and is designed as a standards-based extensible, modular, and open source platform. OpenClinica is targeted for use in investigator-initiated and publicly sponsored trials and observational studies. The development of OpenClinica is funded in part by grants from the National Institutes of Health (NIH) and Akaza's professional consulting work in academic biomedical informatics. OpenClincia Product Portal: http://www.OpenClinica.org Online demo of OpenClinica: http://www.openclinica.org/page.php?pid=112 Software Downloads, Install Guide and Resources: http://www.openclinica.org/page.php?pid=40 OpenClinica is distributed under the GNU Lesser General Public License (GNU LGPL). A summary of the license text is also included at the end of this release note. OpenClinica GNU LGPL License: http://www.OpenClinica.org/license 2.0 Release History ------------------------------------------------------ OpenClinica Version 0.9.0 -- March 24, 2005 OpenClinica Version 0.8.9 -- February 25, 2005 3.0 Software Dependencies ------------------------------------------------------ OpenClinica runs on top of any Servlet/JSP container that implements the Servlet 2.4 and JavaServer Pages 2.0 specifications from the Java Community Process. It was developed to run on Apache Jakarta Tomcat 5.0. Required: Jakarta Tomcat 5 Java 2 SDK 1.4.2 JavaServer Pages Standard Tag Library 1.0 Jakarta POI - Java API To Access Microsoft Format Files Jakarta Digester - XML to Java Object Configuration Postgres 8.0.1 Postgres JDBC Driver Version 8.0-310 JDBC 3 4.0 Compatability and System Requirements ------------------------------------------------------ Apache Jakarta Tomcat Servlet/JSP container. Tomcat version 5 implements the Servlet 2.4 and JavaServer Pages 2.0 specifications from the Java Community Process, and includes many additional features that make it a useful platform for developing and deploying web applications and web services. System Requirements Server Operating Systems Redhat Enterprise Linux 3.0+ Client Browser/OS Requirements Internet Explorer 5.5+ Mozilla Firefox 1.0+ Microsoft Windows 2000\256 Service Pack 4+ Microsoft Windows XP\256 Service Pack 1+ Hardware Requirements Memory: 256 MB minimum (1 GB Recommended) Disk Space: 500 MB minimum (1 GB Recommended) 5.0 New Features in this Release ------------------------------------------------------ * Submit Data - users can no longer mark an event CRF complete if the interviewer name is blank. - After Add New Subject, the message display uses the study subject label, rather than the subject unique identifier, to describe the subject just created. - In Add New Study Event, the Study Events in the drop down list are now ordered by the Study Event ordinal field. - Buttons to get from the View Study Subject screen to the Study Event Overview screen, and vice versa, have been added. There is also a button to get from the Event CRF Overview screen to the Study Event Overview screen. - The system provides defaults for location when creating study event and default interview date when entering data - In the View Study Subject and Study Event Overview screens, if the user cannot perform any kind of data entry on an Event CRF, the user sees a magnifying glass icon, rather than a data entry icon; clicking that icon allows the user to view the data in the event CRF. * Manage Study - It is now possible to preview/print CRF immediately after uploading a new CRF - It is now possible to view/print event CRF with data entered - Allows a study to collect only year of birth vs. date of birth - Allows study director to edit a study event definition after data is already entered by using the definition - Allows study director to order Event Definition and CRFs in event definition by ordinal - Group related questions into a single line for CRF data entry using COLUMN_NUMBER field in excel template * System-wide Issues and Core Classes - Allow default ordering by a selected field in the show table class 6.0 Bugs Fixed in this Release ------------------------------------------------------ * Login - Fixed bug of wrong last visit date in welcome message - Fixed bug of system crash if refresh page after submitting profile * Submit Data - Double data entry has been tested and appears to be working as expected. - The Data Entry Stage name is used to indicate the event CRF's completion status on both the View Study Subject and Study Event Overview screens. - Fixed bug related to reading data in the database for checkbox items when displaying an Event CRF section. - Changed datamodel and code so that child studies can inherit study event definitions from parent studies. - The workflow diagrams at the top of the screen now indicate which step the user is currently executing. * Extract Data - The tab-delimited and comma-delimited files both appear as text for the IE and Mozilla browsers. * Manage Study - MANAGE_STUDY Page object's URL property fixed. - Fixed bug to allow removing CRF from Event Definition - Fixed bug to remove deleted CRFs from being shown in the list of CRFs for study event definitions - Fixed bug to not require options for text field in Excel templates when uploading CRFs - Allows completion date to be optional when creating a new study - Clarifed events and status indicators in view study subject page * Administer System - Creation of new study works even if summary field is longer than 255, and added length validation - Blank date is replaced with today's date during date validation in creating a top-level study 7.0 Known Issues in this Release ------------------------------------------------------ * Submit Data - Many screens lack useful side-panel information; this will be revised in next release. - Administrative Editing has not been implemented. - Decision Conditions have not been implemented. * Manage Study - Study groups have not been implemented. * Extract classes - Extracting data depends on a view which has to be refreshed either by a cron job or by hand. Code to run the cron job automatically will be created in an upcoming release. - The ability to restore datasets and filters does not exist yet, but will soon be added. - For subjects which belong to a child study, only the child study's unique identifier is displayed in the data, not the parent study's site. - The feature which prevents filtering subjects by date of enrollment actually does impose a filter; subjects must be enrolled between Jan. 1, 1900, and Dec. 31, 2100, - File information at the Export Data stage of the process is not shown; this is in part due to a permissions issue which will be corrected. * Administer System - Auditing triggers are still being tested to make sure they do not interrupt service. * System-wide Issues and Core Classes - Breadcrumbs often rely on an assumed trail of prior breadcrumbs which do not exist. For example, if you login and immediate go to some data entry URL (by hunting through history, e.g.), you'll see a breadcrumb trail similar to "Home > Data Entry" or possibly "Home > Update Profile > Data Entry". - If a page is shared by different modules, the system cannot generate different breadcrumbs according to different user role. - Side-panel class is used in both request and session, should be in session only. Should allow setting up session wide panel info in each servelet. 8.0 Overall Product Features ------------------------------------------------------ The Main Modules include: 1. Submit Data: Allows subject enrollment, data submission and validation for use by clinicians and research associates. 2. Extract Data: Enables data extraction and filtering of datasets for use by investigators and study directors. 3. Manage Study: Facilitates creation and management of studies (protocols), sites, CRFs, users and study event definitions by study directors and coordinators. 4. Administer System: 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. More details on OpenClincia: http://www.OpenClinica.org 9.0 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 and consulting. These open solutions enable Akaza's academic 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: contact@akazaresearch.com For more about Akaza's products and initiatives see: http://www.akazaresearch.com 10.0 GNU LGPL Creative Commons 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 ------------------------------------------------------