Preferred Label : Submission Unit;
NCIt synonyms : Regulatory Submission Unit;
NCIt related terms : SubmissionUnit;
NCIt definition : 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.;
Alternative definition : BRIDG 3.0.3: 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.; BRIDG 5.3: 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.;
Origin ID : C70709;
UMLS CUI : C2348586;
Semantic type(s)
- concept_is_in_subset
