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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q020
SOP Title: Adult Research Patient at Children’s Health
sections of the request.
9. Subcommittee voting members and/or their designees will review the request, ask questions, and may seek follow-up, if applicable. . For each request, sub- committee voting members will document their approval in C-360.
10. Following Research Compliance Subcommittee voting members approval, an email notification apprising Research Administration that request is ready for final approval will be submitted via C-360.
11. The assigned Quality Specialist will be responsible for manually sending the approval notification by selecting “Send PI Notification”. Members of the study team (PI and requester) will receive an email notification informing them of the final approval. Research Administration mailbox will be copied on the notification to the study team.
An example of an approval correspondence:
“Your request for adult patient enrollment was approved by the Children’s Health Research Compliance Committee on ___________ (enter date). You are approved by Research Administration to enroll up to _______(enter # from section 2-4) with the maximum age of the adult subject being _________(enter # from 2- 3).
SOP No. 22, 06-02-22