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F

Glossary

factor

In IWRS, factors are the conditions that influence subject randomization and drug dispensing.

For example, they determine to which cohort the subject is assigned, what treatment receives at a certain visit, and so on.

There are three types of factors in IWRS:

  • Treatment-specific: the value of the factor is set at each treatment.

  • Visit-specific: the value of the factor is set once at a visit.

  • Subject-specific: the value of the factor is set once for a subject.

fee category

A category of fee items—services or occurrences—intended for financial compensation grouped by their type or intention, such as institution management, adverse event management, and so on.

fee item

An individual service or occurrence intended for financial compensation, such as drug distribution, data storage, equipment usage, subject visit performance, and so on.

Food and Drug Administration (FDA)

A national regulatory agency that controls the development of new drugs and standards compliance by clinical trial researchers.

Learn more about FDA on the official website.