diff --git a/Published/CORE-000217/negative/05/data/.env b/Published/CORE-000217/negative/05/data/.env index 44425e178..8f9bf60aa 100644 --- a/Published/CORE-000217/negative/05/data/.env +++ b/Published/CORE-000217/negative/05/data/.env @@ -1,2 +1,2 @@ -PRODUCT=sendig -VERSION=3-1 +PRODUCT=SDTMIG +VERSION=3-4 diff --git a/Published/CORE-000217/negative/05/data/_datasets.csv b/Published/CORE-000217/negative/05/data/_datasets.csv index 6034e4ece..eb8751327 100644 --- a/Published/CORE-000217/negative/05/data/_datasets.csv +++ b/Published/CORE-000217/negative/05/data/_datasets.csv @@ -1,2 +1,2 @@ Filename,Label -te,Trial Elements +ec,Exposure as Collected diff --git a/Published/CORE-000217/negative/05/data/_variables.csv b/Published/CORE-000217/negative/05/data/_variables.csv index 8bf535087..a3618c09a 100644 --- a/Published/CORE-000217/negative/05/data/_variables.csv +++ b/Published/CORE-000217/negative/05/data/_variables.csv @@ -1,8 +1,23 @@ dataset,variable,label,type,length -te,STUDYID,Study Identifier,Char,12 -te,DOMAIN,Domain Abbreviation,Char,2 -te,ETCD,Element Code,Char,7 -te,ELEMENT,Description of Element,Char,26 -te,TESTRL,Rule for Start of Element,Char,200 -te,TEENRL,Rule for End of Element,Char,200 -te,TEDUR,Planned Duration of Element,Char,50 +ec,STUDYID,Study Identifier,Char,50 +ec,DOMAIN,Domain Abbreviation,Char,50 +ec,USUBJID,Unique Subject Identifier,Char,50 +ec,SPDEVID,Sponsor Device Identifier,Char,200 +ec,ECSEQ,Sequence Number,Num,8 +ec,ECTRT,Name of Treatment,Char,50 +ec,ECPRESP,Pre-Specified,Char,50 +ec,ECOCCUR,Occurrence,Char,50 +ec,ECDOSE,Dose,Num,8 +ec,ECDOSU,Dose Units,Char,50 +ec,ECDOSFRM,Dose Form,Char,50 +ec,ECDOSFRQ,Dosing Frequency per Interval,Char,50 +ec,ECROUTE,Route of Administration,Char,50 +ec,ECLOT,Lot Number,Char,50 +ec,ECPSTRG,Pharmaceutical Strength,Num,8 +ec,ECPSTRGU,Pharmaceutical Strength Units,Char,50 +ec,ECSTAT,Completion Status,Char,50 +ec,EPOCH,Epoch,Char,50 +ec,ECSTDTC,Start Date/Time of Treatment,Char,50 +ec,ECENDTC,End Date/Time of Treatment,Char,50 +ec,ECSTDY,Study Day of Start of Treatment,Num,8 +ec,ECENDY,Study Day of End of Treatment,Num,8 diff --git a/Published/CORE-000217/negative/05/data/ec.csv b/Published/CORE-000217/negative/05/data/ec.csv new file mode 100644 index 000000000..40255b2b9 --- /dev/null +++ b/Published/CORE-000217/negative/05/data/ec.csv @@ -0,0 +1,3 @@ +STUDYID,DOMAIN,USUBJID,SPDEVID,ECSEQ,ECTRT,ECPRESP,ECOCCUR,ECDOSE,ECDOSU,ECDOSFRM,ECDOSFRQ,ECROUTE,ECLOT,ECPSTRG,ECPSTRGU,ECSTAT,EPOCH,ECSTDTC,ECENDTC,ECSTDY,ECENDY +CDISCPILOT01,EC,CDISC001,DEV0001,1,ZANOMALINE,Y,Y,,,INJECTION,QD,SUBCUTANEOUS,SDS580-359,10.8,g/L,,TREATMENT,2012-11-30,2012-11-30,1,1 +CDISCPILOT01,EC,CDISC002,DEV0002,2,ZANOMALINE,Y,,,,INJECTION,QD,SUBCUTANEOUS,SDS580-360,11.8,g/L,,TREATMENT,2012-11-30,2012-11-30,1,1 diff --git a/Published/CORE-000217/negative/05/data/te.csv b/Published/CORE-000217/negative/05/data/te.csv deleted file mode 100644 index 051eb9475..000000000 --- a/Published/CORE-000217/negative/05/data/te.csv +++ /dev/null @@ -1,3 +0,0 @@ -STUDYID,DOMAIN,ETCD,ELEMENT,TESTRL,TEENRL,TEDUR -CDISCPILOT01,TE,SCREEN,Screening,Date of informed consent,, -CDISCPILOT01,TE,PLACEBO,Placebo,First dose when drug is Placebo,26 weeks after the start of the Element,26 diff --git a/Published/CORE-000217/negative/05/results/results.csv b/Published/CORE-000217/negative/05/results/results.csv index 04c7065d3..0acef2eaa 100644 --- a/Published/CORE-000217/negative/05/results/results.csv +++ b/Published/CORE-000217/negative/05/results/results.csv @@ -1,3 +1,9 @@ Dataset,Record,Variable,Value -TE,1,TEDUR, -TE,1,TEENRL, +EC,1,ECDOSE, +EC,1,ECDOSTXT,Not in dataset +EC,1,ECOCCUR,Y +EC,1,ECSTAT, +EC,2,ECDOSE, +EC,2,ECDOSTXT,Not in dataset +EC,2,ECOCCUR, +EC,2,ECSTAT, diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml index 79c2a524b..708fa52a8 100644 --- a/Published/CORE-000217/rule.yml +++ b/Published/CORE-000217/rule.yml @@ -2,165 +2,193 @@ # Condition: ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT = null # Rule: ECDOSTXT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.4 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.3 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.2 - Item: Assumption 4a|Assumption 4b - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: TIG 1.0 - Item: Assumption 4a|4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0592 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.4 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.3 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.2 + Item: Assumption 4a|Assumption 4b + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: TIG 1.0 + Item: Assumption 4a|4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0592 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: not_exists + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: not_exists + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: not_exists + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: not_exists Core: Id: CORE-000217 Status: Published - Version: '1' -Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', - ECSTAT is empty and ECDOSTXT is empty + Version: "1" +Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and + ECDOSTXT is empty Executability: Fully Executable Outcome: - Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but - ECDOSTXT is also empty. + Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also + empty. Output Variables: - - ECDOSE - - ECOCCUR - - ECSTAT - - ECDOSTXT + - ECDOSE + - ECOCCUR + - ECSTAT + - ECDOSTXT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record