• The following instructions are accomplished through Windows Explorer.
• Perform each test by performing the steps specified by the instructions.  
• Evaluate the results of each step by comparing them with results described in the Documentation column. 
• All the script SAS files can be downloaded as one compressed file at: cdisc_scripts.zip

Note: Download the dataset  _3_1_1.sas7bdat and config.sas7bdat for the SDTMIG 3.1.1 model. Paste these datasets to a folder 'data' where the datasets are submitted.

Instructions 1
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc1.sas program and select "Batch Submit".

3. Review the cdisc1.log file and verify that the following messages are produced.

   • ERROR: [cdisc] has an invalid library specified by DATLIB.  

   • ERROR: [cdisc] was unable to find data specified by DATNAME. 

4. This can be verified against the cdisc1.log found in the benchmark area.

Instructions 2
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc2.sas program and select "Batch Submit".

3. Review the cdisc2.log file and verify that there are no error messages.

4. Review the cdisc2.html file and verify that there are 2 data table name cdisc2_b and cdisc2_c displayed on this report.

5. Compare the log and html file generated including: cdisc2.log and cdisc2.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 2b
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc2b.sas program and select "Batch Submit".

3. Review the cdisc2b.log file and verify that there are no error messages.

4. Review the cdisc2b.html file and verify that there are 3 data table name cdisc2b_1, cdisc2b_2 and cdisc2b_3.

5. Verify that you can navigate to the variable of each dataset through Variable Navigator pull down list.

6. Compare the log and html file generated including: cdisc2b.log and cdisc2b.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 3
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc3.sas program and select "Batch Submit".

3. Review the cdisc3.log file to ensure that there are no error messages.  

4. Review the cdisc3.html to verify the comments following capture case number 1:

   • The report had three comments:

     • Data Missing Variable USUBJID

     • Data Missing Variable STUDYID

5. Compare the log and html file generated including: cdisc3.log and cdisc3.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 4
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc4.sas program and select "Batch Submit".

3. Review the cdisc4.log file to ensure that there are no error messages.

4. Review the cdisc4.html to verify the comments following capture case number 2:

   • For variable Patient "Variable Name need to be (Subject)"

   • For variables var1 and var2 "Variable Label needs to include (Subject)"

   • For variable var3 "Variable Values contain (patient) rather than (Subject)"

   • For variable var4 "Variable value contains (healthy volunteer) rather than (Subject)"

5. Compare the log and html file generated including: cdisc4.log and cdisc4.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 5
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc5.sas program and select "Batch Submit".

3. Review the cdisc5.log file to ensure that there are no error messages.

4. Review the cdisc5.html to verify the comments following capture case number 3:

   • Variable var1 has comments "Variable Label > 40 Characters"

   • Variable GREATERTHAN8 has comments "Variable Name > 8 Characters"

5. Compare the log and html file generated including: cdisc5.log and cdisc5.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 6
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc6.sas program and select "Batch Submit".

3. Review the cdisc6.log file to ensure that there are no error messages.

4. Review the cdisc6.html to verify the comment following capture case number 4:

   • Variable var1 has comments "Variable values of variable must contain both YES, NO and not missing"

5. Compare the log and html file generated including: cdisc6.log and cdisc6.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 7
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc7.sas program and select "Batch Submit".

3. Review the cdisc7.log file to ensure that there are no error messages.

4. Review the cdisc7.html to verify the comment following capture case number 5:

   • Variable var3 has comments "Date or Datetime must be in ISO 8601 format."

5. Compare the log and html file generated including: cdisc7.log and cdisc7.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 8
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc8.sas program and select "Batch Submit".

3. Review the cdisc8.log file to ensure that there are no error messages.

4. Review the cdisc8.html to verify the comment following capture case number 6:

   • Variable var1 has comments "Variable name needs to be ---DY"

5. Compare the log and html file generated including: cdisc8.log and cdisc8.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 9
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc9.sas program and select "Batch Submit".

3. Review the cdisc9.log file to ensure that there are no error messages.

4. Review the cdisc9.html to verify the comment following capture case number 7:

   • Variable SEX has comments "Variable name matches guidelines but not label which is: Sex"

5. Compare the log and html file generated including: cdisc9.log and cdisc9.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 10
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc10.sas program and select "Batch Submit".

3. Review the cdisc10.log file to ensure that there are no error messages.

4. Review the cdisc10.html to verify the comment following capture case number 8:

   • Variable NOTRACE has comments "Label has multiple matches in guidelines. Matched variables with same label include: RACE"

5. Compare the log and html file generated including: cdisc10.log and cdisc10.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 11
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc11.sas program and select "Batch Submit".

