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2 changes: 2 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/.env
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PRODUCT=SDTMIG
VERSION=3-4
3 changes: 3 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/_datasets.csv
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Filename,Label
cm,Concomitant/Prior Medications
mh, Medical History
30 changes: 30 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/_variables.csv
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dataset,variable,label,type,length
cm,STUDYID,Study Identifier,Char,12
cm,DOMAIN,Domain Abbreviation,Char,2
cm,USUBJID,Unique Subject Identifier,Char,8
cm,CMSEQ,Sequence Number,Num,8
cm,CMTRT,"Reported Name of Drug, Med, or Therapy",Char,200
cm,CMINDC,Indication,Char,200
cm,CMDOSE,Dose per Administration,Num,8
cm,CMDOSU,Dose Units,Char,6
cm,CMDOSFRQ,Dosing Frequency per Interval,Char,3
cm,CMROUTE,Route of Administration,Char,24
cm,EPOCH,Epoch,Char,9
cm,CMSTDTC,Start Date/Time of Medication,Char,10
cm,CMENDTC,End Date/Time of Medication,Char,10
cm,CMSTDY,Study Day of Start of Medication,Num,8
cm,CMENDY,Study Day of End of Medication,Num,8
cm,CMENRTPT,End Relative to Reference Time Point,Char,7
cm,CMENTPT,End Reference Time Point,Char,10
mh,STUDYID,Study Identifier,Char,12
mh,DOMAIN,Domain Abbreviation,Char,2
mh,USUBJID,Unique Subject Identifier,Char,8
mh,MHSEQ,Sequence Number,Num,8
mh,MHTERM,Reported Term for the Medical History,Char,19
mh,MHEVDTYP,Medical History Event Date Type,Char,13
mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10
mh,MHSTDY,Study Day of Start of Observation,Num,8
mh,MHENDTC,End Date/Time of Medical History Event,Char,50
mh,MHENDY,Study Day of End of Observation,Num,8
mh,MHENRTPT,End Relative to Reference Time Point,Char,50
mh,MHENTPT,End Reference Time Point,Char,50
6 changes: 6 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/cm.csv
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STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT
CDISCPILOT01,CM,CDISC005,1,CENTRUM SILVER,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2012-03,,,,,2013-08-06
CDISCPILOT01,CM,CDISC005,4,HYDROCORTISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,TREATMENT,2013-05-14,,100,,,2013-08-06
CDISCPILOT01,CM,CDISC017,1,ACETAMINOPHEN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2008,,,,,2014-03-08
CDISCPILOT01,CM,CDISC017,2,MULTIVITAMIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2011-08,,,,,2014-03-08
CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,,2014-03-08
5 changes: 5 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/mh.csv
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STUDYID,DOMAIN,USUBJID,MHSEQ,MHTERM,MHEVDTYP,MHSTDTC,MHSTDY,MHENDTC,MHENDY,MHENRTPT,MHENTPT
CDISCPILOT01,MH,CDISC001,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2004-05-28,-3108,,,,2021-05-01
CDISCPILOT01,MH,CDISC002,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-03-19,-972,2010-03-21,-970,,2021-02-15
CDISCPILOT01,MH,CDISC003,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2007-02-09,-2393,2007-02-09,-2393,,2015-05-09
CDISCPILOT01,MH,CDISC004,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-11-05,-1068,,,,2011-06-11
19 changes: 19 additions & 0 deletions Unpublished/NEW-RULE/negative/01/results/results.csv
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Dataset,Record,Variable,Value
CM,1,CMENTPT,2013-08-06
CM,1,CMENRTPT,null
CM,2,CMENTPT,2013-08-06
CM,2,CMENRTPT,null
CM,3,CMENTPT,2014-03-08
CM,3,CMENRTPT,null
CM,4,CMENTPT,2014-03-08
CM,4,CMENRTPT,null
CM,5,CMENTPT,2014-03-08
CM,5,CMENRTPT,null
MH,1,MHENTPT,2021-05-01
MH,1,MHENRTPT,null
MH,2,MHENTPT,2021-02-15
MH,2,MHENRTPT,null
MH,3,MHENTPT,2015-05-09
MH,3,MHENRTPT,null
MH,4,MHENTPT,2011-06-11
MH,4,MHENRTPT,null
32 changes: 32 additions & 0 deletions Unpublished/NEW-RULE/negative/01/results/results_engine.log.txt
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[INFO 2026-07-03 13:06:31,758 - console_logger.py:44] - Populating cache, cache path: C:\Users\els_janssens\CORE\Rule_Authoring_CDISC_training\cdisc-open-rules-training\engine\resources\cache
[INFO 2026-07-03 13:06:31,759 - console_logger.py:44] - No rules specified with -r or -er rules flags. Validating with rules in local directory
