Verify SAS datasets against CDISC standards

%cdisc (datlib = data library, 
        datname = dataset name);

Details
This tool verifies SAS datasets against CDISC submission data domain models version 3.1.1 as specified at: SDTM--3.1.1ImplementationGuide.pdf.  It is intended to catch deviations of standards including the following:

1. Required Fields: Required identifier variables including: DOMAIN, USUBJID, STUDYID and --SEQ.
2. Subject Variable: (4.1.2.3) For variable names, labels and comments, use the word "Subject" when referring to "patients" or "healthy volunteer".
3. Variable Length: (4.1.2.1) Variable names are limited to 8 characters with labels up to 40 characters.
4. Yes/No: (4.1.3.7) Variables where the response is Yes or No (Y/N) should normally be populated for both Yes and No responses.
5. Date Time Format: (4.1.4.1) Date or Datetime must be in ISO 8601 format.
6. Study Day Variable: (4.1.4.4) Study day variable has the name ---DY.
7. Variable Names: (3.2.3) If any variable names used matches CDISC variables, the associated label has to match.
8. Variable Label: (3.2.3) If any variable labels match that of CDISC labels, the associated variable has to match.
9. Variable Type: (3.2.3) If any variables match that of CDISC variables, the associated type has to match.
10. Dataset Names: (3.2.3) If any of the dataset names match CDISC, the associated data label has to match.
11. Dataset Labels: (3.2.3) If any of the dataset label match CDISC, the associated dataset name  has to match.
12. Abbreviations: (10.3.1) (10.4) The following abbreviations are suggested for variable names and data sets.
     

    Acronym	Descriptive Text
    AE	Adverse Events
    AU	Autopsy
    BM	Bone Mineral Density (BMD) Data
    BR	Biopsy
    CM	Concomitant Meds
    CO	Comments
    DA	Drug Accountability
    DC	Disease Characteristics
    DM	Demographics
    DS	Disposition
    DV	Protocol Deviations
    EE	EEG
    EG	EEG
    EX	Exposure
    HU	Healthcare Resource Utilization
    IE	Inclusion/Exclusion
    IM	Imaging
    LB	Laboratory Data
    MB	Microbiology Specimens
    MH	Medical History
    ML	Meal Data
    MS	Microbiology Susceptibility
    OM	Organ Measurements
    PC	PK Concentration
    PE	Physical Exam
    PP	PK Parameters
    PG	Pharmacogenomics
    QS	Questionnaires
    SC	Subject Characteristics
    SE	Subject Elements
    SG	Surgery
    SK	Skin Test
    SL	Sleep (Polysomnography) Data
    SL	Signs and Symptoms
    ST	Stress (Exercise) Test Data
    SU	Substance Use
    SV	Subject Visits
    TA	Trial Arms
    TE	Trial Elements
    TI	Trial Inclusion/Exclusion Criteria
    TS	Trial Summary
    TV	Trial Visits
    VS	Vital Signs

