Page 64 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
6. PROCEDURE PROCESS MAP
Research Administration SOP No: R-Reg-004 SOP Title: Study Initiation with Pharmacy
D021
Upon notice of New Study email Investigational Drug Service: 1) Protocol
2) Investigators Brochure
3) Pharmacy Manual
4) Estimated Study Start Date 5) Number of Subjects
Notification of Meetings to Initiate Study
Update Investigational Drug Service of study approval status
Update Investigational Drug Service with current versions of: 1) Protocol
2) Investigators Brochure
3) Pharmacy Binder
Set meeting with investigational Drug Service and Principal Investigator to order Investigational Product in EPIC
Review study documents
Build order set for investigational product in EPIC
Meet with Principal Investigator and CRC
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R009
10/01/20
Updated UTSW regulatory team lead role; added CRER process and NTF
R009
R009
04/01/21
Updated contacts
R009
Page 5 of 6
Investigational Drug Service
CRC Start
Finish