Preferred Label : Clinical Trial Vendor Qualification and Compliance Documentation;
NCIt related terms : Audit Certificate; Evidence of Contractor Compliance; Qualification of Vendor; Documentation of Decision to Utilize Third Party; ECC; Qualification and Compliance;
Alternative definition : CareLex: Documentation confirming that a third party meets, and continues to meet
throughout the study, all relevant criteria to fulfill a contractual obligation; may
include a quality questionnaire, a visit report to qualify their capabilities, other
documents that support capabilities. [Adapted from TMF-RM]; CDISC: Documentation confirming that a vendor meets all criteria to fulfill a contractual
obligation for the clinical trial.;
Origin ID : C115690;
UMLS CUI : C3889977;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
