Please enable JavaScript.
Coggle requires JavaScript to display documents.
SSUS Processes (Site Activation Final Checks (Update CTMS (Site Mgmt Tab,…
SSUS Processes
Site Activation Final Checks
GLF
Budgets & Contracts
Vendor set up & training
CTSP access for sites
Update CTMS
Site Mgmt Tab
Site Recrmt Tab
Accounts Tab
Contacts Tab
Site & Country ICF Tracking
Site & Country Activity Plans
Handover Dates
Site Issues
SSU TP Space
Reg Docs in place
Budgets & Contracts
Request CM
KOM
CM creates template
LST finalizes template
BRC review
CM disseminates & negotiates
FMV escalations
Pre-Activation Visit (PAV)
Date determined
Collect pending docs
CRA Handover
Update CTMS Site Issues tab
IRB Submission
Central IRB
Finalize selection of IRB
Inform IRB
Get Account Mgr
Master Agreement
Initiate if not already in place
SOW needed for each study, requested via C4, would need a fee schedule (from IRB)
This done before submission
Submission
Country Level
Country level documents :warning:
Site Level
Work with sites
Country Specific/ICF
Localize
Essential Checklist (SRD-0105332)
Finalize & Obtain Approval
Archive in eTMF
Translate
Ethics Package
Protocol
IB
SUSARs
Localized ICFs
Study-specific material
questionnaires
scales
subject education tools
recruitment materials
PI signed
Gap file to eTMF
Local IRB
Send Country ICF
Site modify
Review site changes
Negotiate
Enter approved ICF into CTMS
File all correspondence in eTMF
Regulatory Submissions (US)
FDA submission done by SMT
Obtain info
Obtain IND letter
Obtain date of submission
obtain FDA approval for IRB
Essential Forms
PD20
PD30
PAF
FDF (SRD-0111254)
DOA
FDA 1572 (from site)
GLF
Feasibility & Site Selection (Later)
Country Level IRB etc