Special Topic: Validation Check Macros

These SAS Clinical Standards Toolkit design requirements shape the implementation of the SAS Clinical Standards Toolkit validation code:

Code modules should be generic and reusable across standards. Fourteen check macros support CDISC SDTM 3.1.1 and 3.1.2 validation. CDISC CRT-DDS 1.0 uses six of these macros.
Code must run with SAS 9.3.
Code should be written as SAS macros.
SAS macros should have simple parameter signatures. All macros accept a single parameter, _cstControl, which is a single-observation data set that contains check-specific metadata.
SAS macros should be implemented as non-compiled open code.
SAS macros should be callable using the SAS autocall facility. The SAS Clinical Standards Toolkit framework supports a single SAS macros library. Each SAS Clinical Standards Toolkit standard supports an additional macros library, and the macro library is available using the SAS autocall path.
Code modules should be generic and reusable with multiple validation checks. The SAS Clinical Standards Toolkit check macros support 150 unique CDISC SDTM 3.1.1 validation checks, 243 unique CDISC SDTM 3.1.2 validation checks, 11 unique CDISC CRT-DDS validation checks, and multiple standards. The SAS Clinical Standards Toolkit check macros support validation of CDISC SDTM, CDISC ADaM, CDISC CRT-DDS, and CDISC ODM files.
To support code generalization, use metadata-driven techniques to provide check-specific information to the check macros, even including which check macro to call.
Code should write processing results to a single validation Results data set. This Results data set should be available for post-process review and reporting.

These design requirements should be used when developing custom validation check macros. This table identifies and describes the purpose of each of the check macros provided with the SAS Clinical Standards Toolkit.

SAS Clinical Standards Toolkit Validation Check Macros

Check Macro	Code Logic Style	Description of Purpose
cstcheck_column	Statement	Identifies any invalid column values or attributes.
cstcheck_columncompare	Step	Supports comparison of column values.
cstcheck_columnexists	By default, this check does not require the use of codeLogic. If the check metadata includes a non-null value of codeLogic, then DATA step code logic is required.	Determines whether one or more of the columns defined in columnScope exist in each of the tables defined in tableScope.
cstcheck_columnvarlist	Step	Supports comparison of multiple columns within the same data set or across multiple data sets.
cstcheck_comparedomains	Step	Compares values for one or more columns in one domain with values for those same columns in another domain.
cstcheck_crossstdcomparedomains	Step	Generally compares values for 1+ columns in one table against either those same columns in another domain in another standard, or compares values against metadata from the comparison standard.
cstcheck_crossstdmetamismatch	Step	Identifies inconsistencies between metadata across registered standards.
cstcheck_dsmismatch	Step	Identifies any data set mismatches between study and template metadata and the source data library.
cstcheck_metamismatch	Step	Identifies inconsistencies between study and reference column metadata.
cstcheck_notconsistent	Step	Identifies any inconsistent column values across records.
cstcheck_notimplemented	(not used)	Placeholder to report that a check is not yet implemented.
cstcheck_notincodelist	If lookuptype=DATASET, DATA step code logic required Else, DATA step code logic is optional	Identifies any column values inconsistent with controlled terminologies. Requires reference to the SAS format search path built based on type=FMTSEARCH records in the SASReferences control file. Example is a **STAT value is found other than 'NOT DONE.'
cstcheck_notsorted	(not used)	Identifies any domain that is not sorted by the keys defined in the metadata.
cstcheck_notunique	Not used for functions 1 through 3; DATA step for function 4	A multi-function macro that assesses the uniqueness of data sets, columns, or value-pairs from two columns. Function 1: Is data set unique by a set of columns? Function 2: For any subject, are column values unique? Function 3: Does a combination of two columns have unique values? Function 4: Are the values in one column (Column2) consistent in each value of another column (Column1)?
cstcheck_recmismatch	Step	Identifies any record mismatches across domains (domain as referenced in another domain).
cstcheck_recnotfound	Step	Compares the consistency of one or more columns across two tables or enables the comparison of the consistency of one <table>.<column> with another <table>.<column>.
cstcheck_violatesstd	Statement	Identifies any invalid column values defined in a reference standard.
cstcheck_zeroobs	(not used)	Identifies any data set with zero observations.

Each validation check macro follows a standard basic workflow. Several of the validation check macros perform more complex operations and multiple functions. The basic workflow includes these events:

Call the utility macro %cstutil_readcontrol, which translates the validation check metadata passed as the input parameter into local macro variables for check macro processing.
Evaluate required check macro-specific metadata values.
Call the utility macro %cstutil_buildcollist (or, if processing only domains, %cstutil_builddomlist), which evaluates the requested scope of the specific validation check (that is, which tables and columns are to be included when running the check).
Loop through the target tables and columns identified in step 3.
Perform the logic required to properly assess the validation check. This might be the check macro code itself, or the code in the validation check metadata codeLogic field.
Write any informational or error messages to the Results data set. Metrics are written to the Metrics data set.
Clean up any Work files local to the check macro processing.

This table provides the distribution of validation checks by check macro for both CDISC SDTM 3.1.1 and 3.1.2. For the distribution of validation checks by check macro for CDISC CRT-DDS 1.0, see CDISC CRT-DDS 1.0 Validation Checks.