[INFO 2026-07-03 13:06:32,071 - console_logger.py:44] - Using PANDAS dataset implementation
[INFO 2026-07-03 13:06:32,088 - console_logger.py:44] - Running 1 rules against 2 datasets
[INFO 2026-07-03 13:06:39,575 - console_logger.py:44] - Using PANDAS dataset implementation
[INFO 2026-07-03 13:06:39,575 - console_logger.py:44] - Using PANDAS dataset implementation
[INFO 2026-07-03 13:06:39,605 - console_logger.py:44] - Validating CM. rule={'core_id': 'CG0045', 'author': 'CDISC', 'reference': [[{'Citations': [{'Cited_Guidance': 'The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. This is the sponsor-defined reference point referred to by --ENRTPT.', 'Document': 'Model v2.0', 'Item': '--ENTPT', 'Section': 'Timing'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], [{'Citations': [{'Cited_Guidance': 'Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.7', 'Item': 'Table 2.2.5.1: --ENRTPT', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], [{'Citations': [{'Cited_Guidance': '(--ENRTPT) Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.4', 'Item': 'Specification', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}]], 'sensitivity': 'Record', 'executability': 'fully executable', 'description': 'Raise an error when --ENTPT is populated but --ENRTPT is not populated.', 'authorities': [{'Organization': 'CDISC', 'Standards': [{'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': 'The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. This is the sponsor-defined reference point referred to by --ENRTPT.', 'Document': 'Model v2.0', 'Item': '--ENTPT', 'Section': 'Timing'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.4'}, {'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': 'Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.7', 'Item': 'Table 2.2.5.1: --ENRTPT', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.3'}, {'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': '(--ENRTPT) Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.4', 'Item': 'Specification', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.2'}]}], 'standards': [{'Name': 'SDTMIG', 'Version': '3.4', 'Substandard': None}, {'Name': 'SDTMIG', 'Version': '3.3', 'Substandard': None}, {'Name': 'SDTMIG', 'Version': '3.2', 'Substandard': None}], 'classes': {'Include': ['ALL']}, 'domains': {'Include': ['ALL']}, 'entities': None, 'rule_type': 'Record Data', 'conditions': <cdisc_rules_engine.models.rule_conditions.condition_composite.ConditionComposite object at 0x000001F800106CC0>, 'actions': [{'name': 'generate_dataset_error_objects', 'params': {'message': '--ENRTPT is not populated when --ENTPT is populated.'}}], 'use_case': None, 'data_structures': None, 'status': 'Draft', 'output_variables': ['--ENTPT', '--ENRTPT']}. dataset_path=C:\Users\els_janssens\CORE\Rule_Authoring_CDISC_training\cdisc-open-rules-training\Unpublished\NEW-RULE\negative\01\data\cm.csv. datasets=[SDTMDatasetMetadata(name='CM', label='Concomitant/Prior Medications', filename='cm.csv', file_size=751, record_count=5, modification_date='2026-07-03T13:03:20.750712', full_path='C:\\Users\\els_janssens\\CORE\\Rule_Authoring_CDISC_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data\\cm.csv', first_record={'STUDYID': 'CDISCPILOT01', 'DOMAIN': 'CM', 'USUBJID': 'CDISC005', 'CMSEQ': '1', 'CMTRT': 'CENTRUM SILVER', 'CMINDC': 'PROPHYLAXIS OR NON-THERAPEUTIC USE', 'CMDOSE': '1', 'CMDOSU': 'TABLET', 'CMDOSFRQ': '', 'CMROUTE': 'ORAL', 'EPOCH': 'SCREENING', 'CMSTDTC': '2012-03', 'CMENDTC': '', 'CMSTDY': '', 'CMENDY': '', 'CMENRTPT': '', 'CMENTPT': '2013-08-06'}, original_path=None), SDTMDatasetMetadata(name='MH', label=' Medical History', filename='mh.csv', file_size=491, record_count=4, modification_date='2026-07-03T13:03:26.889708', full_path='C:\\Users\\els_janssens\\CORE\\Rule_Authoring_CDISC_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data\\mh.csv', first_record={'STUDYID': 'CDISCPILOT01', 'DOMAIN': 'MH', 'USUBJID': 'CDISC001', 'MHSEQ': '1', 'MHTERM': "ALZHEIMER'S DISEASE", 'MHEVDTYP': 'SYMPTOM ONSET', 'MHSTDTC': '2004-05-28', 'MHSTDY': '-3108', 'MHENDTC': '', 'MHENDY': '', 'MHENRTPT': '', 'MHENTPT': '2021-05-01'}, original_path=None)].
