Page 127 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
• PSA Notifications – PSA requests submitted by research team in Velos will be acknowledged and filed for future access.
• PSA Approvals – Kahn – All PSA approval notifications (from Dr. Jeffrey Kahn) will be filed for future access.
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
Quality Specialist
CMC – Mod
Approved
Submit Study
Continuing
Review – CMC
Quality Specialists
CMC –
Modification Submitted
CMC – Notice
Children’s
Medical Center Site Approval Request
CMC – Study
Approved
– CMC Review
of Study Lapse
Review
RQS
End of business day, review Research mailbox for MOD approval notification
RQS
Delete emails
RQS
End of each business day, delete emails
RQS
End of each business day, delete MOD submitted email notifications
RQS
Verify if continuing review has been submitted/ approved by IRB
RQS
Verify credentialing and process for request for site approval
Perform verification of credentialing and completion of CHEX training
Contact research personnel
No
Yes
Track on shared Excel spreadsheet
If continuing review request not submitted to eIRB, send lapsed letter notification to researcher within 3 business days of CMC Research Admin being notified
After PSA approval, move email to PSA Notification shared folder
RQS
Send introductory email to researcher
Move email notification to Study Approved shared folder
New Staff Credentialed and/or completed required training?
Clinical Research
Clinical Research
CMC-CR Approved
Quality Research Specialist
Team Lead
Purge email notification
End of the month, forwards email notification to team lead
SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020