Conducting clinical trial feasibility is frequently one of the first steps undertaken when preparing for a study. iRIS offers the tools to simplify the process by helping users navigate through the entire study application process, from feasibility to approval.
The system is built on best practice form sets that have been developed in collaboration with large and small institutions. These forms can be used out of the box to save configuration time; or they can be tailored to institutions requirements. Our Forms Designer allows for smart form development that include functions for show/hide of sections and questions, questions validations, branching logic to skip sections and questions that are not applicable, Online Help Text, and PDF print friendly to merge web forms direct to PDF. These functions streamline the process to aid the covered person in filling out forms for submission creating, quality submissions for the QA office to review.
Feasibility also possesses a workflow of form navigation through the system. This includes defining the review process for risk scores, sending automatic email alerts to remind personnel to revisit studies under high risk, and setting up rules to monitor risk and trigger possible audit condition matches.
- Detail all resources needed in the study, including budget, overhead, subjects, drugs and devices, and timelines
- Obtain an overall projected view of trial completion, in terms of timelines, targets, and cost
- Route documents internally to your study team for review
- Electronically submit clinical trial feasibility proposals to the Feasibility Board for approval
- Lock studies until the feasibility proposal has been submitted to the board
- Utilize clinical trial feasibility software to identify study resources needed for evaluation
- Draft budgets, including any sponsor-provided overheads
- Determine subject recruitment potential, per month and throughout the entire trial