Preferred Label : Expanded Access Study Protocol Version;
NCIt related terms : ExpandedAccessStudyProtocolVersion;
NCIt definition : An action plan of a pre-clinical or clinical study describing the procedure for obtaining
an experimental drug or device for patients who are not adequately treated by existing
therapy, who do not meet eligibility criteria for enrollment, or who are otherwise
unable to participate in a controlled clinical study.;
Alternative definition : BRIDG 3.0.3: An action plan of a pre-clinical or clinical study describing the procedure
for obtaining an experimental drug or device for patients who are not adequately treated
by existing therapy, who do not meet eligibility criteria for enrollment, or who are
otherwise unable to participate in a controlled clinical study. NOTE(S): This type
of study is used to register all types of non-protocol access to experimental treatments,
including protocol exception, single-patient IND, treatment IND, compassionate use,
emergency use, continued access and parallel track. (Parallel track means there is
separate group of subjects that go through the same protocol activities but that didn't
get on the main trial due to different reasons such as eligibility criteria, location,
etc. and their outcome data is collected and analyzed, just not analyzed with the
other data, rather in parallel.);
Origin ID : C93485;
UMLS CUI : C2985695;
Semantic type(s)
- concept_is_in_subset