    CAN	ACTION
    ADJ	ADJUSTMENT
    ADJ	ANALYSIS DATASET
    BL	BASELINE
    BRTH	BIRTH
    BOD	BODY
    CAN	CANCER
    CAT	CATEGORY
    C	CHARACTER
    CND	CONDITION
    CLAS	CLASS
    CD	CODE
    COM	COMMENT
    CON	CONCOMITANT
    CONG	CONGENTTAL
    DTC	DATE TIME - CHARACTER
    DY	DAY
    DTH	DEATH
    DECOD	DECODE
    DRV	DERIVED
    DESC	DESCRIPTION
    DISAB	DISABILITY
    DOS	DOSE
    DOS	DOSAGE
    DOSE	DOSE
    DOSE	DOSAGE
    DUR	DURATION
    EL	ELAPSED
    ET	ELEMENT
    EM	EMERGENT
    END	END
    EN	END
    ETHNIC	ETHNICITY
    X	EXTERNAL
    EVAL	EVALUATOR
    EVL	EVALUATION
    FAST	FASTING
    FN	FILENAME
    FL	FLAG
    FRM	FORMULATION, FORM
    FREQ	FREQUENCY
    GR	GRADE
    GRP	GROUP
    HI	HIGHER LIMIT
    HOSP	HOSPITALIZATION
    ID	IDENTIFIER
    INDC	INDICATION
    INDC	INDICATOR
    INT	INTERVAL
    INTP	INTERPRETATION
    INV	INVESTIGATOR
    LIFE	LIFE-THREATENING
    LOC	LOCATION
    LOINC	LOINC CODE
    LO	LOWER LIMIT
    MIE	MEDICALLY-IMPORTANT EVENT
    NAM	NAME
    NST	NON-STUDY THERAPY
    NR	NORMAL RANGE
    ND	NOT DONE
    NUM	NUMBER
    N	NUMERIC
    ONGO	ONGOING
    ORD	ORDER
    ORIG	ORIGIN
    OR	ORIGINAL
    OTH	OTHER
    O	OTHER
    OUT	OUTCOME
    OD	OVERDOSE
    PARM	PARAMETER
    PATT	PATTERN
    POP	POPULATION
    POS	POSITION
    QUAL	QUALIFIER
    REAS	REASON
    REF	REFERENCE
    RF	REFERENCE
    RGM	REGIMEN
    REL	RELATED
    R	RELATED
    REL	RELATIONSHIP
    R	RELATIONSHIP
    RES	RESULT
    RL	RULE
    SEQ	SEQUENCE
    S	SERIOUS
    SER	SERIOUS
    SEV	SEVERITY
    SPEC	SPECIMEN
    SPC	SPECIMEN
    SPEC	SPONSOR
    SPC	SPONSOR
    ST	STANDARD
    STD	STANDARD
    ST	START
    STD	START
    STAT	STATUS
    SCAT	SUBCATEGORY
    SUBJ	SUBJECT
    SUPP	SUPPLEMENTAL
    SYS	SYSTEM
    TXT	TEXT
    TM	TIME
    TPT	TIMEPOINT
    TOT	TOTAL
    TOX	TOXICITY
    TRANS	TRANSITION
    TRT	TREATMENT
    U	UNIT
    U	UNIQUE
    UP	UNPLANNED
    VAR	VARIABLE
    VAL	VALUE
    V	VEHICLE

