Page 168 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
correspondence received in the general RA Mailbox regarding data requests can be moved to the “Research-Data Requests” mailbox for further processing. See SOP# 23 Data Requests for further information on processing data requests.
• Reportable Event – CMC Review – A member of the Quality Specialists team will review and file all HRPPO RE notifications. QS will forward HRPPO RE notifications (if an SAE occurred at Children’s) to RA Administration for acknowledgement.
• CMC – Notice of Study Closure – Once a notice of closeout is received, QS will place notice in the subfolder “Study Closures”. The Finance Team will bundle these periodically and process for outstanding invoices / charges.
• Securemail:No Action Required – Velos Notification: Children’s Medical Center Granted Site Approval for Study #_____ - (PSA Approval notifications) – Kahn – All PSA approval notifications will be filed for future access in the subfolder “PSA Approvals – Kahn.”
Templates and/or any written processes or letters will be sent to Victoria Brown, Director of Research Administration, for approval and will return to Quality Specialists team members.
4. PROCESS MAP
5. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q001
08/01/2022
• Removal of Jayni George, and Victoria Brown
• Addition of email assignment by color code
• Removal of process map as it was outdated.
Q001
SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020; 8/26/2021, 05/31/22