Clarification on comments re InVivoCharacterization

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Need clarification on comments re InVivoCharacterization (rows 9, FDA)

Ballot Comment

InVivoCharacterization as defined seems to include clinical trials and nonclinical (e.g. toxicology) studies. We need a better definition for this class, or Study is either a specialization of or synonym for this class.

Previous Definition

DEFINITION: The appraisal of the biological properties or activities of a substance by testing its effect on a organism.

EXAMPLE(S):

OTHER NAME(S):

NOTE(S):

Latest Definition

DEFINITION: An Experiment whose objective is the appraisal of the biological properties or activities of a substance by testing its effect on an organism.

EXAMPLE(S):

OTHER NAME(S):

NOTE(S):

Current Disposition

Persuasive with Mod

Proposed Disposition Comment

The definition of InVivoCharacterization came from LSDAM subject matter experts who are life sciences researchers. RECOMMENDATION: Work with life sciences SMEs and FDA representative to address this concern. Existing definition for reference: “The appraisal of the biological properties or activities of a substance by testing its effect on a organism.” DECISION: updated definition of all 3Experiment subclasses per WG discussion

Related Superclass Definitions for Reference

Project Definition: A set of coordinated activities that is intended to achieve one or more objectives.

ResearchProject Definition: A project that is intended to generate or test one or more hypotheses or lead to discoveries.

Experiment Definition: A Research Project whose objectives are to generate hypotheses or lead to discoveries.

Outstanding Question

• Does this definition need to exclude clinical trials and nonclinical studies or is that implied by the definition of its superclass (recommended)? View it in context of it’s super classes listed above.

Responses

Lauren Becnel: The denotation of the proposed definition is fine, but the connotation of the definition with the word “experiment” is awkward for clinical trials and toxicology studies. For example, you might be performing an in vivo characterization such as an MRI on a human. MRIs are standard of care. Within a clinical trial, you may have research MRIs that are part of the study, but not covered by payers as SOC for various reasons (i.e., too frequent occurrence, not recommended by AHRQ, etc.) This is then therefore a research procedure. While it is not incorrect to say this is a type of experiment,that word is not one that many trialists would use.

Recommend DEFINITION: A study or an experiment whose objective is the appraisal of the biological properties of an organism or activities of a substance by testing its effect on an organism.

Q from WENDY (TYPE: DEFN): In BRIDG, an experiment can be related to a Study and since InVivoCharacterization is a subclass of Experiment, it's OK to call it that if the only use case we’ve had so far is for experiments, right? We can leverage the association between a Study and an Experiment by use of the ProjectRelationship class.

DISCUSSION 20160225: Given that BRIDG has not yet had the requirements on the pre-clinical or clinical study side for physiochemical, in vivo or in vitro characterization activities and it was only LSDAM that has this requirement for such Experiment subclasses, we’ll going to leave the definitions as they are for now. If and when such requirements come to harmonization on the pre-clinical or clinical study side we’ll reconsider how to model those semantics then.

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