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Initial Rules and Data #2

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2 changes: 0 additions & 2 deletions README.md
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95 changes: 95 additions & 0 deletions Rules/Published/CORE-000001/CORE-000001.yml
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# Variable: IEORRES
# Condition: IECAT = 'INCLUSION'
# Rule: IEORRES = 'N'
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The intent of the domain model is to collect responses to only
those criteria that the subject did not meet, and not the
responses to all criteria.
Document: SDTM v3.4
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
Version: '1'
Version: '2.0'
Version: '3.4'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The intent of the domain model is to collect response to only
those criteria that the subject did not meet, and not the
responses to all criteria.
Document: IG v3.2
Item: Assumption 2
Section: '6.3'
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
Version: '1'
Version: '2.0'
Version: '3.2'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: The intent of the domain model is to collect response to only
those criteria that the subject did not meet, and not the
responses to all criteria.
Document: IG v3.3
Item: Assumption 1
Section: 6.3.4
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0176
Version: '1'
Version: '2.0'
Version: '3.3'
- Name: TIG
References:
- Citations:
- Cited Guidance: The intent of the domain model is to collect responses to only
those criteria that the subject did not meet, and not the
responses to all criteria.
Document: TIG 1.0
Item: Assumption 1
Section: '2.8.10.13'
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0405
Version: '1'
Version: '1.0'
Substandard: SDTM
Version: '1.0'
Check:
all:
- name: IECAT
operator: equal_to
value: INCLUSION
value_is_literal: true
- name: IEORRES
operator: not_equal_to
value: N
value_is_literal: true
Core:
Id: CORE-000001
Status: Published
Version: '1'
Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is
not equal to 'N'.
Executability: Fully Executable
Outcome:
Message: IEORRES is not equal to 'N' when IECAT equals 'INCLUSION'.
Rule Type: Record Data
Scope:
Classes:
Include:
- FINDINGS
Domains:
Include:
- IE
Use Case: INDH
Sensitivity: Record
86 changes: 86 additions & 0 deletions Rules/Published/CORE-000002/CORE-000002.yml
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# Variable: SESTDTC
# Condition:
# Rule: SESTDTC ^= null
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
Version: '3.4'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
Version: '3'
Version: '2.0'
Citations:
- Cited Guidance: Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
a particular Element, then there must be some information on when
it started, even if that information is imprecise. Thus, SESTDTC
may not be null, although some records may not have all the components
(e.g., year, month, day, hour, minute) of the date/time value collected.
Document: SDTM v1.4
Section: '5.3'
- Name: SDTMIG
Version: '3.2'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
Version: '3'
Version: '2.0'
Citations:
- Cited Guidance: Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
a particular Element, then there must be some information on when
it started, even if that information is imprecise. Thus, SESTDTC
may not be null, although some records may not have all the components
(e.g., year, month, day, hour, minute) of the date/time value collected.
Document: IG v3.2
Item: Assumption 11
Section: 5 SE
- Name: SDTMIG
Version: '3.3'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0208
Version: '3'
Version: '2.0'
Citations:
- Cited Guidance: Note that SESTDTC is required, although --STDTC is
not required in any other subject-level dataset. The purpose of
the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through
a particular Element, then there must be some information on when
it started, even if that information is imprecise. Thus, SESTDTC
may not be null, although some records may not have all the components
(e.g., year, month, day, hour, minute) of the date/time value collected.
Document: IG v3.3
Item: Assumption 9
Section: '5.3'
Check:
all:
- name: SESTDTC
operator: empty
Core:
Id: CORE-000002
Status: Published
Version: '1'
Description: Raise an error when SESTDTC is null.
Executability: Fully Executable
Outcome:
Message: SESTDTC is required.
Rule Type: Record Data
Scope:
Classes:
Include:
- SPECIAL PURPOSE
Domains:
Include:
- SE
Sensitivity: Record
77 changes: 77 additions & 0 deletions Rules/Published/CORE-000003/CORE-000003.yml
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# Variable: TRLOC
# Condition:
# Rule: TRLOC not present in dataset
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
Version: '3.4'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: The TR domain does not include anatomical location
information on each measurement/assessment record, because this
would be a duplication of information already represented in TU.
The multi-domain approach to representing oncology assessment data
was developed largely to reduce duplication of stored information.
Document: SDTM v3.4
Section: 6.3.12.2
- Name: SDTMIG
Version: '3.2'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.2
Item: Specification
Section: '6.3'
- Name: SDTMIG
Version: '3.3'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0299
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: The TR domain does not include anatomical location
information on each measurement record because this would be a duplication
of information already represented in TU. This duplication of data
was a deciding factor in multi-domain approach to representing this
data.
Document: IG v3.3
Item: Specification
Section: 6.3.16.2
Check:
all:
- name: TRLOC
operator: exists
Core:
Id: CORE-000003
Status: Published
Version: '1'
Description: Raise an error when TRLOC is present.
Executability: Fully Executable
Outcome:
Message: TRLOC is present when TRLOC is not included in the TR domain.
Rule Type: Record Data
Scope:
Classes:
Include:
- FINDINGS
Domains:
Include:
- TR
Sensitivity: Dataset
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