     
13. SEQ Values: When the --SEQ variable is used, it must have unique values for each USUBJID within each domain.
14. Label Casing: For Dataset labels and variable labels, all non trivial words (more than three characters) must start with a capital letter with the rest of the characters lowercase.
15. Required Values: (4.1.1.5) For required fields such as the ones specified in number 1, check to see if there are values.  If there are any missing, values, report the observation number where it is missing.
16. Similar Parenthesis:  For labels with matching values inside parenthesis such as (Yes/No) within the same dataset, it will check to see if the variables have the same type and length.  If not, it will report the differences.
17. Required Variables: (4.1.1.5) A Required variable is any variable that is basic to the identification of a data record (i.e., essential key variables and a topic variable) or is necessary to make the record meaningful. Required variables should always be included in the dataset and cannot be null for any record.
18. Expected Variable: (4.1.1.5) An Expected variable is any variable necessary to make a record useful in the context of a specific domain. Columns for Expected variables are assumed to be present in each submitted dataset even if some values are null.
19. Zero Rows: (IR4000) Identifies domain table that has zero rows and therefore contains no data.
20. Empty Value: (IR4001)  Identifies a null (empty) value found in a column where (Standard) Core attribute is 'Req' which means required.
21. No Record Baseline: (IR4005) For Findings domains, this identifies subjects where there are no records with a value of 'Y' in the baseline flag variable (Baseline Flag).
22. Consistent Lab Values: (IR4006) For LAB domains, this identifies Short Name of Measurement, Test or Examination values where standard units value (Standard Units) is not consistent across all records.
23. MedDRA Term Mismatch: (IR4007) For AE domains, this identifies records where the value for the Preferred Term could not be found in the MedDRA dictionary.
24. Serious AE: (IR4008) For AE domains, this identifies records where Serious Event='Y' but none of Involves Cancer, Congenital Anomaly or Birth Defect, Persist or Signif Disability/Incapacity, Results in Death, Requires or Prolongs Hospitalization, Is Life Threatening, Other Medically Important Serious Event, or Occurred with Overdose equals 'Y'.
25. Unit and Status Null: (IR4009) Identifies records where Result or Finding in Original Units and Status both have a value, or where both are null.
26. Visit Number Decimal : (IR4010) Identifies records where the value for Visit Number is formatted to more than two decimal places.
27. DM Arm Code: (IR4011) For DM domain, this identifies records that violate the condition [If Arm Code='SCRNFAIL' then Description of Arm must equal 'Screen Failure', and vice versa].
28. TA Arm Code: (IR4012) For TA domain, this identifies records that violate the condition [If Arm Code='SCRNFAIL' then Description of Arm must equal 'Screen Failure', and vice versa].
29. Study Day End: (IR4100) For all timing variables, this identifies records that violate the condition [(Study Day of Start of Observation less than or equal to Study Day of End of Observation)], limited to records where [Study Day of Start of Observation is not null and Study Day of End of Observation is not null].
30. Start End Records: (IR4101) For all timing variables, this identifies records that violate the condition [(Start Date/Time of Observation less than or equal to End Date/Time of Observation)], limited to records where [Start Date/Time of Observation is not null and End Date/Time of Observation is not null].
31. Baseline Null - (IR4102) For all Findings domains, this identifies records that violate the condition [Baseline Flag either 'Y' or null].
32. Derived Flag Null (IR4103)  For findings domains, this identifies records that violate the condition [Derived Flag either 'Y' or null].
33. Reference Periods (IR4104) For Events and Interventions domains, this identifies records that violate the condition [End Relative to Reference Period in('BEFORE','DURING','AFTER','DURING/AFTER','U')], limited to records where [End Relative to Reference Period is not null].
34. Fasting Status Null  (IR4105) For findings domains, this identifies records that violate the condition [Fasting Status in ('Y','N','U')], limited to records where [Fasting Status is not null].
35. Occurrence Null - (IR4106) For Events and Interventions domains, this identifies records that violate the condition [Occurrence in ('Y','N')], limited to records where [Occurrence is not null].
36. Status Not Done (IR4107) Identifies records that violate the condition [Status='NOT DONE'], limited to records where [Status is not null].
37. Reference Period (IR4108) For Events and Interventions domains, this identifies records that violate the condition [Start Relative to Reference Period in ('BEFORE','DURING','AFTER')], limited to records where [Start Relative to Reference Period is not null].