3. Review the cdisc11.log file to ensure that there are no error messages.

4. Review the cdisc11.html to verify the comment following capture case number 9:

   • Variable RACE has comments "Variable name matches guidelines but not variable type"

5. Compare the log and html file generated including: cdisc11.log and cdisc11.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 12
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc12.sas program and select "Batch Submit".

3. Review the cdisc12.log file to ensure that there are no error messages.

4. Review the cdisc12.html to verify the comment following capture case number 10:

   • Dataset AE has comments "Data name matches guidelines but not data label which is: Adverse Events"

5. Compare the log and html file generated including: cdisc12.log and cdisc12.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 13
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc13.sas program and select "Batch Submit".

3. Review the cdisc13.log file to ensure that there are no error messages.

4. Review the cdisc13.html to verify the comment following capture case number 11:

   • Dataset NOTDM has comments "Data label matches guidelines but not data name"

5. Compare the log and html file generated including: cdisc13.log and cdisc13.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 14
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc14.sas program and select "Batch Submit".

3. Review the cdisc14.log file to ensure that there are no error messages.

4. Review the cdisc14.html to verify that the variables from WRONG1 to WRONG62 capture case number 12. The comment such as:

   • Variable label matches the text: POSITION, but variable does not contain abbreviation: POS

   • Variable label matches the text: RESULT, but variable does not contain abbreviation: RES

5. Compare the log and html file generated including: cdisc14.log and cdisc14.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 15
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".  

2. Right mouse click on the cdisc15.sas program and select "Batch Submit".

3. Review the cdisc15.log file to ensure that there are no error messages.

4. Review the cdisc15.html to verify the comment following capture case number 13 for "aeseq" variable:

   • Sequence variable is not unique by USUBJID

5. Compare the log and html file generated including: cdisc15.log and cdisc15.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 16
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc16.sas program and select "Batch Submit".

3. Review the cdisc16.log file and verify that there are no error messages.

4. Review the cdisc16.html to verify the comments following capture case number 14:

   • Dataset variable has comments:
     The word: "dataset" within the label has casing irregularities.
     The word: "labels" within the label has casing irregularities."
      

   • Variable var2, var3, var4, and var5 have comments in turn:
     The word: "variable" within the label has casing irregularities.
     The word: "VarIabLe" within the label has casing irregularities.
     The word: "VARIABLE" within the label has casing irregularities.
     The word: "var5" within the label has casing irregularities.

5. Compare the log and html file generated including: cdisc16.log and cdisc16.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 17
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc17.sas program and select "Batch Submit".

3. Review the cdisc17.log file and verify that there are no error messages.

4. Review the cdisc17.html to verify the comments following that capture case number 15 for the dataset from AE to VS. The comments such as:

   • STUDYID in the observation 1 has missing value.

   • USUBJID in the observation 1 has missing value.

   • AESEQ in the observation 1 has missing value.

5. Compare the log and html file generated including: cdisc17.log and cdisc17.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 18
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc18.sas program and select "Batch Submit".

3. Review the cdisc18.log file and verify that there are no error messages.

4. Review the cdisc18.html to verify the comments following that capture case number 16:

   • For variables var1, var2, var3, var4 have comments "Variables VAR1, VAR4 and variables VAR2, VAR3 have same parenthesis values, but they are not same types or lengths".

   • For variables var5, var6 have comments "Variable VAR5 and variable VAR6 have same parenthesis values, but they are not same types or lengths".

   • For variables var7, var8 have comments "Variable VAR7 and variable VAR8 have same parenthesis values, but they are not same types or lengths".

5. Compare the log and html file generated including: cdisc18.log and cdisc18.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 19
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc19.sas program and select "Batch Submit".

3. Review the cdisc19.log file and verify that there are no error messages.

4. Review the cdisc19.html to verify the comment following that capture case number 19:

   • Data has zero rows and therefore contains no data.

5. Compare the log and html file generated including: cdisc19.log and cdisc19.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 20
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc21.sas program and select "Batch Submit".

3. Review the cdisc21.log file and verify that there are no error messages.

4. Review the cdisc21.html to verify the comment following that capture case number 21:

   • Subject '789' has no records with a value of 'Y' in the baseline flag variable (QSBLFL).

5. Compare the log and html file generated including: cdisc21.log and cdisc21.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 21
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc22.sas program and select "Batch Submit".

3. Review the cdisc22.log file and verify that there are no error messages.

4. Review the cdisc22.html to verify the comments following that capture case number 22:

   • The LBTESTCD which is named "test2" has corresponding LBSTRESU which is not consistent across all records.

   • The LBTESTCD which is named "test3" has corresponding LBSTRESU which is not consistent across all records.

5. Compare the log and html file generated including: cdisc22.log and cdisc22.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 22
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc23.sas program and select "Batch Submit".

3. Review the cdisc23.log file and verify that there are no error messages.

4. Review the cdisc23.html to verify the comments following that capture case number 23:

   • In observation 6 has a value for the Preferred Term (AETERM) which is not found in the MedDRA dictionary (AEDECOD).

