The RACT is a risk-assessment questionnaire, which helps to study teams to evaluate various risk factors easy, e.g. the risk impact of compound interactions with other medications and the severity of subject population conditions.
The RACT can be used to facilitate risk assessment by helping to identify various risks and establish any associated mitigation plans. (…)
The purpose of the RACT is to facilitate risk assessment and risk mitigation.
Determine the risks that could affect subject safety, data quality or regulatory compliance
Identify how and by which function(s) the risks will be managed
Document risk mitigation in the individual functional plans which form the study’s overall Integrated Quality Risk Management Plan (IQRMP) (e.g. Data Review Plan, Statistical Analytical Plan, Safety Plan)