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

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