   • In observations 10 through 11 have values for the Preferred Term (AETERM) which is not found in the MedDRA dictionary (AEDECOD).

5. Compare the log and html file generated including: cdisc23.log and cdisc23.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 23
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc24.sas program and select "Batch Submit".

3. Review the cdisc24.log file and verify that there are no error messages.

4. Review the cdisc24.html to verify the comments following that capture case number 24:

   • In observation 11, AESER = 'Y' but none of the following: AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE equals 'Y'.

   • In observation 5, AESER = 'Y' but none of the following: AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE equals 'Y'.

5. Compare the log and html file generated including: cdisc24.log and cdisc24.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 24
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc25.sas program and select "Batch Submit".

3. Review the cdisc25.log file and verify that there are no error messages.

4. Review the cdisc25.html to verify the comments following that capture case number 25:

   • In observation 1, there is a condition where both QSORRES and QSSTAT have a value or both are null.

   • In observation 4, there is a condition where both QSORRES and QSSTAT have a value or both are null.

5. Compare the log and html file generated including: cdisc25.log and cdisc25.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 25
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc26.sas program and select "Batch Submit".

3. Review the cdisc26.log file and verify that there are no error messages.

4. Review the cdisc26.html to verify the comments following that capture case number 26:

   • In observation 2, there is a case where the variable VISITNUM contains a format with more than two decimal places.

   • In observation 6, there is a case where the variable VISITNUM contains a format with more than two decimal places.

5. Compare the log and html file generated including: cdisc26.log and cdisc26.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 26
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc27.sas program and select "Batch Submit".

3. Review the cdisc27.log file and verify that there are no error messages.

4. Review the cdisc27.html to verify the comments following that capture case number 27:

   • In observation 2, the value for variable ARMCD equals 'SCRNFAIL' but the corresponding variable ARM does not equal 'Screen Failure', and vice versa.

   • In observation 4, the value for variable ARMCD equals 'SCRNFAIL' but the corresponding variable ARM does not equal 'Screen Failure', and vice versa.

5. Compare the log and html file generated including: cdisc27.log and cdisc27.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 27
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc28.sas program and select "Batch Submit".

3. Review the cdisc28.log file and verify that there are no error messages.

4. Review the cdisc28.html to verify the comments following that capture case number 28:

   • In observation 3, the value for variable ARMCD equals 'SCRNFAIL' but the corresponding variable ARM not equals 'Screen Failure', and vice versa.

   • In observation 8, the value for variable ARMCD equals 'SCRNFAIL' but the corresponding variable ARM not equals 'Screen Failure', and vice versa.

5. Compare the log and html file generated including: cdisc28.log and cdisc28.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 28
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc29.sas program and select "Batch Submit".

3. Review the cdisc29.log file and verify that there are no error messages.

4. Review the cdisc29.html to verify the comment following that capture case number 29:

   • In observation 2, the value for variable SVSTDY is greater than that found in SVENDY.

5. Compare the log and html file generated including: cdisc29.log and cdisc29.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 29
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc30.sas program and select "Batch Submit".

3. Review the cdisc30.log file and verify that there are no error messages.

4. Review the cdisc30.html to verify the comment following that capture case number 30:

   • In observation 1, the value for variable SVSTDTC is greater than for SVENDTC.

5. Compare the log and html file generated including: cdisc30.log and cdisc30.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 30
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc31.sas program and select "Batch Submit".

3. Review the cdisc31.log file and verify that there are no error messages.

4. Review the cdisc31.html to verify the comment following that capture case number 31:

   • In observation 5, the value for variable QSBLFL is neither 'Y' nor null.

5. Compare the log and html file generated including: cdisc31.log and cdisc31.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 31
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc32.sas program and select "Batch Submit".

3. Review the cdisc32.log file and verify that there are no error messages.

4. Review the cdisc32.html to verify the comment following that capture case number 32:

   • In observation 5, the value for variable QSDRVFL is neither 'Y' nor null.

5. Compare the log and html file generated including: cdisc32.log and cdisc32.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 32
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc33.sas program and select "Batch Submit".

3. Review the cdisc33.log file and verify that there are no error messages.

4. Review the cdisc33.html to verify the comment following that capture case number 33:

   • In observation 7, the values for variable AEENRF does not contain one of the following: BEFORE','DURING','AFTER' ,'DURING/AFTER','U'.

5. Compare the log and html file generated including: cdisc33.log and cdisc33.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 33
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc34.sas program and select "Batch Submit".

3. Review the cdisc34.log file and verify that there are no error messages.

4. Review the cdisc34.html to verify the comment following that capture case number 34:

   • In observation 7, the value for variable LBFAST does not contain one of the following: 'Y','N','U'.

