Page 31 - eBook Version 8 Book 1 of 2 JUL 2022

Children’s Health Research Protocol Feasibility Checklist
I. Protocol/Regulatory
Protocol Title
Principal Investigator (PI) Name
Research Coordinator Name
1. Are there any known competing approved studies ongoing at Children’s Health?
2. Is this study similar to previous studies conducted at Children’s Health?
Yes
No
• If yes – will there be sufficient eligible patients to complete this study?
Yes
No*
Yes
No
• If yes – were the previous studies successfully completed?
Yes
No*
3. Is this study funded by an external sponsor?
Yes
No
• If yes – was the previous study completed successfully/was the previous experience satisfactory?
Yes
No*
• If yes – will the sponsor be paying for participants who fail screening procedures OR is the institution will to subsidize screen failures?
Yes
No*
4. Are there any anticipated Institutional Review Board (IRB) or Performance Site Approval (PSA) related issues?
Yes
No
• If yes – will these anticipated issues allow for enough time to recruit participants to complete the study?
Yes
No*
5. Is the study designed in an ethical and scientifically-appropriate manner?
Yes
No*
6. Do the potential benefits to study participants outweight the anticipated risks?
Yes
No
• If no – is the study likely to produce generalizable knowledge about a particular disorder or condition?
Yes
No*
7. Is the study visit schedule practical for study personnel and potential participants?
Yes
No*
8. Will the study require external application, review, and approval (e.g., FDA IND) to conduct the study?
Yes
No
• If yes – are Children’s Health, the PI, and all appropriate parties prepared to meet the regulatory burden and legal liability for such application approval?
Yes
No*
9. Are frequent and/or severe unanticipated problems anticipated?
Yes
No
Version 06/22/2017