Page 32 - eBook Version 8 Book 1 of 2 JUL 2022

• If yes – are Children’s Health, the PI, and all appropriate parties prepared to devote resources to care for affected research participants and assume the liability for the study?
Yes
No*
* If a “No” with an asterisk is checked above, this study may not be feasible to conduct and complete at Children’s Health.
II. Participant Recruitment and Enrollment
1. Does Children’s Health have enough potential participants to meet the target enrollment number within the study timeframe?
Yes
No*
2. Are the eligibility criteria reasonable to meet the enrollment target?
Yes
No*
3. Will any of the following factors impede enrollment of participants on this study at Children’s Health?
- Age
- Duration of study
- Frequency of study-related procedures
Yes
No*
4. Is there a clear plan of action (with appropriate resources) for recruiting participants?
Yes
No*
5. Is there an available source of potential participants at Children’s Health?
Yes
No
• If yes – is the internal source outside of the PI’s department and has that other department provided approval of recruitment activities (e.g., Emergency Department).
Yes
No*
• If no – is there an external, local source (e.g., physician offices) that may be utilized to recruit potential participants?
Yes
No*
6. Does the study require long-term research-related follow-up visits?
Yes
No
• If yes – is there a plan in place to address participant dropouts and attrition?
Yes
No*
* If a “No” with an asterisk is checked above, this study may not be feasible to conduct and complete at Children’s Health.
III. ProceduresandResources
1. Does the study have adequate funding to pay for all planned procedures and staff time?
Yes
No
• If no – will additional funding support be available and approved?
Yes
No*
2. Is current or planned staffing adequate to successfully conduct the study?
Yes
No
Version 06/22/2017