Table 2 Example of assets and risk scenarios for risk elements in the domain Overall Study Management (Part A) and Participant Safety and Rights (Part B). Assets that apply to all trials are marked in red
A) | Â | Â | Â |
|---|---|---|---|
Domain | Risk element | Asset | Risk scenario |
Overall Study Management | Participant Schedule | Visits/Phone calls must be within the given Timeframe | (A) Time point of visit is critical for the endpoint assessment of the study |
(B) Large number of visits are difficult to organize and coordinate between centres and patients | |||
B) | Â | Â | Â |
Domain | Risk element | Asset | Risk scenario |
Participant Safety and Rights | SAE/AE | SAE have to be reported and documented correctly in the required timeframe | Complexity of CRF or missing SOPs for SAE Reporting leads to (A) Incorrect documentation and (B) Delayed reporting of SAEs |