Obtaining protocol approvals for research conducted on human subjects is a critical first step for many research studies and trials. The process is deadline driven, time consuming and complicated. Each project must go through IRB (Institutional Review Board) review and guarantee protection of the human research subjects. The review 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 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 member’s to collaborate and stay informed of each other’s progress, as well as be notified of approaching deadlines. The 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 protocol application is approved for research compliance you can use Key Solution’s modules for Research Administration including Grants Management and Conflict of Interest and Clinical Trial Management.

Key Highlights:

• Online submission, including an automatic check for completeness
• Controlled and secure user access
• Access to review status, as well as reviewer comments and feedback
• Side-by-side changes displayed for version control
• Email notification to users requiring action steps
• Email messaging between investigator, IRB and reviewers
• Ability to set up meetings with panel members and record minutes
• Ability to generate standard and custom reports in PDF, HTML or Excel format
• Encrypted signatures for use with Approval Letters and other documents
• Ability for revision, renewal, and reporting adverse events
• Closed protocols archived for later use or revision