5. Compare the log and html file generated including: cdisc34.log and cdisc34.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 34
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc35.sas program and select "Batch Submit".

3. Review the cdisc35.log file and verify that there are no error messages.

4. Review the cdisc35.html to verify the comment following that capture case number 35:

   • In observation 5, the value for variable CEOCCUR does not contain one of the following: 'Y','N'.

5. Compare the log and html file generated including: cdisc35.log and cdisc35.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 35
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc36.sas program and select "Batch Submit".

3. Review the cdisc36.log file and verify that there are no error messages.

4. Review the cdisc36.html to verify the comment following that capture case number 36:

   • In observation 5, the value for variable QSSTAT is neither null nor NOT DONE.

5. Compare the log and html file generated including: cdisc36.log and cdisc36.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 36
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc37.sas program and select "Batch Submit".

3. Review the cdisc37.log file and verify that there are no error messages.

4. Review the cdisc37.html to verify the comment following that capture case number 37:

   • In observation 1, the value for variable CESTRF does not contain ('BEFORE','DURING','AFTER').

5. Compare the log and html file generated including: cdisc37.log and cdisc37.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 37
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc38.sas program and select "Batch Submit".

3. Review the cdisc38.log file and verify that there are no error messages.

4. Review the cdisc38.html to verify the comment following that capture case number 38:

   • In observation 4, the value for variable EXDOSE does not contain null but is less than 0.

5. Compare the log and html file generated including: cdisc38.log and cdisc38.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 38
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc39.sas program and select "Batch Submit".

3. Review the cdisc39.log file and verify that there are no error messages.

4. Review the cdisc39.html to verify the comment following that capture case number 39:

   • In observation 1, the value for variable EXDUR is less than 0.

5. Compare the log and html file generated including: cdisc39.log and cdisc39.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 39
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc40.sas program and select "Batch Submit".

3. Review the cdisc40.log file and verify that there are no error messages.

4. Review the cdisc40.html to verify the comment following that capture case number 40:

   • In observation 4, the value for variable QSDRVFL equals 'Y' but the value for variable QSORRES is null.

5. Compare the log and html file generated including: cdisc40.log and cdisc40.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 40
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc41.sas program and select "Batch Submit".

3. Review the cdisc41.log file and verify that there are no error messages.

4. Review the cdisc41.html to verify the comment following that capture case number 41:

   • In observation 4, the value for variable QSDRVFL equals 'Y' but the value for variable QSSTRESC is null.

5. Compare the log and html file generated including: cdisc41.log and cdisc41.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 41
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc42.sas program and select "Batch Submit".

3. Review the cdisc42.log file and verify that there are no error messages.

4. Review the cdisc42.html to verify the comment following that capture case number 42:

   • In observation 4, the value for variable QSTEST is greater than 40 characters.

5. Compare the log and html file generated including: cdisc42.log and cdisc42.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 42
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc43.sas program and select "Batch Submit".

3. Review the cdisc43.log file and verify that there are no error messages.

4. Review the cdisc43.html to verify the comments following that capture case number 43:

   • In observation 2, the value for variable QSTESTCD greater than 8 characters.

   • In observation 3, the value for variable QSTESTCD starts with a number.

   • In observation 4, the value for variable QSTESTCD starts with a number.

5. Compare the log and html file generated including: cdisc43.log and cdisc43.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 43
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc44.sas program and select "Batch Submit".

3. Review the cdisc44.log file and verify that there are no error messages.

4. Review the cdisc44.html to verify the comment following that capture case number 44:

   • In observation 4, the value for variable TSPARM is greater than 40 characters.

5. Compare the log and html file generated including: cdisc44.log and cdisc44.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 44
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc45.sas program and select "Batch Submit".

3. Review the cdisc45.log file and verify that there are no error messages.

4. Review the cdisc45.html to verify the comments following that capture case number 45:

   • In observation 3 through 5, the value for variable TSPARMCD greater than 8 characters.

5. Compare the log and html file generated including: cdisc45.log and cdisc45.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 45
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc46.sas program and select "Batch Submit".

3. Review the cdisc46.log file and verify that there are no error messages.

4. Review the cdisc46.html to verify the comment following that capture case number 46:

   • In observation 5, the value for variables CEENDTC and CEENRF are both null.

5. Compare the log and html file generated including: cdisc46.log and cdisc46.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 46
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc47.sas program and select "Batch Submit".

3. Review the cdisc47.log file and verify that there are no error messages.

4. Review the cdisc47.html to verify the comment following that capture case number 47:

   • In observation 5, the value for variables CESTDTC and CESTRF are both null.

5. Compare the log and html file generated including: cdisc47.log and cdisc47.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 47
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc48.sas program and select "Batch Submit".

