Page 487 - eBook Version 8 Book 1 of 2 JUL 2022

Site Initiation Visit Research Administration SOP No: R-Com-201 SOP Title: Site Initiation Visit
Once site activation has been issued by the sponsor, ensure that performance site approval has been granted by CHST initiate patient recruitment
5.5 Procedure Process Map
Start – Up Phase
Prior to Meeting
At Meeting D009
Ensure Complete Records of Regulatory Documents
1) Present Training
2) Verify Records Activate Study Site /
3) Confirm Site Team Informaiton
Obtain Approvals: 1) IRB
2) Performance Site Approval
Contracts / Budgets Completion
Provide Regulatory Document Approvals to Sponsor
Schedule Site Initiation Visit with: 1) Sponsor
2) Investigational Drug Service
3) Laboratory
Navigate between appointments with: 1) Sponsor
2) Investigational Drug Service
3) Laboratory
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R010
10/01/20
Added Study Start-Up Checklist; updated process to define the UTSW regulatory team lead’s role; included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible.
R010
R-Com-201
08/01/2022
Removal of COVID Restrictions & addition of new monitor processes
R010
Page 5 of 5
CRC / CRA Sponsor / CRO
Start
Finish