38. Dose Null (IR4109) For Interventions domains, this identifies records that violate the condition [Dose greater than or equal to 0], limited to records where [Dose is not null].
39. Duration Zero (IR4110) For All (Timing) variables, this identifies records that violate the condition [Duration greater than or equal to 0], limited to records where [Duration is not null].
40. Original Units Null (IR4111) For Findings domains, this identifies records that violate the condition [Result or Finding in Original Units is null], limited to records where [Derived Flag='Y'].
41. Format Null (IR4112) For Findings domains, this identifies records that violate the condition [Result or Finding in Standard Format is not null], limited to records where [Derived Flag='Y'].
42. Test Name Length (IR4113) For Findings domains, this identifies records that violate the condition [LENGTH (Name of Measurement, Test or Examination) less than or equal to 40 characters].
43. Short Name Length (IR4114) For Findings domains, this identifies records that violate the condition [LENGTH(Short Name of Measurement, Test or Examination) less than or equal to 8 chars, cannot start with a number or contain special chars].
44. Trial Summary Length (IR4115) For TS domains, this identifies records that violate the condition [LENGTH(Trial Summary Parameter) less than or equal to 40 chars].
45. Trial Summary Short (IR4116) For TS domains, this identifies records that violate the condition [LENGTH(Trial Summary Parameter Short Name) less than or equal to 8 chars, cannot start with a number or contain special chars].
46. End Reference Period (IR4117) For All (Timing) variables, this identifies records that violate the condition [End Relative to Reference Period is not null], limited to records where [End Date/Time of Observation is null].
47. Start Period Null (IR4118) For All (Timing) variables, this identifies records that violate the condition [Start Relative to Reference Period is not null], limited to records where [Start Date/Time of Observation is null].
48. Elapse Time Zero (IR4119) For EX domains, this identifies records that violate the condition [Planned Elapsed Time from Reference Pt greater than or equal to 0], limited to records where [Planned Elapsed Time from Reference Pt is not null].
49. Evaluation Interval Zero (IR4120) For All (Timing) variables, this identifies records that violate the condition [Evaluation Interval greater than or equal to 0], limited to records where [Evaluation Interval is not null].
50. Toxicity Grade Valid (IR4121) For Events domains, this identifies records that violate the condition [Toxicity Grade is a valid number], limited to records where [Toxicity Grade is not null].
51. Reason Done Null (IR4122) For All domains, this identifies records that violate the condition [Reason Not Done is null], limited to records where [Status is null].
52. Date Collection Null (IR4123) For Findings domains, this identifies records that violate the condition [Date/Time of Collection is not null], limited to records where [End Date/Time of Observation is not null].
53. Date Less End Date (IR4124) For Findings domains, this identifies records that violate the condition [Date/Time of Collection less than or equal to End Date/Time of Observation], limited to records where [Date/Time of Collection is not null and End Date/Time of Observation exists].
54. Results Units Null (IR4125) For Findings domains, this identifies records that violate the condition [Result or Finding in Original UnitsU is not null], limited to records where [Result or Finding in Original Units is not null].
55. Original Units Null (IR4126) For Findings domains, this identifies records that violate the condition [Result or Finding in Original UnitsU is null], limited to records where [Result or Finding in Original Units is null].
56. Upper Limit Range (IR4127) For Findings domains, this identifies records that violate the condition [Normal Range Upper Limit-Standard Units greater than or equal to Normal Range Lower Limit-Standard Units], limited to records where [Normal Range Upper Limit-Standard Units is not null and STNRHI is not null].
57. Standard Unit Null (IR4128) For Findings domains, this identifies records that violate the condition [Standard Units is not null], limited to records where [Result or Finding in Standard Format is not null].
58. Standard Format Null (IR4129) For Findings domains, this identifies records that violate the condition [Standard Units is null], limited to records where [Result or Finding in Standard Format is null].
59. Start Observation Null (IR4130) For All (Timing) variables, this identifies records that violate the condition [Start Date/Time of Observation is not null], limited to records where [End Date/Time of Observation is not null].
60. Time Name Null (IR4131) For All (Timing) variables, this identifies records that violate the condition [Planned Time Point Name is not null], limited to records where [Planned Time Point Number is not null].
61. Time Number Null (IR4132) For All (Timing) variables, this identifies records that violate the condition [Planned Time Point Number is not null], limited to records where [Planned Time Point Name is not null].
