Glossary

The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk".

(ICH Q9) Combination of the probability of occurrence of harm and the severity of that harm. (ISO/IEC Guide 51)

Likelihood of an identified harmful consequence as a function of exposure to a hazard.

(ICH Q9) The decision to accept risk. (ISO Guide 73)

Systematic use of available information to identify hazards and to estimate the risk.

(ICH Q9) The estimation of the risk associated with the identified hazards.

Estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of the risk.

(DOD) A comprehensive evaluation of the risk and its associated impact.

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

A methodology, conducted during the design of the facility, to determine, analyze, and manage potential risks to product quality.

(ICH Q9) A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

Overall process comprising a Risk Analysis and a Risk Evaluation.

An educational process through which a genetic counselor attempts to interpret how a genetic condition is inherited and the chances that it might be passed on to children.

(ICH Q9) The sharing of information about risk and risk management between the decision maker and other stakeholders.

(ICH Q9) Actions implementing risk management decisions (ISO Guide 73)

Process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels.

(ICH Q9) The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.

Judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context.

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.Risk evaluations consider the strength of evidence for all three of the fundamental questions:1)What might go wrong?2)What is the likelihood (probability) it will go wrong?3)What are the consequences (severity)?

A systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders.

(ICH Q9) A systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.

Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, and controlling risk.

(ICH Q9) Systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk.

(ICH Q9) Actions taken to lessen the probability of occurrence of harm and the severity of that harm.

(ICH Q9) Review of monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.