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164 changes: 78 additions & 86 deletions Published/CORE-000212/rule.yml
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# Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT'
# Rule: DSSCAT must be present
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either
disposition of study participation or of a study
treatment. It describes whether a subject completed study
participation or a study treatment, and if not, the reason
they did not complete it. Dispositions may be described for
each Epoch (e.g., screening, initial treatment, washout,
cross-over treatment, follow-up) or for the study as a whole.
If disposition events for both study participation and study
treatment(s) are to be represented, then DSSCAT provides this
distinction. The value of DSSCAT is based on the sponsor's
controlled terminology, however for records with DSCAT =
"DISPOSITION EVENT", DSSCAT = "STUDY PARTICIPATION" is used to
represent disposition of study participation. DSSCAT = "STUDY
TREATMENT" can be used as a generic identifier when a study
has only a single treatment. If a study has multiple
treatments, then DSSCAT should name the individual treatment.
Document: IG v3.4
Item: DS – Assumption 2b
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
Version: '1'
Version: '2.0'
Version: '3.4'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: If separate disposition events for both study participation and
study treatment(s) are to be represented, then DSSCAT provides
this distinction.
Document: IG v3.3
Item: Assumption 2.b
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
Version: '1'
Version: '2.0'
Version: '3.3'
- Name: TIG
References:
- Citations:
- Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either
disposition of study participation or of a product exposure.
It describes whether a subject completed study participation
or a product exposure and, if not, the reason they did not
complete it. Dispositions may be described for each epoch
(e.g., screening, initial exposure, washout, cross-over,
follow-up) or for the study as a whole. If disposition events
for both study participation and product exposure(s) are to be
represented, then DSSCAT provides this distinction.
Document: TIG 1.0
Item: Assumption 2b
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0628
Version: '1'
Version: '1.0'
Substandard: SDTM
Version: '1.0'
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of
study participation or of a study treatment. It describes whether a subject completed
study participation or a study treatment, and if not, the reason they did not complete it.
Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout,
cross-over treatment, follow-up) or for the study as a whole. If disposition events for
both study participation and study treatment(s) are to be represented, then DSSCAT
provides this distinction. The value of DSSCAT is based on the sponsor's controlled
terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY
PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY
TREATMENT" can be used as a generic identifier when a study has only a single treatment.
If a study has multiple treatments, then DSSCAT should name the individual treatment.
Document: IG v3.4
Item: DS – Assumption 2b
Section: 6.2.3
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
Version: "1"
Version: "2.0"
Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: If separate disposition events for both study participation and study
treatment(s) are to be represented, then DSSCAT provides this distinction.
Document: IG v3.3
Item: Assumption 2.b
Section: 6.2.3 DS
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0535
Version: "1"
Version: "2.0"
Version: "3.3"
- Name: TIG
References:
- Citations:
- Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of
study participation or of a product exposure. It describes whether a subject completed
study participation or a product exposure and, if not, the reason they did not complete
it. Dispositions may be described for each epoch (e.g., screening, initial exposure,
washout, cross-over, follow-up) or for the study as a whole. If disposition events for
both study participation and product exposure(s) are to be represented, then DSSCAT
provides this distinction.
Document: TIG 1.0
Item: Assumption 2b
Section: 2.8.10.8
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0628
Version: "1"
Version: "1.0"
Substandard: SDTM
Version: "1.0"
Check:
all:
- name: DSCAT
operator: is_not_unique_set
value:
- USUBJID
- EPOCH
- name: DSCAT
operator: equal_to
value: DISPOSITION EVENT
- name: DSSCAT
operator: not_exists
- name: DSCAT
operator: is_not_unique_set
value:
- USUBJID
- EPOCH
- name: DSCAT
operator: equal_to
value: DISPOSITION EVENT
- name: DSSCAT
operator: not_exists
Core:
Id: CORE-000212
Status: Published
Version: '1'
Description: When subject has more than one record per Epoch with DSCAT =
DISPOSITION EVENT, DSSCAT must be present.
Version: "1"
Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT
must be present.
Executability: Fully Executable
Outcome:
Message: DSSCAT is not present when subject has more than one record per Epoch
with DSCAT = 'DISPOSITION EVENT'.
Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT =
'DISPOSITION EVENT'.
Output Variables:
- USUBJID
- USUBJID
Rule Type: Record Data
Scope:
Classes:
Include:
- EVENTS
- EVENTS
Domains:
Include:
- DS
- DS
Use Case: INDH
Sensitivity: Dataset
Sensitivity: Record
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