Preferred Label : Clinical Trial Safety Management Plan Documentation;
NCIt related terms : Safety Reporting Plan; Safety Management Plan; Safe Mgmt Plan;
NCIt definition : Documentation describing the safety evaluation process for investigational product(s)
during the clinical trial.;
Alternative definition : CareLex: A documented description clearly defining the end-to-end process for the
ongoing safety evaluation for the investigational product (IP). May include but not
limited to data to be collected, reporting objectives, and processes for a clinical
trial. Plan may also include but is not limited to associated documents for quality
management, safety database entry specifications and templates, and/or coding guidelines.
[Adapted from TMF-RM]; CDISC: Documentation describing the safety evaluation process of investigational product(s)
during the clinical trial.;
Origin ID : C115755;
UMLS CUI : C3899554;
Semantic type(s)
- concept_is_in_subset
