Page 166 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
business day, a member of the Quality Specialists team or designee will review the Research mailbox for Modification approval notifications. For personnel changes, verification of credentialing as well as completion of Children’s Research Administration (RA) required training will be performed. Research site personnel will be contacted if new staff members are not credentialed and have not completed RA required training. This process will be tracked on a shared Excel spreadsheet in Children’s Share Point. A schedule has been developed by the QS team to assign daily review of modifications: Saturday/Sunday/Monday (Kita Cathey), Tuesday/Wednesday (Mike Molai), Thursday/Friday (Andy Hebert).
• CMC – Modification Submitted – “MOD Submitted” notifications will be reviewed in real time by the assigned Quality Specialists. Assigned QS team member will only log and track MOD submitted types which involve updates to the protocol. Depending on the change, a service order agreement (SOA) may also need to be amended. Quality Specialist team members or designee will notify the researcher and CMC key stakeholders regarding an update to the SOA. For all other MOD submitted notification types (personnel, consent/HIPAA, recruitment, other), Quality Specialist team members will delete these e-mail notifications from the RA mailbox.
• Affiliated Study Personnel Updated - At the end of each business day, a member of the Quality Specialists team or designee will review the Research mailbox for personnel notifications. For personnel changes, verification of credentialing as well as completion of Children’s Research Administration (RA) required training will be performed. Research site personnel will be contacted if new staff members are not credentialed and have not completed RA required training. This process will be tracked on a shared Excel spreadsheet in Children’s Share Point. A schedule has been developed by the QS team to assign daily review of modifications: Saturday/Sunday/Monday (Kita Cathey), Tuesday/Wednesday (Mike Molai), Thursday/Friday (Andy Hebert).
• Submit Study – CMC Review – A member of the Quality Specialists team will log study in a shared tracking log in Children’s Share Point., and depending on the nature of the study, it will be identified and assigned to one of three Quality Specialists to begin review. Following initial review, a completed workbook detailing requests and questions will be sent to the PI, PRC, and PAC for review. The e-mail notifications will then be moved into the Study Submitted share folder under Research_Department Inbox.
• CMC – Study Approved - Members of the Quality Specialists team will continually track logged studies listing Children’s as a Performance Site and will follow-up with those investigators who have not requested a Performance Site Review in
SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020; 8/26/2021, 05/31/22