Drug Clinical Trial Management System is one of the series products for clinical trial designed by Haitai according to “Measures for the qualification accreditation of drug clinical trial institution” issued by China’s Food and Drug Administration. The system completely meets regulatory requirements of information management for clinical trial project, workflow management, quality management and office administration, supports the functions all around in the clinical trial projects' whole-course information that the institution's office should control.
Functions and Features
The system provides complete functional supports from establishing relationship, project initiating, implementation to completion, and conduct quality control for every parts of the whole project workflow as to improve the level of administrator's clinical trial.
In terms of contract management, the normal using type of contract can be maintained in the contract template library; user can invoke the required template of contract for project contract draft then download and print the contract.
In terms of funds management, user can directly click the relevant items when drawing up funds of trials to estimate the total costs automatically by maintaining charging detail template for each item. The related item expense can also be synchronized with the financial system of hospital.
The system can manage the earning, expenditure statement, total amount and relevant information of all items, and provides summary statements. In addition, the relevant content can be queried according to the required condition.
In terms of staff training, the system can record the detail information of internal training, dispatch training and the other type of training, containing time, place, type, participants and so on for exporting statements and all kinds of querying. All the training materials are available for users to upload, save, download and read according to different permission settings. Users are capable of knowing the training effectiveness by online answering from staffs, time and accuracy recording.
In terms of the clinical trial quality control, system workflow management tool configures different quality control solutions (Including level 1st, level 2nd and level 3rd) used for different types of project. System will automatically remind users. The relevant quality control records each time are automatically listed in the configuration templates for users to edit, download and print. By permission settings, users can get feedback of relevant quality control information. The system provides all the quality situation lists of items for users to make summary and reports. Users can use reporting tool to display the status of each project, the situation of adverse events, the time of the first inclusion in the group, etc.
• In terms of medication administration, system provides detail information management on acceptance of storage, drug leaving and returning to the warehouse as to automatically generate inventory list for the drug administrator to check the inventory. As for the detailed information record of drug dispensing, recycling and returning, the system can automatically conduct the early warning alert for the drug quantity according to the inventory and random situations. The system provides the query lists of medicine usage for users to monitor each patient's medication in the whole course, to ensure that the medicine using data is traceable and meets the calculation requirement of treatment compliance.
For the various project archives in each trial phase, the system provides the authorities for users to upload, download, and query the archive situation; for the documents of institution administration, the system provides template configuration for edit, save, query, download, and print.
According to the workflow of pilot project, the system performs its management in six stages: Establishing contacts, Preparation, Implementation, Ending, follow-on stage and Filing. By linking the project workflow node, analyzing the information of each department, combining with the process node control, the system can achieve the association of information in clinical pilot departments and various workflow nodes thus form the mechanism of mutual support and interaction to improve efficiency.
The system message engine timely reminds each user of the related items during project workflow in time via message such as project control time reminder. Besides, message engine can conduct task pushing among different roles in clinical trial interaction such as adverse events reporting for professional group, first case reporting in the group, etc. The relevant information can be conveyed to the institution administrator directly via the task pushing mechanism. This model will strengthen workflow management, and simplify the workflow.
Server: IBM AIX, Windows 2003 Server, Windows 2008 Server
Client: Windows XP/ Vista/7/8
Database: DB2 and Oracle are preferred; And it also support other data bases
Middleware: IBM Websphere 7.0 or higher