62. Time Reference Null (IR4133) For All (Timing) variables, this identifies records that violate the condition [Time Point Reference is not null], limited to records where [Elapsed Time from Reference Point is not null].
63. Dose Unit Null (IR4134) For Interventions domains, this identifies records that violate the condition [Dose Units is not null], limited to records where [Dose is not null].
64. Result Format Null (IR4135) For Findings domains, this identifies records that violate the condition [Result or Finding in Standard Format is not null], limited to records where [Result or Finding in Original Units is not null].
65. Code List Found (IR4136) For All domains, this identifies records where values are not found in the study-specific codelist attached to a variable.
66. Study Day Zero (IR4137) For All domains, this identifies records that violate the condition [Study Day of Visit/Collection/Exam doesn't equal 0].
67. Treatment Emergent AE - (IR4255) For AE domains, this identifies a Sponsor-provided Flag Variable for 'Treatment emergent AE' where the derivation can't be executed.
68. Clinically Significant Lab (IR4256) For LB domains, this identifies a Sponsor-provided Flag Variable for 'Clinically Significant Lab' where the derivation can't be executed.
69. Clinically Significant Vitals(IR4257) For VS domains, this identifies a Sponsor-provided Flag Variable for 'Clinically Significant Vital Sign' where the derivation can't be executed.
70. SUPPQUAL USBJID (IR4258) For Supplemental Qualifiers domains, this identifies a domain that appears to contain supplemental qualifier data but does not contain the Unique Subject Identifier variable.
71. SAS Label - (IR4260) For All domains, this identifies a variable present in SAS dataset but not present in (study specific) description file.
72. DM Sequence (IR4500) For All domains, this identifies non-Sequence Number domain subjects not found in the Demographics domain.
73. Subject Visit (IR4501) For All domains, this identifies Unique Subject Identifier+Visit Name+Visit Number combinations not found in the SV domain.
74. Arm Code TA (IR4502) For DM domains, this identifies records where the value for Arm Code is not found in the TA domain.
75. Subject Element Code (IR4503) For All domains, this identifies records where the value for Subject Element Code is not found in the TE domain.
76. IE Short Name (IR4504) For IE domains, this identifies records where the value for Inclusion/Exclusion Criterion Short Name is not found in the TI domain.
77. DS Subject (IR4505) For DM domains, this identifies Sequence Number subjects where no record for the subject is found in the Disposition domain.
78. DM Sequence(IR4506) For DM domains, this identifies Sequence Number subjects where no record for the subject is found in the Exposure domain.
79. Arm Code DM (IR4507) For DM domains, this identifies Sequence Number treatment arms (Description of Arm+Arm Code combination) not found in the TA domain.
80. Unknown CO (IR4508) For CO domains, this identifies CO domain reference to an unknown related domain.
81. Related Records Unknown (IR4509) For RELREC domains, this identifies Related Records domain reference to an unknown related domain.
82. Unknown SUPQUAL (IR4510) For Supplemental Qualifiers domains, this identifies Supplemental Qualifiers domain reference to an unknown related domain.
83. RELREC Key (IR4511) For RELREC domains, this identifies Related Records domain reference to a key variable that isn't defined in the target domain.
84. SUPPQUAL Key (IR4512) For Supplemental Qualifiers domains, this identifies Supplemental Qualifiers domain reference to a key variable that isn't defined in the target domain.
85. RELREC Target Domain (IR4513) For RELREC domains, this identifies Related Records domain reference to a record that doesn't exist in the target domain.
86. SUPPQUAL Target Domain (IR4514) For Supplemental Qualifiers domains, this identifies Supplemental Qualifiers domain reference to a record that doesn't exist in the target domain.
87. DM Unique Subject (R4005) For DM domains, this identifies records where values for Unique Subject ID variable(s) are not unique, limited to records where [Unique Subject ID is not null].
88. Age Greater Zero (R4006) For DM domains, this identifies records that violate the condition [AGE greater than or equal to 0], limited to records where [AGE is not null].
89. Sex Code List (R4007) For DM domains, this identifies records where value for [SEX] is not found in Codelist [SEX].
90. Country Codelist (R4008) For DM domains, this identifies records where value for [COUNTRY] is not found in Codelist [COUNTRY].
91. Yes No Codelist(R4019) For AE domains, this identifies records where value for [Serious Event] is not found in Codelist [YESNO].
92. Birth Defect Codelist (R4023) For AE domains, this identifies records where value for [Congenital Anomaly or Birth Defect] is not found in Codelist [YESNO], limited to records where [Congenital Anomaly or Birth Defect is not null].
