{"id":471,"date":"2018-05-30T08:34:12","date_gmt":"2018-05-30T08:34:12","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/glossary\/medschool-glossary-protocol-exception\/"},"modified":"2024-12-04T21:26:27","modified_gmt":"2024-12-04T21:26:27","slug":"protocol-exception","status":"publish","type":"glossary","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/protocol-exception\/","title":{"rendered":"Protocol Exception"},"template":"","class_list":["post-471","glossary","type-glossary","status-publish","hentry"],"acf":{"glossary_term_description":"Term used by FDA and some sponsors to refer to a departure from the protocol that receives approval from the IRB before implementation (a one-time exception as distinguished from an amendment to the protocol). Approval requests for a protocol exception should be submitted using the ORIO submission in eResearch. Investigator should specify the extent of the exception (e.g., one-time only for patient X and note if data will be included in the study analysis). If the exception is to become a permanent change, an Amendment submission in eResearch needs to be submitted.","glossary_related_terms":"","legacy_glossary_node_id":707,"legacy_related_terms":""},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/471","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/glossary"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}