3. Review the cdisc48.log file and verify that there are no error messages.

4. Review the cdisc48.html to verify the comment following that capture case number 48:

   • In observation 3 the value for variable EXELTM is less than 0.

5. Compare the log and html file generated including: cdisc48.log and cdisc48.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 48
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc49.sas program and select "Batch Submit".

3. Review the cdisc49.log file and verify that there are no error messages.

4. Review the cdisc49.html to verify the comment following that capture case number 49:

   • In observation 6, the value for variable QSEVLINT is less than 0.

5. Compare the log and html file generated including: cdisc49.log and cdisc49.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 49
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc50.sas program and select "Batch Submit".

3. Review the cdisc50.log file and verify that there are no error messages.

4. Review the cdisc50.html to verify the comment following that capture case number 50:

   • In observation 4, the variable AETOXGR (Standard Toxicity Grade) contains an invalid number.

5. Compare the log and html file generated including: cdisc50.log and cdisc50.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 50
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc51.sas program and select "Batch Submit".

3. Review the cdisc51.log file and verify that there are no error messages.

4. Review the cdisc51.html to verify the comments following that capture case number 51:

   • In observation 3 through 4, the value for variable AEREASND has a non missing value while variable AESTAT has a missing value.

5. Compare the log and html file generated including: cdisc51.log and cdisc51.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 51
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc52.sas program and select "Batch Submit".

3. Review the cdisc52.log file and verify that there are no error messages.

4. Review the cdisc52.html to verify the comment following that capture case number 52:

   • In observation 4, the value for variable LBDTC has a missing value while the variable LBENDTC has a non missing values.

5. Compare the log and html file generated including: cdisc52.log and cdisc52.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 52
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc53.sas program and select "Batch Submit".

3. Review the cdisc53.log file and verify that there are no error messages.

4. Review the cdisc53.html to verify the comments following that capture case number 53:

   • In observation 2 through 3, the value for variable LBDTC is greater than the value for variable LBENDTC.

5. Compare the log and html file generated including: cdisc53.log and cdisc53.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 53
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc54.sas program and select "Batch Submit".

3. Review the cdisc54.log file and verify that there are no error messages.

4. Review the cdisc54.html to verify the comment following that capture case number 54:

   • In observation 4, the value for variable LBSTRESC has a missing value while the variable LBORRESU has a non missing values.

5. Compare the log and html file generated including: cdisc54.log and cdisc54.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 54
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc55.sas program and select "Batch Submit".

3. Review the cdisc55.log file and verify that there are no error messages.

4. Review the cdisc55.html to verify the comment following that capture case number 55:

   • In observation 3, the value for variable LBORRESU has a non missing value while variable LBORRES has a missing value.

5. Compare the log and html file generated including: cdisc55.log and cdisc55.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 55
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc56.sas program and select "Batch Submit".

3. Review the cdisc56.log file and verify that there are no error messages.

4. Review the cdisc56.html to verify the comments following that capture case number 56:

   • In observation 2 through 3, the Normal Range Upper Limit-Standard Units must be greater than or equal to Normal Range Lower Limit-Standard Units.

5. Compare the log and html file generated including: cdisc56.log and cdisc56.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 56
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc57.sas program and select "Batch Submit".

3. Review the cdisc57.log file and verify that there are no error messages.

4. Review the cdisc57.html to verify the comment following that capture case number 57:

   • In observation 1, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.

5. Compare the log and html file generated including: cdisc57.log and cdisc57.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 57
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc58.sas program and select "Batch Submit".

3. Review the cdisc58.log file and verify that there are no error messages.

4. Review the cdisc58.html to verify the comment following that capture case number 58:

   • In observation 2, the value for variable LBSTRESU has a non missing value while variable LBSTRESC has a missing value.

5. Compare the log and html file generated including: cdisc58.log and cdisc58.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 58
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc59.sas program and select "Batch Submit".

3. Review the cdisc59.log file and verify that there are no error messages.

4. Review the cdisc59.html to verify the comment following that capture case number 59:

   • In observation 4, the value for variable MHSTDTC has a missing value while the variable MHENDTC has a non missing values.

5. Compare the log and html file generated including: cdisc59.log and cdisc59.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 59
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc60.sas program and select "Batch Submit".

3. Review the cdisc60.log file and verify that there are no error messages.

4. Review the cdisc60.html to verify the comments following that capture case number 60:

   • In observation 2 through 4, the value for variable MHTPT has a missing value while the variable MHTPTNUM has a non missing values.

5. Compare the log and html file generated including: cdisc60.log and cdisc60.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 60
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc61.sas program and select "Batch Submit".

3. Review the cdisc61.log file and verify that there are no error messages.

4. Review the cdisc61.html to verify the comments following that capture case number 61:

   • In observation 3 through 4, the value for variable MHTPTNUM has a missing value while the variable MHTPT has a non missing values.

