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 2019-09-27 CDISC-4027 Update C93682 CDISC Definition Clinical Study Attribute Terminology Clinical Study Attribute Terminology Update CDISC Definition A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a subject could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. 2019-09-27 CDISC-4027 Update C139170 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition The country in which subjects are located when enrolling in a trial or study. (NCI) The country in which participants are located when enrolling in a trial or study. 2019-09-27 CDISC-4027 Update C147068 CDISC Codelist Name Participant Allocation Response Participant Allocation Response Update CDISC Codelist Name Subject Allocation Response Participant Allocation Response 2019-09-27 CDISC-4027 Update C147068 CDISC Submission Value Participant Allocation Response Participant Allocation Response Update CDISC Submission Value Subject Allocation Response Participant Allocation Response 2019-09-27 CDISC-4027 Update C147068 CDISC Definition Participant Allocation Response Participant Allocation Response Update CDISC Definition A terminology codelist for the method of assigning subjects to groups or categories within a clinical study. A terminology codelist for the method of assigning participants, or subjects, to groups or categories within a clinical study. 2019-09-27 CDISC-4027 Update C147068 CDISC Synonym Participant Allocation Response Participant Allocation Response Add new CDISC Synonym - - - Participant Allocation Response 2019-09-27 CDISC-4027 Update C147068 CDISC Synonym Participant Allocation Response Participant Allocation Response Remove CDISC Synonym Subject Allocation Response - - - 2019-09-27 CDISC-4027 Update C25196 CDISC Codelist Name Participant Allocation Response Participant Allocation Response Update CDISC Codelist Name Subject Allocation Response Participant Allocation Response 2019-09-27 CDISC-4027 Update C48660 CDISC Codelist Name Participant Allocation Response Participant Allocation Response Update CDISC Codelist Name Subject Allocation Response Participant Allocation Response 2019-09-27 CDISC-4027 Update C93043 CDISC Codelist Name Participant Allocation Response Participant Allocation Response Update CDISC Codelist Name Subject Allocation Response Participant Allocation Response 2019-09-27 CDISC-4027 Add C142707 Term Protocol Entity Terminology Protocol Entity Terminology Add new term to existing codelist - - - Study Monitoring 2019-09-27 CDISC-4027 Update C142743 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of randomization schema in which unequal numbers of subjects are purposely assigned to multiple treatment groups. A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups. 2019-09-27 CDISC-4027 Update C147126 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of randomization schema in which the group assignment probability of a subject is adjusted based on the group assignments of those subjects already randomized in the trial. (NCI) A type of randomization schema in which the group assignment probability of a participant is adjusted based on the group assignments of those participants already randomized in the trial. 2019-09-27 CDISC-4027 Update C147127 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of adaptive randomization in which a pre-specified number of subjects is assigned to a block containing the same pre-specified number of balanced group assignments in random order. A type of adaptive randomization in which a pre-specified number of participants is assigned to a block containing the same pre-specified number of balanced group assignments in random order. 2019-09-27 CDISC-4027 Update C147143 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of adaptive randomization in which the subject is assigned to the treatment group in an attempt to minimize imbalances in the number of subjects for each stratification covariate across treatment groups. A type of adaptive randomization in which the participant is assigned to the treatment group in an attempt to minimize imbalances in the number of participants for each stratification covariate across treatment groups. 2019-09-27 CDISC-4027 Update C147144 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of randomization schema in which each subject has the same chance of being randomized into any one group as all other subjects. (NCI) A type of randomization schema in which each participant has the same chance of being randomized into any one group as all other participants. 2019-09-27 CDISC-4027 Update C147145 CDISC Definition Randomization Type Response Randomization Type Response Update CDISC Definition A type of block randomization in which subjects are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. (NCI) A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. 2019-09-27 CDISC-4027 Update C147140 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition The type of randomization method used to assign subjects to treatment groups or cohorts. (NCI) The type of randomization method used to assign particpants to treatment groups or cohorts. 2019-09-27 CDISC-4027 Update C49692 CDISC Submission Value Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Submission Value Planned Number of Subjects Planned Number of Participants 2019-09-27 CDISC-4027 Update C52580 CDISC Submission Value Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Submission Value Subject Allocation Participant Allocation 2019-09-27 CDISC-4027 Update C52580 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition The process of assigning subjects to particular treatment groups or cohorts in a clinical study. The process of assigning participants to particular treatment groups or cohorts in a clinical study. 2019-09-27 CDISC-4027 Update C52580 CDISC Synonym Study Design Attribute Terminology Study Design Attribute Terminology Add new CDISC Synonym - - - Subject Allocation 2019-09-27 CDISC-4027 Add C115753 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Clinical Monitoring Plan 2019-09-27 CDISC-4027 Add C142488 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Data Monitoring 2019-09-27 CDISC-4027 Add C142674 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Risk Monitoring 2019-09-27 CDISC-4027 Add C15789 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Trial Monitoring 2019-09-27 CDISC-4027 Add C163026 CDISC Codelist Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Addition of new codelist - - - Study Monitoring Attribute Terminology 2019-09-27 CDISC-4027 Add C163406 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Data and Safety Monitoring Plan 2019-09-27 CDISC-4027 Add C163407 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - GCP Adherence Statement 2019-09-27 CDISC-4027 Add C163408 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Safety Data Monitoring 2019-09-27 CDISC-4027 Add C163409 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Safety Monitoring 2019-09-27 CDISC-4027 Add C163410 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Study Monitoring Statement 2019-09-27 CDISC-4027 Add C163411 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to new codelist - - - Suicidal Risk Monitoring 2019-09-27 CDISC-4027 Update C15843 CDISC Synonym Study Purpose Response Study Purpose Response Add new CDISC Synonym - - - Prophylaxis