Submission Unit

Definition 1

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. (NCI Thesaurus)

Definition 2

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. (NCI Thesaurus/BRIDG)

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Submission Type Code

A coded value specifying the kind of submission.

Submission Sub-Type

A description of the types of submissions made to a submission type (regulatory activities) accepted by regulatory agencies.

Submission Status Date

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

Submission Status Code

A coded value specifying the phase in the lifecycle of the submission.

Submission Receipt Date

The date (and time) on which the first submission unit is received by the regulatory authority.

Submission Domain Abbreviation

A unique, 2-character domain code used in the regulatory submission process. The domain abbreviation is used consistently throughout the submission,…