Study Protocol Version Participating Country Code

A coded value specifying the countries from which participants will be, are intended to be, or have been recruited for the study. (NCI Thesaurus)

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Study Protocol Version Multi-institution Indicator

Specifies whether a study is designed to be conducted at more than one site concurrently.

Study Protocol Version Mandatory Indicator

Specifies whether the modifications contained in the study protocol version must be applied to all sites and subjects that want to continue…

Study Protocol Version Design Configuration Code

A coded value specifying a trial pattern developed to compare treatment groups in a clinical pre-clinical trial.

Study Protocol Version Condition Coding System

The coding system used for recording conditions that are the focus of a study.

Study Protocol Version Companion Code

A coded value specifying the type of ancillary study.

Study Protocol Version Amendment Grace Period

The period of time during which sites can continue to accrue on an existing study version before they are required to switch…