Key Solutions Product

IRB Software for Human Subjects Back

Satisfying IRB requirement is a critical first step for research conducted on human subjects. Key Solutions offers a module that automates the online protocol application submission, review, and approval process; eliminating risk, and maximizing efficiency.

Obtaining IRB (Institutional Review Board) protocol approvals for research conducted on human subjects is a critical first step for many research studies and trials. The IRB process is deadline driven, time consuming and complicated. Each project must go through IRB review and guarantee protection of the human research subjects.

The IRB review procedures and policies governing the ethical conduct and treatment of human subjects in biomedical and behavioral research are stringent. Specific principles must apply to research regarding the need for consent, the need to minimize risk, and the requirement that subjects be selected fairly. Research protocol must demonstrate a process for implementing the policies and determining how well the rules are being enforced.

Key Solutions offers a web-based Integrated Research Administration and Compliance module for IRB that automates the protocol application online submission, review and approval process; saving valuable time, eliminating application errors, reducing compliance risks and enhancing the protection of research subjects.

The entire IRB protocol application is created, reviewed and managed electronically, which allows everyone to be working from the same document. Each member of your team – principal investigators, research administrators, reviewers and the IRB Committee – has centralized, online access to the protocol application. An email notification system makes it easy for team members to collaborate and stay informed of each other’s progress, as well as be notified of approaching deadlines. The IRB module includes robust agenda, report and archive features. An entire history of forms, comments, attachments, notes, agenda minutes and reports is maintained for each protocol application submitted for approval. Automatic ‘Check for Completeness’ system makes sure that your IRB protocol application is complete before it is submitted.

Once your IRB protocol application is approved for research compliance you can use Key Solution’s modules for Research Administration including Grants Management, Conflict of Interest and Clinical Trial Management.

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