[INFO 2026-07-03 13:06:39,606 - console_logger.py:44] - is_suitable_for_validation. rule id=CG0045, dataset=CM, result=True
[INFO 2026-07-03 13:06:39,608 - console_logger.py:44] - Downloading dataset from storage. dataset_name=CM, wrapped function=get_dataset
[INFO 2026-07-03 13:06:39,623 - console_logger.py:44] - Downloaded dataset. dataset=<cdisc_rules_engine.models.dataset.pandas_dataset.PandasDataset object at 0x000001F87FE3B440>
[INFO 2026-07-03 13:06:39,630 - console_logger.py:44] - Using dataset build by: <class 'cdisc_rules_engine.dataset_builders.contents_dataset_builder.ContentsDatasetBuilder'>
[INFO 2026-07-03 13:06:39,630 - console_logger.py:44] - Starting check operator: non_empty
[INFO 2026-07-03 13:06:39,631 - console_logger.py:44] - Starting check operator: empty
[INFO 2026-07-03 13:06:39,632 - console_logger.py:44] - Completed check operator: empty
[INFO 2026-07-03 13:06:39,633 - console_logger.py:44] - Completed check operator: non_empty
[INFO 2026-07-03 13:06:39,633 - console_logger.py:44] - Starting check operator: empty
[INFO 2026-07-03 13:06:39,635 - console_logger.py:44] - Completed check operator: empty
[INFO 2026-07-03 13:06:39,641 - console_logger.py:44] - Validated dataset CM. Result = [{'executionStatus': 'issue reported', 'dataset': 'CM', 'domain': 'CM', 'variables': ['CMENTPT', 'CMENRTPT'], 'message': 'CMENRTPT is not populated when CMENTPT is populated.', 'errors': [{'value': {'CMENTPT': '2013-08-06', 'CMENRTPT': None}, 'dataset': 'CM', 'row': 1, 'USUBJID': 'CDISC005', 'SEQ': 1}, {'value': {'CMENTPT': '2013-08-06', 'CMENRTPT': None}, 'dataset': 'CM', 'row': 2, 'USUBJID': 'CDISC005', 'SEQ': 4}, {'value': {'CMENTPT': '2014-03-08', 'CMENRTPT': None}, 'dataset': 'CM', 'row': 3, 'USUBJID': 'CDISC017', 'SEQ': 1}, {'value': {'CMENTPT': '2014-03-08', 'CMENRTPT': None}, 'dataset': 'CM', 'row': 4, 'USUBJID': 'CDISC017', 'SEQ': 2}, {'value': {'CMENTPT': '2014-03-08', 'CMENRTPT': None}, 'dataset': 'CM', 'row': 5, 'USUBJID': 'CDISC017', 'SEQ': 3}]}]
[INFO 2026-07-03 13:06:39,641 - console_logger.py:44] - Validating MH. rule={'core_id': 'CG0045', 'author': 'CDISC', 'reference': [[{'Citations': [{'Cited_Guidance': 'The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. This is the sponsor-defined reference point referred to by --ENRTPT.', 'Document': 'Model v2.0', 'Item': '--ENTPT', 'Section': 'Timing'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], [{'Citations': [{'Cited_Guidance': 'Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.7', 'Item': 'Table 2.2.5.1: --ENRTPT', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], [{'Citations': [{'Cited_Guidance': '(--ENRTPT) Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.4', 'Item': 'Specification', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}]], 'sensitivity': 'Record', 'executability': 'fully executable', 'description': 'Raise an error when --ENTPT is populated but --ENRTPT is not populated.', 'authorities': [{'Organization': 'CDISC', 