Submission Unit

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70709

The collection of documents provided to the regulatory authority at one time. NOTE(S): A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document. In the dynamic aspects of the model, a submission unit is one message that may have a collection of many documents. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.

The collection of documents provided to the regulatory authority at one time. EXAMPLE(S): OTHER NAME(S): NOTE(S): A submission unit is made up of one to many document versions. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document versions. In the dynamic aspects of the model, a submission unit is one message that may have a collection of many document versions. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.

C70709

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C159503

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C159501

BRIDG

A collection of documents pertaining to a particular clinical study protocol and/or medical product accompanied by the associated reference information officially provided to the regulatory authority. This is usually done to comply with a specific regulatory purpose or decision.

Submission Unit

SubmissionUnit

Regulatory Submission Unit

Submission Unit

Submission_Unit

Submission Unit

Thesaurus:C70709

Submission Unit

Intellectual Product

C2348586

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C19498