Page 56 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
6. PROCEDURE PROCESS MAP
Research Administration SOP No: R-Reg-003 Title: Initiating the Research Laboratory &
Approval Process
D015
Complete Access Section 1:
Template Study Information
Complete Section 2: Sample Collection / Preparation
Complete Section 3: Sample Transfer / Processing
Verify Section 4: Laboratory Technician Section
Send to Laboratory Technician for Review / Edits
Work with
Laboratory Store with Source Technician to Documentation
Finalize
Work with CRC / CRA to Finalize
7. CHANGEHISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R116
10/01/20
Included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible
R116
R116
04/01/20
Included lab DOA NTF; lab approval process
DXXX
R116
10/01/19
Included new lab sheet template
R116
R003
08/01/2022
Repurposed the SOP to include the Research lab initiation process
R116
Page 7 of 7
Laboratory CRC / CRA
Start
Finish