Comunication Escalation Process

Initial Request

The Trial Team PM communicates response request to Site Team (Site PI + Site PSC).

01

Escalation Step 1

If Site Team is unresponsive after follow-up, Trial Team PM may ask Trial PI to communicate response request to Site Team (Site PI + Site PSC).

02

Escalation Step 2

If Site Team is still unresponsive after follow-up, Trial Team PM to communicate response request to Site Team including Site PI + Site PSC + RCC PI + RCC Manager + Trial PI.
The RCC Team will be asked by Trial Team to intervene with unresponsive Site Team.
Possible corrective and preventive action (CAPA) report may be issued by Trial Team to ensure future timely responsiveness.

03

Escalation Step 3

If Site Team is still unresponsive after follow-up, Trial Team may evaluate Site for probation / enrollment suspension at the trial level. This may be warranted for not responding to queries regarding participant safety, non-compliance or other serious matters.

04

Escalation Step 4

The Trial Team will communicate Site probation to NINDS + NCC + NDMC Leadership to review if this is a pattern across trials.
If pattern exists, NINDS + NCC + NDMC Leadership + RCC Team to intervene with StrokeNet level CAPA.