5. Compare the log and html file generated including: cdisc61.log and cdisc61.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 61
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc62.sas program and select "Batch Submit".

3. Review the cdisc62.log file and verify that there are no error messages.

4. Review the cdisc62.html to verify the comment following that capture case number 62:

   • In observation 3, the value for variable MHTPTREF has a missing value while the variable MHELTM has a non missing values.

5. Compare the log and html file generated including: cdisc62.log and cdisc62.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 62
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc63.sas program and select "Batch Submit".

3. Review the cdisc63.log file and verify that there are no error messages.

4. Review the cdisc63.html to verify the comment following that capture case number 63:

   • In observation 2, the value for variable CMDOSU has a missing value while the variable CMDOSE has a non missing values.

5. Compare the log and html file generated including: cdisc63.log and cdisc63.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 63
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc64.sas program and select "Batch Submit".

3. Review the cdisc64.log file and verify that there are no error messages.

4. Review the cdisc64.html to verify the comment following that capture case number 64:

   • In observation 2, the value for variable LBSTRESC has a missing value while the variable LBORRES has a non missing values.

5. Compare the log and html file generated including: cdisc64.log and cdisc64.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 64
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc65.sas program and select "Batch Submit".

3. Review the cdisc65.log file and verify that there are no error messages.

4. Review the cdisc65.html to verify the comment following that capture case number 65:

   • In observation 5, for All domains, this identifies records where values are not found in the study-specific codelist attached to a variable.

5. Compare the log and html file generated including: cdisc65.log and cdisc65.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 65
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc66.sas program and select "Batch Submit".

3. Review the cdisc66.log file and verify that there are no error messages.

4. Review the cdisc66.html to verify the comment following that capture case number 66, it such as:

   • In observation 1 through 3 the value for Study Day of Visit/Collection/Exam equals 0.

5. Compare the log and html file generated including: cdisc66.log and cdisc66.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 66
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc67a.sas program and select "Batch Submit".

3. Review the cdisc67a.log file and verify that there are no error messages.

4. Review the cdisc67a.html to verify the comment following that capture case number 67:

   • For AE domain, the Flag Variable for 'Treatment Emergent AE' contains an invalid derivation.

5. Compare the log and html file generated including: cdisc67a.log and cdisc67a.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 67
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc67b.sas program and select "Batch Submit".

3. Review the cdisc67b.log file and verify that there are no error messages.

4. Review the cdisc67b.html to verify the comment is not capturing the any case number 67.

5. Compare the log and html file generated including: cdisc67b.log and cdisc67b.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 68
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc68.sas program and select "Batch Submit".

3. Review the cdisc68.log file and verify that there are no error messages.

4. Review the cdisc68.html to verify the comment following that capture case number 68:

   • For LB domain, the Flag Variable for 'Clinically Significant Lab' contains an invalid derivation.

5. Compare the log and html file generated including: cdisc68.log and cdisc68.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 69
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc69.sas program and select "Batch Submit".

3. Review the cdisc69.log file and verify that there are no error messages.

4. Review the cdisc69.html to verify the comment following that capture case number 69:

   • For VS domain, the Flag Variable for 'Clinically Significant Vitals' contains an invalid derivation.

5. Compare the log and html file generated including: cdisc69.log and cdisc69.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 70
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc70.sas program and select "Batch Submit".

3. Review the cdisc70.log file and verify that there are no error messages.

4. Review the cdisc70.html to verify the comment following that capture case number 70:

   • For Supplemental Qualifiers domains, a domain appears to contain supplemental qualifier data but does not contain the Unique Subject Identifier variable.

5. Compare the log and html file generated including: cdisc70.log and cdisc70.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 71
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc71.sas program and select "Batch Submit".

3. Review the cdisc71.log file and verify that there are no error messages.

4. Review the cdisc71.html to verify the comments following that capture case number 71:

   • The variable 'TEST' is not present in (study specific) description file for DM domain.

   • The variable 'TEST1' is not present in (study specific) description file for DM domain.

5. Compare the log and html file generated including: cdisc71.log and cdisc71.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 72
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc72.sas program and select "Batch Submit".

3. Review the cdisc72.log file and verify that there are no error messages.

4. Review the cdisc72.html to verify the comment following that capture case number 72:

   • The variable USUBJID contains a value '111' which is not found in the Demographics domain.

5. Compare the log and html file generated including: cdisc72.log and cdisc72.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 73
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc73.sas program and select "Batch Submit".

3. Review the cdisc73.log file and verify that there are no error messages.

4. Review the cdisc73.html to verify the comment following that capture case number 73:

   • The values for variables: USUBJID+VISITNUM+VISIT, '102+4+WEEK 2' is not found in the SV domain.

