The system is designed based on ICH GCP protocol, the Operational Guidelines for Ethics Committees that review biomedical research issued by WHO/TDR and WHO SIDCER-certified operational specification of ethical committee to realize the electronization of procedures of ethical review including application, acceptance, review, conveying decisions and follow-up review as well as managing ethical review information in compliance to standard ethical review procedures.
Functions and Features
The workflow of the system is set up in strict compliance with workflow standards of ethical committee. It provides functional support for ethical review work in each phase including ethical review application, acceptance of application, the processing of application, convening a review meeting, conveying decisions and documentation. At the time when the project is initially created, the system will automatically select the corresponding review process and document templates based on the type of the project and the review.
For all related documents in all phases of ethical review such as application document, review charts of all review types, review decision document, minutes of the meeting and etc, the templates can be generated automatically in light of the type of the project and the review. All the documents of the project including electronic documents to be reviewed and those generated in the process can be saved automatically and viewed, downloaded by authorized users.
Adopt node-control of ethical review processes that are irreversible, realize sharing relevant node information and form a mechanism that features mutual support and restraint. Files and documents are managed according to the type of the project and the review. Task push mechanism provides constant notifications of work in the processes. In addition, powerful reporting tools are provided for information inquiry and creating all kinds of work statements based on the review status of the project, which provides complete and detailed information for IRB office to better manage the projects being reviewed.
System message engine timely reminds users of relevant affairs in ethical review processes, such as notification of validity period of approval letters, follow-up review alerts and etc. Message engines also push messages of interacting work between different roles in ethical review, which strengthens ethical review workflow management and simplifies work processes.
Provide unified ethical review platform and carry out batch management of the project during each phase of ethical review-project acceptance, project processing, project review, conveying the decision, archiving project documents so as to enhance project management efficiency.