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¨ Obs |
· VERSION |
· DOMAIN |
¨ SEQUENCE |
· VARIABLE |
· LABEL |
· TYPE |
· CT_OR_FORMAT |
· ROLE |
· CDISC_NOTES |
· CORE |
· CLASS |
· VARIABLE_WO_PREFIX |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SDTMIG 3.4 (Public Review) | TA | 1 | STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | Trial Design | STUDYID | |
| 2 | SDTMIG 3.4 (Public Review) | TA | 2 | DOMAIN | Domain Abbreviation | Char | TA | Identifier | Two-character abbreviation for the domain. | Req | Trial Design | DOMAIN |
| 3 | SDTMIG 3.4 (Public Review) | TA | 3 | ARMCD | Planned Arm Code | Char | Topic | ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than that for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. | Req | Trial Design | ARMCD | |
| 4 | SDTMIG 3.4 (Public Review) | TA | 4 | ARM | Description of Planned Arm | Char | Synonym Qualifier | Name given to an Arm or treatment group. | Req | Trial Design | ARM | |
| 5 | SDTMIG 3.4 (Public Review) | TA | 5 | TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the order of the Element within the Arm. | Req | Trial Design | ETORD | |
| 6 | SDTMIG 3.4 (Public Review) | TA | 6 | ETCD | Element Code | Char | Record Qualifier | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. | Req | Trial Design | ETCD | |
| 7 | SDTMIG 3.4 (Public Review) | TA | 7 | ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element. The same Element may occur more than once within an Arm. | Perm | Trial Design | ELEMENT | |
| 8 | SDTMIG 3.4 (Public Review) | TA | 8 | TABRANCH | Branch | Char | Rule | Condition subject met, at a "branch" in the trial design at the end of this Element, to be included in this Arm (e.g., "Randomization to DRUG X"). | Exp | Trial Design | BRANCH | |
| 9 | SDTMIG 3.4 (Public Review) | TA | 9 | TATRANS | Transition Rule | Char | Rule | If the trial design allows a subject to transition to an Element other than the next Element in sequence, then the conditions for transitioning to those other Elements, and the alternative Element sequences, are specified in this rule (e.g., "Responders go to washout"). | Exp | Trial Design | TRANS | |
| 10 | SDTMIG 3.4 (Public Review) | TA | 10 | EPOCH | Epoch | Char | (EPOCH) | Timing | Name of the Trial Epoch with which this Element of the Arm is associated. | Req | Trial Design | EPOCH |
| Copyright @ www.mycsg.in |
¨ Obs |
· CODELIST_VERSION |
· CODELIST_ABBREVIATION |
· CDISC_SUBMISSION_VALUE |
· APPLICABLE |
· CRF_VALUE |
¨ NUMERIC_VALUE |
· TFL_VALUE |
· CODELIST_CODE |
· CODELIST_NAME |
· CODELIST_EXTENSIBLE |
· NCI_CODELIST_LABEL |
· CDISC_DEFINITION |
· CDISC_SYNONYM_S_ |
· CODE |
· NCI_PREFERRED_TERM |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2020-03-27 | EPOCH | BASELINE | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study after eligibility has been met and before the start of treatment, at which baseline measurements are collected. | C125938 | Baseline Epoch | ||||
| 2 | 2020-03-27 | EPOCH | BLINDED TREATMENT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects receive blinded therapeutic treatment. | C102255 | Blinded Treatment Epoch | ||||
| 3 | 2020-03-27 | EPOCH | CONTINUATION TREATMENT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects receive continuation treatment. | Continuation Phase | C123452 | Continuation Therapy Epoch | |||
| 4 | 2020-03-27 | EPOCH | FOLLOW-UP | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. | C99158 | Clinical Study Follow-up | ||||
| 5 | 2020-03-27 | EPOCH | INDUCTION TREATMENT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects receive induction treatment. | Induction Phase; Intensive Phase | C123453 | Induction Therapy Epoch | |||
| 6 | 2020-03-27 | EPOCH | LONG-TERM FOLLOW-UP | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which information about the health status of an individual is obtained long after study interventions have concluded. | C16032 | Long-term Follow-up | ||||
| 7 | 2020-03-27 | EPOCH | OBSERVATION | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects are observed, without any planned intervention. | C165873 | Observation Study Epoch | ||||
| 8 | 2020-03-27 | EPOCH | OPEN LABEL TREATMENT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects receive open label therapeutic treatment. | C102256 | Open Label Treatment Epoch | ||||
| 9 | 2020-03-27 | EPOCH | RUN-IN | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason. | C98779 | Run-in Period | ||||
| 10 | 2020-03-27 | EPOCH | SCREENING | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects are evaluated for participation in the study. | C48262 | Trial Screening | ||||
| 11 | 2020-03-27 | EPOCH | TREATMENT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period in a clinical study during which subjects receive investigational product. | C101526 | Treatment Epoch | ||||
| 12 | 2020-03-27 | EPOCH | WASHOUT | . | C99079 | Epoch | Yes | CDISC SDTM Epoch Terminology | A period of time during a clinical study when a participant is taken off of a study drug or other medication in order to eliminate the effects of the treatment. | C42872 | Washout Period |
| Copyright @ www.mycsg.in |
¨ Obs |
· CODELIST_VERSION |
· SCODELIST_ABBREVIATION |
· CODELIST_TYPE |
· CODE |
· DECOD |
· APPLICABLE |
· CRF_VALUE |
¨ NUMERIC_VALUE |
· TFL_VALUE |
· VALUE_CODE |
· SCODELIST_CODE |
· LCODELIST_CODE |
· SCODELIST_EXTENSIBLE |
· LCODELIST_EXTENSIBLE |
· SCODELIST_NAME |
· LCODELIST_ABBREVIATION |
· LCODELIST_NAME |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2020-03-27 | EPOCH | Single | BASELINE | . | C125938 | C99079 | Yes | Epoch | ||||||||
| 2 | 2020-03-27 | EPOCH | Single | BLINDED TREATMENT | . | C102255 | C99079 | Yes | Epoch | ||||||||
| 3 | 2020-03-27 | EPOCH | Single | CONTINUATION TREATMENT | . | C123452 | C99079 | Yes | Epoch | ||||||||
| 4 | 2020-03-27 | EPOCH | Single | FOLLOW-UP | . | C99158 | C99079 | Yes | Epoch | ||||||||
| 5 | 2020-03-27 | EPOCH | Single | INDUCTION TREATMENT | . | C123453 | C99079 | Yes | Epoch | ||||||||
| 6 | 2020-03-27 | EPOCH | Single | LONG-TERM FOLLOW-UP | . | C16032 | C99079 | Yes | Epoch | ||||||||
| 7 | 2020-03-27 | EPOCH | Single | OBSERVATION | . | C165873 | C99079 | Yes | Epoch | ||||||||
| 8 | 2020-03-27 | EPOCH | Single | OPEN LABEL TREATMENT | . | C102256 | C99079 | Yes | Epoch | ||||||||
| 9 | 2020-03-27 | EPOCH | Single | RUN-IN | . | C98779 | C99079 | Yes | Epoch | ||||||||
| 10 | 2020-03-27 | EPOCH | Single | SCREENING | . | C48262 | C99079 | Yes | Epoch | ||||||||
| 11 | 2020-03-27 | EPOCH | Single | TREATMENT | . | C101526 | C99079 | Yes | Epoch | ||||||||
| 12 | 2020-03-27 | EPOCH | Single | WASHOUT | . | C42872 | C99079 | Yes | Epoch |