5. Compare the log and html file generated including: cdisc73.log and cdisc73.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 74
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc74.sas program and select "Batch Submit".

3. Review the cdisc74.log file and verify that there are no error messages.

4. Review the cdisc74.html to verify the comments following that capture case number 74:

   • The DM domain contains a variable ARMCD '' which is not found in the TA domain.

   • The DM domain contains a variable ARMCD 'test' which is not found in the TA domain.

5. Compare the log and html file generated including: cdisc74.log and cdisc74.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 75
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc75.sas program and select "Batch Submit".

3. Review the cdisc75.log file and verify that there are no error messages.

4. Review the cdisc75.html to verify the comment following that capture case number 75:

   • This required value for variable ETCD = 'SCREEN' not found in the TE domain.

5. Compare the log and html file generated including: cdisc75.log and cdisc75.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 76
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc76.sas program and select "Batch Submit".

3. Review the cdisc76.log file and verify that there are no error messages.

4. Review the cdisc76.html to verify the comment following that capture case number 76:

   • This required value for variable IETESTCD = 'INCL03' not found in the TI domain.

5. Compare the log and html file generated including: cdisc76.log and cdisc76.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 77
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc77.sas program and select "Batch Submit".

3. Review the cdisc77.log file and verify that there are no error messages.

4. Review the cdisc77.html to verify the comments following that capture case number 77:

   • In observations 6 through 7, the DS domain contains a Sequence Number for subjects that are not found in DM domain.

5. Compare the log and html file generated including: cdisc77.log and cdisc77.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 78
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc78.sas program and select "Batch Submit".

3. Review the cdisc78.log file and verify that there are no error messages.

4. Review the cdisc78.html to verify the comments following that capture case number 78:

   • In observations 6 through 7 for the EX domain, the Sequence Number for subjects are not found in DM domain.

5. Compare the log and html file generated including: cdisc78.log and cdisc78.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 79
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc79.sas program and select "Batch Submit".

3. Review the cdisc79.log file and verify that there are no error messages.

4. Review the cdisc79.html to verify the comments following that capture case number 79:

   • In observations 2 through 3, the value for variables: ARMCD and ARM are not found in the TA domain.

5. Compare the log and html file generated including: cdisc79.log and cdisc79.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 80
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc80.sas program and select "Batch Submit".

3. Review the cdisc80.log file and verify that there are no error messages.

4. Review the cdisc80.html to verify the comment following that capture case number 80:

   • In observation 5, the value for variable RDOMAIN named 'INV' references to an unknown related domain.

5. Compare the log and html file generated including: cdisc80.log and cdisc80.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 81
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc81.sas program and select "Batch Submit".

3. Review the cdisc81.log file and verify that there are no error messages.

4. Review the cdisc81.html to verify the comment following that capture case number 81:

   • In observation 3, the Related Record domain reference to an unknown related domain.

5. Compare the log and html file generated including: cdisc81.log and cdisc81.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 82
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc82.sas program and select "Batch Submit".

3. Review the cdisc82.log file and verify that there are no error messages.

4. Review the cdisc82.html to verify the comment following that capture case number 82:

   • In observation 3, the Supplemental Qualifiers domain reference to an unknown related domain.

5. Compare the log and html file generated including: cdisc82.log and cdisc82.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 83
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc83.sas program and select "Batch Submit".

3. Review the cdisc83.log file and verify that there are no error messages.

4. Review the cdisc83.html to verify the comments following that capture case number 83:

   • In observation 1, the Related Records domain reference to a key variable that was not defined in the target domain.

   • In observation 2, the Related Records domain reference to a key variable that was not defined in the target domain.

5. Compare the log and html file generated including: cdisc83.log and cdisc83.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 84
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc84.sas program and select "Batch Submit".

3. Review the cdisc84.log file and verify that there are no error messages.

4. Review the cdisc84.html to verify the comments following that capture case number 84:

   • In observation 1, the Supplemental Qualifiers domain reference to a key variable that was not defined in the target domain.

   • In observation 2, the Supplemental Qualifiers domain reference to a key variable that was not defined in the target domain.

5. Compare the log and html file generated including: cdisc84.log and cdisc84.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 85
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc85.sas program and select "Batch Submit".

3. Review the cdisc85.log file and verify that there are no error messages.

4. Review the cdisc85.html to verify the comments following that capture case number 85:

   • In observation 1, the Related Records domain referenced a record that does not exist in the target domain.

   • In observation 2, the Related Records domain referenced a record that does not exist in the target domain.

   • In observation 3, the Related Records domain referenced a record that does not exist in the target domain.

5. Compare the log and html file generated including: cdisc85.log and cdisc85.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 86
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc86.sas program and select "Batch Submit".