93. Disability Codelist (R4024) For AE domains, this identifies records where value for [Persist or Signif Disability/Incapacity] is not found in Codelist [YESNO], limited to records where [Persist or Signif Disability/Incapacity is not null].
94. Death Codelist (R4025) For AE domains, this identifies records where value for [Results in Death] is not found in Codelist [YESNO], limited to records where [Results in Death is not null].
95. Hospitalization Codelist (R4026) For AE domains, this identifies records where value for [Requires or Prolongs For Hospitalization] is not found in Codelist [YESNO], limited to records where [Requires or Prolongs Hospitalization is not null].
96. Life Threatening Codelist (R4027) For AE domains, this identifies records where value for [Is Life Threatening] is not found in Codelist [YESNO], limited to records where [Is Life Threatening is not null].
97. Inclusion Exclusion Codelist (R4031) For IE domains, this identifies records where value for [Inclusion/Exclusion Category] is not found in Codelist [INCEX], limited to records where [Inclusion/Exclusion Category is not null].
98. Conmed Codelist (R4043) For AE domains, this identifies records where value for [Concomitant or Additional Trtmnt Given] is not found in Codelist [YESNO].
99. Cancer Codelist (R4045) For AE domains, this identifies records where value for [Involves Cancer] is not found in Codelist [YESNO], limited to records where [Involves Cancer is not null].
    (R4046) For AE domains, this identifies records where value for [Other Medically Important Serious Event] is not found in Codelist [YESNO], limited to records where [Other Medically Important Serious Event is not null].
100. Overdose Codelist (R4047) For AE domains, this identifies records where value for [Occurred with Overdose] is not found in Codelist [YESNO], limited to records where [Occurred with Overdose is not null].
101. Age Unit Codelist (R4062) For DM domains, this identifies records where value for [AGEU] is not found in Codelist [AGEUNITS2], limited to records where [AGEU is not null].
102. IE Units Codelist (R4071) For IE domains, this identifies records where value for [I/E Criterion Original Result] is not found in Codelist [YESNO], limited to records where [I/E Criterion Original Result is not null].
103. Study Format Codelist (R4072) For IE domains, this identifies records where value for [I/E Criterion Result in Std Format] is not found in Codelist [YESNO], limited to records where [I/E Criterion Result in Std Format is not null].
104. IE Results Codelist (R4073) For IE domains, this identifies records that violate the condition [I/E Criterion Original Result = I/E Criterion Result in Std Format].
105. SUPPQUAL Study ID (R4083) For Supplemental Qualifiers domains, this identifies records where values for [Study Identifier, Unique Subject Identifier, Identifying Variable, Identifying Variable Value, Qualifier Variable Name] variable(s) are not unique.
106. DM Reference Date (R4096) For DM domains, this identifies records that violate the condition [Subject Reference Start Date/Time is not null], limited to records where [Arm Code doesn't equal 'SCRNFAIL'].
107. DM End Date (R4097) For DM domains, this identifies records that violate the condition [Subject Reference End Date/Time is not null], limited to records where [Arm Code doesn't equal 'SCRNFAIL'].
108. TE End Element (R4101) For TE domains, this identifies records that violate the condition [Rule for End of Element is not null or Planned Duration of Element is not null].
109. AE Death (R4102) For AE domains, this identifies records that violate the condition [Results in Death='Y'], limited to records where [Outcome of Adverse Event='FATAL'].
110. AE Fatal (R4103) For AE domains, this identifies records that violate the condition [Outcome of Adverse Event='FATAL'], limited to records where [Results in Death='Y'].
111. DV Count (R4104) For DV domains, this identifies records that violate the condition [count (distinct Protocol Deviation Term) = count(distinct Protocol Deviation Coded Term)], limited to records where [Protocol Deviation Term is not null].
112. SE Unplanned Element (R4105) For SE domains, this identifies records that violate the condition [Description of Unplanned Element is not null], limited to records where [Subject Element Code='UNPLAN'].
113. Age Unit Null (R4106) For DM domains, this identifies records that violate the condition [AGEU is not null], limited to records where [AGE is not null].
     

The findings from the above evaluation will be stored in a dataset named WORK.CDISC.   Each test case will be identified by a column named "case" which corresponds to each item listed above.  An HTML report will be generated documenting the findings.  The report name will be the same name as the current program with the (.html) file extension.

If the macro is called without any parameters, a dialog box will be opened to allow users to select the datasets to be evaluated.

Example

%cdisc (datlib=mylib, 
        datname=ae);

%cdisc (datlib=mylib, 
        datname=ae*);

%cdisc (datlib=mylib, 
        datname=ae demog term);