Responsibilities
Responsible person for Feasibility on Country level.
CLM
Name the 3 key success factors for feasibility.
Start early
Get external & internal insights
Do robust data collection, analytics and modelling
What does "ASP" stand for and what is the purpose?
ASP stands for Adjustable Study Planning. It displaying our standard business processes following standardized trigger points. go/ASP
This is the place to find details and training on the Feasibility process.
The TFA Sharepoint. Go/TFA
Overall responsible person (lead) for the Feasibility Process.
The Feasibility Strategist
The Core Team together with the Feasibility Strategist will roll out dedicated live sessions to the country teams.
Timepoint (ASP trigger) to start Site Feasibility?
PL 1 - around 6 - 9 months before planned FPFV
The system used to set up the FS survey and send it to sites.
VEEVA (since November 2022)
Role to kick off FS process.
The CPM
Name the phases in Feasibility.
Protocol Optimization, Protocol Feasibility, Site Feasibility
The timing following ASP trigger to kick off Protocol Optimization.
PO can be kicked off with COR (Clinical Operations Roadmap) available
The system to find benchmark trials from competing companies.
Citeline
Responsible to baseline country enrolment numbers in IMPACT.
The CLM will baseline country level enrolment numbers in IMPACT (via CSI) .
Timepoint to baseline enrolment numbers in IMPACT
Within 5 working days after country confirmation
Useful tool to help enrolment which can be found from ASP.
The study specific enrolment plan templates - for global, country and site level - can be found from the ASP platform.
Database (internal) providing information on regulatory country requirements and timelines.
CORD
Responsible for Recruitment and Retention Plan development.
The SLM will develop the global R&R - together with the R&R team - and based on input gained during feasibility. Site level R&R plan: CRA. Country level R&R plan: CLM
The percentage that clinical trials fail to meet enrolment goal.
approx. 80%
The timepoint to develop country budget planning.
At PL 2 country specific budget planning will start by developing country budgets based on FMV budget workbook.
Systems (4) helping identify historical timelines for study conduct.
CiteLine, CORD, TrialTrove, SiteTrove