Appendices Risk Assessment Tool Protocol EUdraCT number Sponsor Centers evaluated Assessors involved Date and version of risk assessment Topics Items CONSIDERATION LIKELIHOOD IMPACT DETECTABILITY MANAGEMENT CONTROL BY (to be adapted) OF POSSIBLE STRATEGY FOR monitoring RISKS MITIGATION OF RISK (protocol, agreements monitoring plans, SOPs, training, plan or monitoring etc.) Communication plan organisation Financial Resources and Agreement governance SOP and Quality systems
Appendices Risk Assessment Tool Protocol EUdraCT number Sponsor Centers evaluated Assessors involved Date and version of risk assessment Topics Items (to be adapted) CONSIDERATION OF POSSIBLE RISKS LIKELIHOOD IMPACT DETECTABILITY MANAGEMENT STRATEGY FOR MITIGATION OF RISK (protocol, agreements monitoring plans, SOPs, training, plan or monitoring etc.) CONTROL BY monitoring organisation and governance Communication plan Financial Resources Agreement SOP and Quality systems