'Standards': [{'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': 'The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. This is the sponsor-defined reference point referred to by --ENRTPT.', 'Document': 'Model v2.0', 'Item': '--ENTPT', 'Section': 'Timing'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.4'}, {'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': 'Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.7', 'Item': 'Table 2.2.5.1: --ENRTPT', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.3'}, {'Name': 'SDTMIG', 'References': [{'Citations': [{'Cited_Guidance': '(--ENRTPT) Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.', 'Document': 'Model v1.4', 'Item': 'Specification', 'Section': '2.2.5 Timing Variables for All Classes'}], 'Origin': 'SDTM and SDTMIG Conformance Rules', 'Rule_Identifier': {'Id': 'CG0045', 'Version': '1'}, 'Version': '2.0'}], 'Version': '3.2'}]}], 'standards': [{'Name': 'SDTMIG', 'Version': '3.4', 'Substandard': None}, {'Name': 'SDTMIG', 'Version': '3.3', 'Substandard': None}, {'Name': 'SDTMIG', 'Version': '3.2', 'Substandard': None}], 'classes': {'Include': ['ALL']}, 'domains': {'Include': ['ALL']}, 'entities': None, 'rule_type': 'Record Data', 'conditions': <cdisc_rules_engine.models.rule_conditions.condition_composite.ConditionComposite object at 0x000001F800106CC0>, 'actions': [{'name': 'generate_dataset_error_objects', 'params': {'message': '--ENRTPT is not populated when --ENTPT is populated.'}}], 'use_case': None, 'data_structures': None, 'status': 'Draft', 'output_variables': ['--ENTPT', '--ENRTPT']}. dataset_path=C:\Users\els_janssens\CORE\Rule_Authoring_CDISC_training\cdisc-open-rules-training\Unpublished\NEW-RULE\negative\01\data\mh.csv. datasets=[SDTMDatasetMetadata(name='CM', label='Concomitant/Prior Medications', filename='cm.csv', file_size=751, record_count=5, modification_date='2026-07-03T13:03:20.750712', full_path='C:\\Users\\els_janssens\\CORE\\Rule_Authoring_CDISC_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data\\cm.csv', first_record={'STUDYID': 'CDISCPILOT01', 'DOMAIN': 'CM', 'USUBJID': 'CDISC005', 'CMSEQ': '1', 'CMTRT': 'CENTRUM SILVER', 'CMINDC': 'PROPHYLAXIS OR NON-THERAPEUTIC USE', 'CMDOSE': '1', 'CMDOSU': 'TABLET', 'CMDOSFRQ': '', 'CMROUTE': 'ORAL', 'EPOCH': 'SCREENING', 'CMSTDTC': '2012-03', 'CMENDTC': '', 'CMSTDY': '', 'CMENDY': '', 'CMENRTPT': '', 'CMENTPT': '2013-08-06'}, original_path=None), SDTMDatasetMetadata(name='MH', label=' Medical History', filename='mh.csv', file_size=491, record_count=4, modification_date='2026-07-03T13:03:26.889708', full_path='C:\\Users\\els_janssens\\CORE\\Rule_Authoring_CDISC_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data\\mh.csv', first_record={'STUDYID': 'CDISCPILOT01', 'DOMAIN': 'MH', 'USUBJID': 'CDISC001', 'MHSEQ': '1', 'MHTERM': "ALZHEIMER'S DISEASE", 'MHEVDTYP': 'SYMPTOM ONSET', 'MHSTDTC': '2004-05-28', 'MHSTDY': '-3108', 'MHENDTC': '', 'MHENDY': '', 'MHENRTPT': '', 'MHENTPT': '2021-05-01'}, original_path=None)].
