Page 310 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q020
SOP Title: Adult Research Patient at Children’s Health
For studies that do not receive approval, study team will receive the following:
Your request for adult patient enrollment was reviewed by the Children’s Health Research Compliance Committee on _____________ (enter date). At this time, Children’s Health Research Administration has elected not to approve your request. Please contact Children’s Research Administration or your assigned Research Quality Specialist for more information.”
12. Requests that have gone through the review process will be moved over to the “Logged/Reviewed” folder for future reference.
5.2 PI, PRC, & PAC
For studies where an adult patient population aged ≥ 19 years will be recruited, consented, and study procedures performed at Children’s HealthSM, members of the research team will utilize the C360 QRG to complete the intake form for Adult Patient Recruitment.
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q020
08/01/2022
• QRG – Created new QRG for C- 360 Adult Patient Recruitment request for research team members.
• SOP Update - Transitioning from email to C-360 on-line request. They include:
1. Created Appendix section and Moved Acronyms to the end of the SOP.
2. Updated purpose
3. Updated eligibility determination
section
4. Under responsibilities, updated CHRA Quality Specialist responsibilities to include new language regarding transition from email to C-360 request for eligible studies.
5. Updated PI, PRC, and PAC responsibilities from email requests to C- 360.
6. Deleted Process Map
Q020
APPENDIX
SOP No. 22, 06-02-22