Preferred Label : Clinical Trial Qualified Person Investigational Product Certification Documentation;
NCIt related terms : Qual Person Cert; Qualified Person Certification; QP Certification; QP (Qualified Person) Certification;
Alternative definition : CareLex: A document provided by a Qualified Person that confirms the investigational
product (IP) has been manufactured and checked in accordance with the standards of
Good Manufacturing Practices (GMP) and at least equivalent to those required by applicable
regulatory agencies. [Adapted from TMF-RM]; CDISC: Documentation from a Qualified Person confirming that the investigational product(s)
for the clinical trial have been manufactured according to Good Manufacturing Processes.;
Origin ID : C115720;
UMLS CUI : C3897808;
Semantic type(s)
- concept_is_in_subset
