Page 167 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
Velos. Notifications will be placed in the “Study Approved” subfolder in the Research_Department Inbox.
• ACTIVATED – Minimum approvals received - 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 Velos. Notifications will be placed in the “Study Approved” subfolder.
• NOT Activated – IRB Approved, Other Approvals Pending - 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 Velos. Notifications will be placed in the “Study Approved” subfolder.
• Securemail: Velos Notification: Children’s Medical Center Site Approval Request for Study #_____ - (Refer to SOP No: 3a and SOP No: 3b Performance Site Approvals Process for more details) – Quality Specialists will process the requests for site approval. Upon PSA approval by Children’s Medical Director, the email notifications will be moved into the PSA Notifications share folder under Research_Department Inbox.
• CMC – Notice of Study Lapse (Refer to SOP No: 2 Lapsed IRB Study Process for more details) - A member of the Quality Specialists team will verify if continuing review has been submitted and approved by IRB. For projects in which the researcher has not initiated a continuing review request in the eIRB, a lapsed letter notification will be emailed to the researcher within 3 business days of CMC Research Administration being notified of the study lapse in the Research Mailbox.
• Annual Update – CMC Review: Notifications will be placed in the subfolder named “CMC – Annual Updates & CR Approved E-mails”.
• Continuing Review – CMC Review - At the end of each business day, notifications will be saved in the subfolder named “Annual Updates & CR Approved E-mails.”
• CMC – CR Approved – Acknowledgment Notices – At the end of each business day, these emails will be saved under the folder titled “Annual Updates & CR Approved E-Mails.
• Data Analytics Correspondence – Data Analytics requests are now being housed in their own general e-mail box called “Research-Data Requests,” and any
SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020; 8/26/2021, 05/31/22