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 2022-06-24 CDISC-5529 Add C187682 CDISC Codelist Expanded Access Attribute Terminology Expanded Access Attribute Terminology Addition of new codelist - - - Expanded Access Attribute Terminology 2022-06-24 CDISC-5529 Add C187705 Term Expanded Access Attribute Terminology Expanded Access Attribute Terminology Add new term to new codelist - - - Expanded Access Study Type 2022-06-24 CDISC-5529 Add C182399 Term Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology Add new term to new codelist - - - Individual Patient IND 2022-06-24 CDISC-5529 Add C187683 CDISC Codelist Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology Addition of new codelist - - - Expanded Access Study Type Value Set Terminology 2022-06-24 CDISC-5529 Add C187706 Term Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology Add new term to new codelist - - - Continued Access 2022-06-24 CDISC-5529 Add C187707 Term Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology Add new term to new codelist - - - Treatment IND 2022-06-24 CDISC-5529 Add C98722 Term Protocol Entity Terminology Protocol Entity Terminology Add new term to existing codelist - - - Expanded Access 2022-06-24 CDISC-5529 Update C49658 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition The type of experimental design used to describe the level of awareness of the clinical trial subjects and/or investigators of the intervention(s) that they are receiving and/or administering. The type of experimental design used to describe the level of awareness of the study subjects and/ or study personnel as it relates to the respective intervention(s) or assessments being observed, received or administered. 2022-06-24 CDISC-5529 Update C49658 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Study Blinding Design 2022-06-24 CDISC-5529 Update C49658 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Study Blinding Schema 2022-06-24 CDISC-5529 Update C49658 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Study Masking Design 2022-06-24 CDISC-5529 Update C49658 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Trial Blinding Design 2022-06-24 CDISC-5529 Update C49658 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Trial Masking Design 2022-06-24 CDISC-5529 Update C176342 CDISC Synonym Study Subject Discontinuation Attribute Terminology Study Subject Discontinuation Attribute Terminology Add new CDISC Synonym - - - Informed Consent Withdrawn 2022-06-24 CDISC-5529 Update C98722 CDISC Definition STYPE Study Type Response Update CDISC Definition Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access. Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. 2022-06-24 CDISC-5529 Update C98722 CDISC Synonym STYPE Study Type Response Add new CDISC Synonym - - - Compassionate Use