Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2022-09-30 CDISC-5753 Add C189351 Term Protocol Entity Terminology Protocol Entity Terminology Add new term to existing codelist - - - Study Blinding and Unblinding 2022-09-30 CDISC-5753 Add C142408 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Masked Medication 2022-09-30 CDISC-5753 Add C142742 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Study Unblinding 2022-09-30 CDISC-5753 Add C189268 CDISC Codelist Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Addition of new codelist - - - Study Blinding and Unblinding Attribute Terminology 2022-09-30 CDISC-5753 Add C189349 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Study Blinding Procedure 2022-09-30 CDISC-5753 Add C189350 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Study Unblinding Procedure 2022-09-30 CDISC-5753 Add C49068 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Study Blinding 2022-09-30 CDISC-5753 Add C49658 Term Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Add new term to new codelist - - - Study Blinding Schema 2022-09-30 CDISC-5753 Add C15228 Term TBLIND Trial Blinding Schema Response Add new term to new codelist - - - DOUBLE BLIND 2022-09-30 CDISC-5753 Add C156592 Term TBLIND Trial Blinding Schema Response Add new term to new codelist - - - OPEN LABEL TO TREATMENT AND DOUBLE BLIND TO IMP DOSE 2022-09-30 CDISC-5753 Add C187674 Term TBLIND Trial Blinding Schema Response Add new term to new codelist - - - OBSERVER BLIND 2022-09-30 CDISC-5753 Add C28233 Term TBLIND Trial Blinding Schema Response Add new term to new codelist - - - SINGLE BLIND 2022-09-30 CDISC-5753 Add C49659 Term TBLIND Trial Blinding Schema Response Add new term to new codelist - - - OPEN LABEL 2022-09-30 CDISC-5753 Add C66735 CDISC Codelist TBLIND Trial Blinding Schema Response Addition of new codelist - - - TBLIND 2022-09-30 CDISC-5753 Remove C49068 Term Study Design Attribute Terminology Study Design Attribute Terminology Remove term entirely from codelist Blinding - - - C49068 has become an attribute of the new Entity Study Blinding and Unblinding and is therefore no longer represented as an attribute of Study Design entity. 2022-09-30 CDISC-5753 Remove C49658 Term Study Design Attribute Terminology Study Design Attribute Terminology Remove term entirely from codelist Trial Blinding Schema - - - C49658 has become an attribute of the new Entity Study Blinding and Unblinding and is therefore no longer represented as an attribute of Study Design entity. 2022-09-30 CDISC-5753 Update C142175 CDISC Synonym Clinical Study Attribute Terminology Clinical Study Attribute Terminology Add new CDISC Synonym - - - Study Type Classification 2022-09-30 CDISC-5753 Update C112038 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition The condition, disease or disorder that the clinical trial is intended to investigate or address. The textual representation of the condition, disease or disorder that the clinical trial is intended to investigate or address. 2022-09-30 CDISC-5753 Update C112038 CDISC Synonym Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Add new CDISC Synonym - - - Trial Disease/Condition Indication Description 2022-09-30 CDISC-5753 Update C48281 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition Any defined stage in the lifecycle of a clinical trial. A step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] 2022-09-30 CDISC-5753 Update C48281 CDISC Synonym Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Add new CDISC Synonym - - - Trial Phase 2022-09-30 CDISC-5753 Update C85826 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition The principal purpose of the trial. A principle objective of the study. 2022-09-30 CDISC-5753 Update C85826 CDISC Synonym Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Add new CDISC Synonym - - - Study Primary Objective 2022-09-30 CDISC-5753 Update C85827 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition The auxiliary purpose of the trial. An auxiliary objective of the study. 2022-09-30 CDISC-5753 Update C85827 CDISC Synonym Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Add new CDISC Synonym - - - Study Secondary Objective