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WorkStreams (Site Initiation (SI. 6. Fast Track / Standard Site Selection,…
WorkStreams
Site Initiation
SI. 0. Investigator Portal Platform
Enterprise Investigation Platform
SI. 1. Site Activation
Sponsor & Site Startup process
Rollout Pharma 2018 - other Sectors 2019
SI. 2. VTMF Cross Sector
SI. 3. Wet Signature Documents
SI. 4. Investigator Debarment Check
on hold - pending technology assessment 2019
Harmonized debarment check parameters
automated technology process
SI. 5. Country / Site ICF Fallback language
ICF will not be harmonized
cancelled
SI. 6. Fast Track / Standard Site Selection
on hold
criteria & decision process for recommendations
who will manage
decision tree
On site/ remote PTAV
Fast track criteria for activation
SI. 7A. Harmonized Templates ICF checklist
SOPs will not be harmonized
ICF checklist - currently pilot
SI. 7B. Harmonized CDA Templates
SI. 7C. Harmonized ICF version tracker
ICF Tracker
automated VTMF report
SI. 7D. Harmonized PTAV & SIV templates
launched in Pharma
letters harmonized
reports will not be harmonized
Study Managment
SM. 0. Playbook
Cross Sector SM Playbook
comprehensive guidance roadmap
align w/ Summit, TruVault, ARIS
SM. 4. Harmonized Feeders
revise SM processes & docs - used in other JJCO WS
ProcDocs, trainings, etc
Enterprise Monitoring
EM. 1A. ARBM SMART Deployment
pilot successful
EM. 1B. ARBM SMART Tool
Enterprise wide implementation
Tool, job aid, ...
EM. 2A. Site Data Storage Process
depending on timelines of Cross-sector approach
eSource SOP
Source Doc Identification Form
EM. 2B. Transfer of Responsibilities process
transition report
ToR process - ToR report instruction
EM. 3A. Monitoring Visit Reports
harmonized MVR templates
SOPs, WIs
EM. 3B. Monitoring Visit Letters
letter templates
Implementation JJCO Letters in One CTMS
OK in Pharma - awaiting MD - not in Cons & VC
EM. 4A. ARBM Process
SOP on harmonization ARBM & supporting docs
doc review ongoing
EM. 4B. Integrated Monitoring Process
ProcDocs
GAP assessm by sectors
EM. 4C. TCF / TMF / ICF
EM. 7. Issue Managment
closed?
MD: own issue escalation module
EM.8. one CTMS Deployment
sector specific updates?
single CTMS system in all sectors
Data Managment
E2E Process
ProcDocs
Lvl 2 harmonization
different approach than other WS
Evaluating use of Playbook (SM. 0.)