CDISC SDTM Validation Checks

Check Macro (codesource)	Type of Check (checktype)	Unique Check Identifier (checkid) (add SDTM prefix)
cstcheck_column	Column	0271, 0493, 0494, 0860
	ColumnAttribute	0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131
	ColumnValue	0204, 0205, 0206, 0207, 0217, 0220, 0222, 0251, 0352, 0354, 0355, 0490, 0506, 0521, 0562
	Date	0101, 0102
cstcheck_columncompare	Column	0208, 0212, 0213, 0214, 0215, 0216, 0219, 0223, 0225, 0226, 0231, 0232, 0233, 0351, 0353, 0405, 0406, 0408, 0409, 0410, 0411, 0412, 0413, 0414, 0415, 0416, 0417, 0418, 0419, 0422, 0423, 0462, 0463, 0500, 0501, 0502, 0503, 0507, 0511, 0534, 0541, 0551, 0561, 0843
cstcheck_columncompare	Date	0209, 0210, 0211, 0407
cstcheck_columnvarlist	ColumnValue	0452
cstcheck_comparedomains	Multitable	0645, 0801, 0804, 0812, 0842, 0844, 0845, 0846
cstcheck_dsmismatch	Metadata	0004, 0005, 0006, 0017
cstcheck_metamismatch	Metadata	0011, 0012, 0013, 0014, 0015, 0019, 0020, 0022, 0023, 0030, 0031, 0032, 0033
cstcheck_notconsistent	Multirecord	0604, 0605, 0607, 0621, 0643, 0644
cstcheck_notconsistent	Multitable	0807
cstcheck_notimplemented	Cntlterm	0449, 0474
	Date	0190, 0191, 0192, 0193
	Derivation	0441, 0442, 0443
	Metadata	0016, 0034, 0035, 0036, 0037, 0038, 0039
	Multirecord	0672, 0673
cstcheck_notincodelist	Cntlterm	0218, 0221, 0302, 0401, 0402, 0403, 0450, 0451, 0453, 0454, 0455, 0456, 0457, 0458, 0459, 0460, 0461, 0464, 0465, 0466, 0467, 0470, 0471, 0472, 0473, 0475, 0476, 0477, 0478, 0479, 0480, 0481, 0482, 0483, 0484, 0485, 0486, 0487, 0488, 0489, 0491, 0492, 0495, 0496, 0497, 0498, 0499, 0504, 0505, 0508, 0509, 0510, 0512, 0513, 0514, 0515, 0516, 0517, 0518, 0522, 0523, 0531, 0532, 0533, 0570, 0571, 0572, 0573, 0574, 0575, 0576, 0580
cstcheck_notincodelist	Column	0301, 0303
cstcheck_notsorted	Multirecord	0601
cstcheck_notunique	Multirecord	0602, 0603, 0622, 0623, 0631, 0641, 0642, 0651, 0661, 0662, 0671, 0808, 0809
cstcheck_recmismatch	Multitable	0851, 0861, 0862, 0863, 0864, 0865, 0866, 0871, 0872
cstcheck_recnotfound	Multitable	0802, 0803, 0805, 0806, 0811, 0821, 0822, 0823, 0831, 0836, 0841
cstcheck_violatesstd	Column	0201, 0202, 0203, 0606
cstcheck_zeroobs	Metadata	0001, 0002, 0003

CDISC CRT-DDS 1.0 Validation Checks

Check Macro (codesource)	Check Type (checktype)	Unique Check Identifier (checkid) )	Corresponding CRT-DDS Validation Number*
cstcheck_column	ColumnValue	CRT0106	0013, 0105, 0119, 0140, 0145
		CRT0107	0068
		CRT0108	0077, 0100, 0101
		CRT0109	0131
cstcheck_violatesstd	Column	CRT0101	0000, 0001, 0008, 0009, 0010, 0011, 0012, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0035, 0036, 0037, 0038, 0040, 0043, 0044, 0046, 0048, 0049, 0051, 0052, 0055, 0056, 0058, 0059, 0060, 0062, 0063, 0066, 0067, 0070, 0071, 0073, 0075, 0078, 0079, 0080, 0081, 0083, 0086, 0089, 0090, 0091, 0092, 0094, 0095, 0096, 0097, 0099, 0104, 0106, 0107, 0108, 0109, 0110, 0112, 0114, 0116, 0117, 0118, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0130, 0132, 0133, 0135, 0137, 0141, 0142, 0143, 0144, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154
cstcheck_notunique	Multirecord	CRT0100	0000, 0002, 0004, 0009, 0010, 0015, 0022, 0027, 0029, 0043, 0055, 0066, 0071, 0092, 0096, 0110, 0127, 0135, 0142, 0144
cstcheck_recnotfound	Multitable	CRT0110	0008, 0012, 0014, 0017, 0018, 0019, 0020, 0021, 0025, 0026, 0028, 0030, 0031, 0033, 0034, 0035, 0037, 0038, 0048, 0049, 0052, 0059, 0060, 0063, 0069, 0070, 0080, 0081, 0084, 0085, 0086, 0091, 0094, 0095, 0102, 0103, 0104, 0106, 0107, 0108, 0109, 0116, 0117, 0118, 0120, 0121, 0124, 0125, 0126, 0132, 0133, 0137, 0141, 0143, 0146
		CRT0111	0023, 0072, 0111
		CRT0112	0003, 0024, 0093, 0134, 0138
cstcheck_recmismatch	Multitable	CRT0113	0041, 0042, 0053, 0054, 0064, 0065, 0087, 0088, 0139
cstcheck_notincodelist	Controlterm	CRT0114	0005, 0006, 0007, 0032, 0039, 0045, 0047, 0050, 0057, 0061, 0074, 0076, 0082, 0098, 0113, 0115, 0129

For a full listing of validation checks, see Validation Checks.

More complete documentation is provided for each check macro in Macro Application Programming Interface. This information is derived from the code header. See Special Topic: Validation Customization.