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Electronic Clinical Trial System Development with SharePointThe Client The client is a clinical healthcare provider from US, who focuses on providing various medical care services nationwide. What the Client Wanted There had already existed a system performed as information central that offered access to all appropriate clinical information for a given set of users. The system which was based on Microsoft SharePoint Service technologies enabled healthcare practitioners to get timely information and make decisions for the patients, so largely improved the efficiency of communication and collaboration. Prior to production, there was still a lot of development work needed to be done, thus, the client turned to Abstract Technology to fulfil the development work. The work included audit trails functionality, workflow features, data validation, data analyse and reports, and furthermore some web parts development tasks that provided new functionalities to enhance the original system. Most of the work must comply with the 21 Code of Federal Regulations 11 compliance (21 CFR Part 11) of U.S. Food and Drug Administration (FDA). The Solution Abstract Technology's veteran SharePoint engineers firstly anatomised the original system including the functionalities and framework. Depending on our engineers' good understanding on the object models of SharePoint as well as InfoPath, and through the effective communication with the client and quickly learning of FDA documents. Abstract Technology well understood the whole structure of the system and the detailed requirements in a short time. Subsequently, Abstract Technology quickly set up a development team. The detailed requirement specification and project plan were provided to client. In order to make client well track Abstract Technology's work progress, the daily and weekly work reports were sent to the client. Audit Trial function, which required any change to data stored on electronic media, is a basic requirement in the data process; the engineers developed a SharePoint document library event handler assembly to capture any event that the InfoPath library raised. Basing on the great XML processing ability, the engineers worked out the function that could help to find any change (add, update, delete) to the InfoPath form, then any change to the InfoPath form would be saved into the database. Audit trail web parts on the SharePoint site displayed the data, so the search, ordering etc were added into the web part. In the next version, SharePoint would support workflow feature such as the authentication of InfoPath reports' access and actions, automatic email notification etc. By utilizing current version (Microsoft SharePoint Portal Server 2003) we had built our own workflow and added it into the SPS site. After evaluating the workflow engines like Microsoft BizTalk 2004, Skelta Accelerator 2004 (www.skelta.com) and so on, Abstract Technology decided to develop our own workflow engine to realize the workflow features so as to save much development cost for the client. The InfoPath form XML data, taken as the data source when generating reports, was requested to be saved into database, so was the clinical data that must be consistent with the clinical research and clinical care database. We developed some XML web services to analyse and aggregate these data into database. With regard to the clinical trial data and report, Abstract Technology used Microsoft Report Services and Data Transfer Services as the data report platform and displayed information in the report service web parts and third parties tools like DSPanel ( www.dspanel.com ), which proved very effective and efficient. InfoPath development included automatically locking and freezing some fields of an IP form or the whole form, automatically getting data from the SPS site lists as well as data validation. Our skilled engineers in InfoPath added rules/data validation into the InfoPath template and wrote necessary Jscript code to realize to lock/unlock function, also the web service to get data. In addition, Abstract Technology developed some web parts that provided new functionalities to enhance the original system. The "Enrol site" web part we developed was used to let users be able to create a new sub site for the current site. Users could select available sub site templates available from dropdown to create sub sites. The "Push documents" web part was used to push documents from the parent site to sub site. In this part, we suggested the client to adopt the tree structure to show the site's organization hence let users be able to select multiple documents and sub sites at a time to operate, which was very convenient for users. Users could select library, folder and document to push to sub site. Environment OS: Window Server 2003 The Benefits
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