Preferred Label : Protocol Approval by Sponsor;
NCIt related terms : protocol approval (Sponsor);
NCIt definition : An indication that the sponsor, including all reviewers, have approved the protocol.;
Alternative definition : CDISC-GLOSS: Sponsor action at the completion of protocol development that is marked
when the signature of the last reviewer on the protocol approval form has been obtained,
signifying that all reviewer changes to the protocol have been incorporated. NOTE:
Approval by the sponsor usually initiates secondary approvals by IRBs, regulatory
authorities, and sites. Protocol amendments usually also require a cycle of approval
by sponsor and study staff prior to taking effect.;
NCI Metathesaurus CUI : CL540623;
Origin ID : C142648;
UMLS CUI : C4684741;
Semantic type(s)
- concept_is_in_subset