[INFO 2026-07-03 13:06:39,641 - console_logger.py:44] - is_suitable_for_validation. rule id=CG0045, dataset=MH, result=True
[INFO 2026-07-03 13:06:39,642 - console_logger.py:44] - Downloading dataset from storage. dataset_name=MH, wrapped function=get_dataset
[INFO 2026-07-03 13:06:39,652 - console_logger.py:44] - Downloaded dataset. dataset=<cdisc_rules_engine.models.dataset.pandas_dataset.PandasDataset object at 0x000001F80018F230>
[INFO 2026-07-03 13:06:39,658 - console_logger.py:44] - Using dataset build by: <class 'cdisc_rules_engine.dataset_builders.contents_dataset_builder.ContentsDatasetBuilder'>
[INFO 2026-07-03 13:06:39,658 - console_logger.py:44] - Starting check operator: non_empty
[INFO 2026-07-03 13:06:39,659 - console_logger.py:44] - Starting check operator: empty
[INFO 2026-07-03 13:06:39,660 - console_logger.py:44] - Completed check operator: empty
[INFO 2026-07-03 13:06:39,660 - console_logger.py:44] - Completed check operator: non_empty
[INFO 2026-07-03 13:06:39,661 - console_logger.py:44] - Starting check operator: empty
[INFO 2026-07-03 13:06:39,662 - console_logger.py:44] - Completed check operator: empty
[INFO 2026-07-03 13:06:39,669 - console_logger.py:44] - Validated dataset MH. Result = [{'executionStatus': 'issue reported', 'dataset': 'MH', 'domain': 'MH', 'variables': ['MHENTPT', 'MHENRTPT'], 'message': 'MHENRTPT is not populated when MHENTPT is populated.', 'errors': [{'value': {'MHENTPT': '2021-05-01', 'MHENRTPT': None}, 'dataset': 'MH', 'row': 1, 'USUBJID': 'CDISC001', 'SEQ': 1}, {'value': {'MHENTPT': '2021-02-15', 'MHENRTPT': None}, 'dataset': 'MH', 'row': 2, 'USUBJID': 'CDISC002', 'SEQ': 1}, {'value': {'MHENTPT': '2015-05-09', 'MHENRTPT': None}, 'dataset': 'MH', 'row': 3, 'USUBJID': 'CDISC003', 'SEQ': 1}, {'value': {'MHENTPT': '2011-06-11', 'MHENRTPT': None}, 'dataset': 'MH', 'row': 4, 'USUBJID': 'CDISC004', 'SEQ': 1}]}]
[INFO 2026-07-03 13:06:39,755 - console_logger.py:44] - Done Rule execution, creating reports
Output: C:\Users\els_janssens\CORE\Rule_Authoring_CDISC_training\cdisc-open-rules-training\Unpublished\NEW-RULE\negative\01\results\results.json
2 changes: 2 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/.env
Original file line number Diff line number Diff line change
@@ -0,0 +1,2 @@
PRODUCT=SDTMIG
VERSION=3-4
3 changes: 3 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/_datasets.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,3 @@
Filename,Label
cm,Concomitant/Prior Medications
mh, Medical History
30 changes: 30 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/_variables.csv
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@@ -0,0 +1,30 @@
dataset,variable,label,type,length
cm,STUDYID,Study Identifier,Char,12
cm,DOMAIN,Domain Abbreviation,Char,2
cm,USUBJID,Unique Subject Identifier,Char,8
cm,CMSEQ,Sequence Number,Num,8
cm,CMTRT,"Reported Name of Drug, Med, or Therapy",Char,200
cm,CMINDC,Indication,Char,200
cm,CMDOSE,Dose per Administration,Num,8
cm,CMDOSU,Dose Units,Char,6
cm,CMDOSFRQ,Dosing Frequency per Interval,Char,3
cm,CMROUTE,Route of Administration,Char,24
cm,EPOCH,Epoch,Char,9
cm,CMSTDTC,Start Date/Time of Medication,Char,10
cm,CMENDTC,End Date/Time of Medication,Char,10
cm,CMSTDY,Study Day of Start of Medication,Num,8
cm,CMENDY,Study Day of End of Medication,Num,8
cm,CMENRTPT,End Relative to Reference Time Point,Char,7
cm,CMENTPT,End Reference Time Point,Char,10
mh,STUDYID,Study Identifier,Char,12
mh,DOMAIN,Domain Abbreviation,Char,2
mh,USUBJID,Unique Subject Identifier,Char,8
mh,MHSEQ,Sequence Number,Num,8
mh,MHTERM,Reported Term for the Medical History,Char,19
mh,MHEVDTYP,Medical History Event Date Type,Char,13
mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10
mh,MHSTDY,Study Day of Start of Observation,Num,8
mh,MHENDTC,End Date/Time of Medical History Event,Char,50
mh,MHENDY,Study Day of End of Observation,Num,8
mh,MHENRTPT,End Relative to Reference Time Point,Char,50
mh,MHENTPT,End Reference Time Point,Char,50
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