Risk assessment
Risk management planning should take as much priority as project planning. The goal is to assure that the study is carried out correctly so that the outcomes are reliable and valid, and participants are safe. Plans will be put in place for monitoring participant safety and reporting safety data according to sponsor, ethics committee and regulatory authories
- Any risks to the safety of patients and those who carry out the study, and to the integrity of the data should be identified in advance where possible so they may be mitigated.
- Data collected during the study must be reliably and correctly gathered, carefully entered into the appropriate clinical record form and safely secured. If that is not done, the study cannot fulfill its purpose.
View the related resources
Procedure
SAF06
General evacuation of the clinical trial facility
A process for the evacuation of a clinical trial facility in the event of a non-medical emergency
Version: v2.0 Author: WWARN
Procedure
SAF02
Evacuating a patient in the event of a medical emergency
A process for safely evacuating a patient due to a medical emergency from the clinical trial facility
Version: 2.0 Author: WWARN
Procedure
SAF03
Post-exposure prophylaxis in the clinical trial facility
A process for dealing with inadvertent exposure to potentially infectious fluids during a clinical trial
Version: 2.0 Author: WWARN
Procedure
QA07
Trial risk assessment (by the site)
A process for assessing the risk of an institutional team conducting a trial
Version: 2.0 Author: WWARN
Procedure
SAF01
Safety assessment and reporting
A process for the identification, management, assessment, and reporting of adverse events/adverse drug reactions
Version: v1.0 Author: WWARN