Posted on February 28, 2008 by kkrumlian
First, here’s a quick summary of caBIG. caBIG is an NCI sponsored initiative which makes essential tools and data accessible to the cancer research community worldwide. The infrastructure developed by caBIG primarily enables the collecting, analyzing, integrating, and disseminating information associated with cancer research and care. This cutting-edge technology will help scientists and practitioners develop find better means for cancer prevention and treatment.
caBIG has already developed a wide variety of tools. These tools include various software tools, database technologies, and Web-based applications. One of these web applications that is currently under development is caAERS. caAERS is an open source web application designed to collect, process, and report adverse events that occur during clinical trials. This web application takes a rule-based approach to decide whether any particular adverse events needs expedited reporting. Once the decision has been made caAERS makes it a priority to show the user the required data needed for each report that will be sent. You can learn more about the features of caAERS by visiting it’s home page .
So what might key integration points of the OpenClinica EDC system and caAERS be? For this integration to be possible, caAERS needs to be supplied with three things:
- Study data
- Subject data
- Adverse Event data
OpenClinica facilitates configuration and management of studies and research subjects, covering our first two data requirements. OpenClinica can also be used to collect Adverse Event data during patient visits. So how could this data collected in OpenClinica be transferred to caAERS, especially since caAERS might replicate some of the data fields?
The OpenClinicaEDC platform provides an innovative and direct approach for defining Case Report Form data elements via a structured spreadsheet template. Using this approach, we can design a CRF that includes all the data elements needed by caAERSand collect this data in OpenClinica, meeting caAERS’ third data requirement. During the course of the study, we can transfer the data between OpenClinica and caAERS using the export and import tools already provided by both systems.
The approach described above is one way of integration. Since both systems are open source, modules could also certainly be added to either OpenClinica or caAERS to provide real-time integration between both systems.
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Posted on February 19, 2008 by paulgalvin
Many people who work with EDC systems have heard of or been impacted by CDISC, Clinical Data Interchange Standards Consortium. CDISC’s mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. They have many different initiatives, but one of their newest ones promises to aid the development and use of electronic Case Report Forms (eCRFs), the foundation of an EDC system.
Clinical Data Acquisition Standards Harmonization, (CDASH) aims to standardize ways of collecting data in a clinical trial. The current EDC landscape has hundreds, even thousands, of different eCRFs that capture essentially the same information, but with CDASH’s initiative one common data element can be used for each piece of information collected.
The initiative is not being pushed to enforce the way an eCRF looks and feels; rather, it seeks to standardize the way the fields and data on a form map to a database. Allowing users to create eCRFs with one standard in mind will allow the users to re-use their work again and again rather than having to create new eCRFs the next time they begin a study.
By mapping OpenClinica CRFs to CDASH content standards (element name, definition, and the related metadata) users of OpenClinica can access a basic set of global data collection fields with semantics agreed upon by representatives from Contract Research Organizations (CROs), Academia, Government and Industry. These CRFs can be found in the OpenClinica Enterprise CRF Library.
Filed under: Standards | Tagged: CDASH, CDISC, clinical research, clinical trials, CRF Library, eCRFs, EDC, OpenClinica | Leave a Comment »
Posted on February 6, 2008 by thickerson
Recently, the company Clinical Ink announced their upcoming software release. Using tablet PCs with proprietary software, they will allow EDC to take place on digital tablets “that retain the look and feel of traditional paper data collection forms.” This sounds familiar, as we’ve been working on the same thing with our CRF templates to load form metadata into OpenClinica.
Also recently, George Laszlo blogged about the Nextrials Prism system, as seen through the Apple iPhone. Boston-based PHT is porting their patient diary software to the Samsung Ultra Mobile PC.
The thing about portability is that it’s not just a closed-sourced game; Apple is releasing their SDK for developers to work on their own apps for the iPhone. Google is in the process of hyping their Android project together with the Open Handset Alliance, which is an open and free mobile platform.
In short, OpenClinica has several options for becoming a portable competitor to the above; since it runs in Java, its “write once run anywhere” architecture allows it to run on different OSes. Since it runs through a web browser, users can already set it up to run through a handheld PC running a web browser. In the future, the challenge to OpenClinica will be to evaluate the open SDKs and determine if there’s room to create a slimmed-down interface suitable for the smaller screens and simpler interfaces of the portable workforce.
Filed under: Uncategorized | Tagged: clinical ink, clinical research, EDC, health informatics, open source, OpenClinica, patient diary | Leave a Comment »