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On-Study Change - Coggle Diagram
On-Study Change
Change
is
significant
Significant change in design
Change in participant population (including addition of patient arm)
Feasibility required
PM circulates proposed change
BD input for commercial sensitivity
PM collates feasibility data and provides to xxx
xxx ratifies decision to proceed or decline
PM articulates outcome to Sponsor
CD input for additional vendor requirements
Functions review for operational feasibility (Clin Ops, Pharm, Lab, Coord)
CMO/PI reviews for scientific integrity and PI resourcing
B&C input for cost estimate
change in assessments (requiring new equipment or additional vendor or vendor change in scope)
additional site added
Change
is not
significant
change in proposed dose level(s)
PM circulates details of the proposed change
Impacted functional teams review
Feedback from PI/ functions is collated and shared by PM with Sponsor
Once any updates are made and PI/ Functions approve, PM will submit to NN E&R
(PI approval notification required)
PI reviews
addition of standard assessments
additional cohort(s), no change to participant population or assessment