Page 137 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
6. PROCESS MAP
Research Administration SOP No: Q003
SOP Title: COG Performance Site Review / Approval Process
Start
CCBD Coordinator
Contacts research quality specialist by phone/email and provides a COG PSA submission in Velos.
CCBD Coordinator
Provides the following to be uploaded into Velos Documents tab •1572 Document (if applicable) •Delegation log
RQS
Updates Study status in Velos to “Received- Pending Review.
RQS
• Verifies team members credentialed & have completed Children’s Research modules
• Verifies team members listed in eIRB, delegation logs, and PSA (Excluding financial support staff).
RQS
Prints pertinent documents for records.
Did the study have IRB approval at time of PSA request notification?
RQS
Approval Granted in Velos upon eIRB approval
RQS
Sends email to Medical Director for study approval.
RQS
Follow up email sent to CCBD team on approval with follow up questions/documents
Yes
No
PSA granted subsequent to IRB approval
RQS
Formulate questions and review with manager.
End
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q003
12/01/21
Summary of Changes –
• Addition of Andrew (Andy) Hebert as an author
• Addition of Acronyms
Q003
SOP No. 1, Date: 4/13/16; revised 5/3/16, 7/5/16; 8/2/16; 10/13/16; 03/18/19; 04/03/20; 08/19/21