Study Chair

Definition 1

A person who is responsible for providing overall management for the operation of the study, and for reporting to the Data and Safety Monitoring Board. The continual review of the data by an independent individual or DSMB assures the investigator(s) that the trial can continue without jeopardizing patient safety. (NCI Thesaurus)

Definition 2

A person who has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (Food and Drug Administration/CDISC)

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Study Category

The classification of the study.

Study Author

An individual, group, or organization primarily responsible for the content of a planned study. The author of the study is not necessarily…

Study Agent Unique Ingredient Identifier

The unique ingredient identifier of the investigational product under study.

Study Agent Status Date

The date (and time) on which the status is assigned to the study agent.

Study Agent Status Code

A coded value specifying the phase in the lifecycle of the agent's association to a study.

Study Agent Function Code

A coded value specifying how this agent is used in the study.