Preferred Label : Process Protocol;
NCIt related terms : ProcessProtocol;
NCIt definition : A standard operating procedure (SOP) that is a collection of activities and the rules
that describe when each activity is performed to achieve a specific purpose or objective(s).;
Alternative definition : BRIDG 5.3: A standard operating procedure (SOP) that is a collection of activities
and the rules that describe when each activity is performed to achieve a specific
purpose or objective(s). EXAMPLE(S): Specimen Collection Protocol; Specimen Processing
Protocol; Image Acquisition Protocol OTHER NAME(S): NOTE(S): In modeling, often the
same term is used to mean different things and a single concept can have more than
one name. In the healthcare arena, the term protocol is somewhat overloaded and must
be qualified to provide semantic context. Therefore during the early years of the
BRIDG project, the term study protocol was chosen to disambiguate the concept of the
detailed plan for a clinical study (the scope of BRIDG at that time) from other kinds
of protocols such as are common in life sciences. In BRIDG, the notion of a study
protocol is very specific in purpose and includes (but is not limited to) the design,
statistical considerations, activities to test a particular hypothesis or answer a
particular question that is the basis of the study, characteristics, specifications,
objective(s), background, pre-study/study/post-study portions of the plan (including
the design, methodology, statistical considerations, organization). For a more complete
discussion of the notion of the study protocol see the classes StudyProtocol, StudyProtocolVersion,
StudyProtocolDocument, StudyProtocolDocumentVersion, StudyConduct and all their associations.
With the addition of life sciences to the scope of the BRIDG model, there came along
(with that scope) the need to identify the kind of protocol that represents a more
simple or atomic concept, that of a composite activity that serves as a rule that
guides how activities should be performed. This concept, represented by the ProcessProtocol
class, has a more limited size than the concept of a study protocol does and represents
a standardized approach to doing tasks or activities that are not as big as the plan
for a whole study. The BRIDG SCC acknowledges that overloaded terms are problematic.
The SCC recognizes that many different users within the BRIDG community will have
differing opinions on what the meaning of a term is, which term is the best to use
for each concept, and how to define them most effectively. Given that the real meat
of a concept is in the definition, the BRIDG SCC aims to choose the most unambiguous
term to use as the class name, to make the class definition as explicit and clear
as possible, to provide sufficient examples and other names to illustrate the range
of possible instances that could be represented by the class. So the BRIDG model is
maintaining the distinction between a ProcessProtocol and a StudyProtocol because
there is a distinction in the domain that we're trying to disambiguate - the concepts,
attributes and relationships that describe an SOP-like, atomic, reusable ProcessProtocol
are very different than those of a full-blown clinical trial StudyProtocol. Linking
the classes because they both contain the same overloaded word would create artificial
complexity in the model and not serve the ultimate purpose of interoperability across
systems that need to exchange biomedical research data.;
NCI Metathesaurus CUI : CL977593;
Origin ID : C164368;
UMLS CUI : C5236191;
Semantic type(s)
- concept_is_in_subset
