Page 169 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Study Preparation Checklist
Select
Comments
Have non-Children’s Health staff members listed on the
study eIRB staff list completed credentialing at Children’s
Health?
If not, please utilize the following resources for more information:
□ For fellows/residents, contact Jennifer Rogers at Graduate Medical Education:
Medical_Education@childrens.com
□ For medical students, contact Peds.Clerkship@Childrens.com
□ For research staff/faculty, contact Lisa Martin: CVO@Childrens.com
Yes No
eResearch System Access
Do members of your study team have access to eIRB and Velos systems? For those that require access, please access the following link and complete a request on their behalf: https://ais.swmed.edu/redcap/surveys/?s=UH6mer
Yes No
Have all staff members on your eIRB staffing plan completed training at both UTSW and Children’s Health?
□
□
□
Complete UT Southwestern Human Subjects Training via CITI Programs
Human Subject Protection (HSP)
HIPAA Research
Good Clinical Practice (GCP), if protocol is clinical trial
Conflict of Interest (COI)
Complete Children’s Health required trainings via Cornerstone®
o Research 101 training (new staff)
o Research training (established staff)
o EPIC - electronic health record (if required)
o IATA - Shipping of Dangerous Goods Training (if required) o Blood borne pathogens training (if required)
Complete Annual COI Statement
Yes No
Study Resource Allocation
Has a performance site feasibility assessment or resource allocation been performed? Tools to assist with FA or RA include:
o Children’s Health site Feasibility Assessment Tool is available in the Researcher Toolkit
o Contact Children’s Health Data Intelligence for patient volumes
Have key departments who would assist with your study been contacted? Examples of departments that assist with studies include:
o Investigation Drug Services Pharmacy o Investigational Lab/ Pathology
o Radiology
o Cardiology
Yes No
Study Team Roles and Responsibilities
For studies that require a Delegation of Authority (DOA), has one been completed? At template Delegation of Authority log is available in the Researcher Toolkit.
Yes No N/A
Version Date: 7/28/17