Page 489 - eBook Version 8 Book 1 of 2 JUL 2022

Study Start-Up: PSA Submissions
eIRB
Select
Comments
Have you completed the eIRB smart form application in full?
Yes No
Have you selected Children’s Health for resource, recruitment, and procedures (as applicable)?
Yes No
Have co-investigators agreed to be a part of the study in eIRB?
Yes No
Has your principal investigator (PI) submitted the study to the IRB for review?
Yes No
Has the department chair reviewed and approved the study to be routed to the IRB for review?
Yes No
For cancer trials, have you requested the Protocol Review and Monitoring Committee (PRMC) at UT Southwestern to review your study (as applicable)?
Yes No
When IRB stipulations are received, have members of the research team addressed each point and submitted their responses to the IRB for review?
Yes No
Has IRB issued approval for your study including associated documents (e.g. IC, HIPAA, advertisements, protocol, questionnaires, IB, lab manual, etc.)?
Yes No
Performance Site Review
Select
Comments
Has a Clinical Trial Coverage Analysis been reviewed and PI approved?
Yes No
For studies with billable services (e.g., labs, pathology, imaging, etc.), has a service order agreement (SOA) been initiated? For more information, please access the Service Order Agreement Checklist.
Yes No
For studies that utilize Children’s Health Laboratory and Pathology services, have you submitted your study to the department for review and have you received approval Research Support Letter from the Lab letter?
Yes No
For studies with billable services, has your SOA been fully executed by both UTSW and Children’s Health Research Administration?
Yes No
For studies that are industry supported (pharmaceutical companies), have you initiated a request for a Facility Use Agreement? If not, please contact a member of Children’s Health Research Administration for more information.
Yes No
Have you received Performance Site Approval from Children’s Health Research Administration?
Yes No
For studies with billable services, has a research account been created by Children’s Health Finance Team? If not, please contact a member of Children’s Health Finance Team at Research.Finance@Childrens.com.
Yes No
Version Date: 7/28/17
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