Page 177 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
5. PROCESS MAP
Research Administration SOP No: Q008
SOP Title: Expanded Access Program / Compassionate Use Protocols
RQS
Review study staff approved by IRB for credentialing/ training completions. Note any deficiencies and contacts for completion.
RQS
Review study documentation in eIRB
RQS
Send Acknowledgement letter to Principal Investigator
Start
Principal Investigator
File study regulatory documents
End
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q008
12/01/21
Summary of Changes –
•Addition of Andrew (Andy) Hebert as an author •Addition of Acronyms
Q008
SOP No. 7, Date: 4/20/16, 11/29/18; 08/19/21