3. Review the cdisc86.log file and verify that there are no error messages.

4. Review the cdisc86.html to verify the comments following that capture case number 86:

   • In observation 1, the Supplemental Qualifiers domain referenced a record that does not exist in the target domain.

   • In observation 2, the Supplemental Qualifiers domain referenced a record that does not exist in the target domain.

   • In observation 3, the Supplemental Qualifiers domain referenced a record that does not exist in the target domain.

5. Compare the log and html file generated including: cdisc86.log and cdisc86.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 87
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc87.sas program and select "Batch Submit".

3. Review the cdisc87.log file and verify that there are no error messages.

4. Review the cdisc87.html to verify the comment following that capture case number 87:

   • In observation 2, there was a non-unique value for variable USUBJID.

5. Compare the log and html file generated including: cdisc87.log and cdisc87.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 88
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc88.sas program and select "Batch Submit".

3. Review the cdisc88.log file and verify that there are no error messages.

4. Review the cdisc88.html to verify the comment following that capture case number 88:

   • In observation 2, there was an invalid AGE value.

5. Compare the log and html file generated including: cdisc88.log and cdisc88.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 89
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc89.sas program and select "Batch Submit".

3. Review the cdisc89.log file and verify that there are no error messages.

4. Review the cdisc89.html to verify the comment following that capture case number 89:

   • In observation 1, there was an invalid SEX value.

5. Compare the log and html file generated including: cdisc89.log and cdisc89.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 90
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc90.sas program and select "Batch Submit".

3. Review the cdisc90.log file and verify that there are no error messages.

4. Review the cdisc90.html to verify the comments following that capture case number 90:

   • In observation 2 through 3, there was an invalid value for variable COUNTRY.

5. Compare the log and html file generated including: cdisc90.log and cdisc90.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 91
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc91.sas program and select "Batch Submit".

3. Review the cdisc91.log file and verify that there are no error messages.

4. Review the cdisc91.html to verify the comment following that capture case number 91:

   • In observation 1, there was an invalid value for variable AESER.

5. Compare the log and html file generated including: cdisc91.log and cdisc91.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 92
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc92.sas program and select "Batch Submit".

3. Review the cdisc92.log file and verify that there are no error messages.

4. Review the cdisc92.html to verify the comment following that capture case number 92:

   • In observation 1, there was an invalid value for variable AESER.

5. Compare the log and html file generated including: cdisc92.log and cdisc92.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 93
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc93.sas program and select "Batch Submit".

3. Review the cdisc93.log file and verify that there are no error messages.

4. Review the cdisc93.html to verify the comment following that capture case number 93:

   • In observation 1, there was an invalid value for variable AESDISAB.

5. Compare the log and html file generated including: cdisc93.log and cdisc93.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 94
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc94.sas program and select "Batch Submit".

3. Review the cdisc94.log file and verify that there are no error messages.

4. Review the cdisc94.html to verify the comment following that capture case number 94:

   • In observation 1, there was an invalid value for variable AESDTH.

5. Compare the log and html file generated including: cdisc94.log and cdisc94.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 95
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc95.sas program and select "Batch Submit".

3. Review the cdisc95.log file and verify that there are no error messages.

4. Review the cdisc95.html to verify the comment following that capture case number 95:

   • In observation 1, there was an invalid value for variable AESHOSP.

5. Compare the log and html file generated including: cdisc95.log and cdisc95.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 96
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc96.sas program and select "Batch Submit".

3. Review the cdisc96.log file and verify that there are no error messages.

4. Review the cdisc96.html to verify the comment following that capture case number 96:

   • In observation 1, there was an invalid value for variable AESLIFE.

5. Compare the log and html file generated including: cdisc96.log and cdisc96.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 97
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc97.sas program and select "Batch Submit".

3. Review the cdisc97.log file and verify that there are no error messages.

4. Review the cdisc97.html to verify the comments following that capture case number 97:

   • In observation 1, there was an invalid value for variable: IECAT.

   • In observation 3, there was an invalid value for variable: IECAT.

   • The standard term used "NA" is invalid for variable IESTRESC. The list of standard preferred terms are found at NCI Site.

   • The standard term used "U" is invalid for variable IESTRESC. The list of standard preferred terms are found at NCI Site.

5. Compare the log and html file generated including: cdisc97.log and cdisc97.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 98
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc98.sas program and select "Batch Submit".

3. Review the cdisc98.log file and verify that there are no error messages.

4. Review the cdisc98.html to verify the comment following that capture case number 98:

   • In observation 1 there was an invalid value for variable AECONTRT.

5. Compare the log and html file generated including: cdisc98.log and cdisc98.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 99
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc99.sas program and select "Batch Submit".

3. Review the cdisc99.log file and verify that there are no error messages.

4. Review the cdisc99.html to verify the comment following that capture case number 99:

   • In observation 1, there was an invalid value for variable AESCAN.

5. Compare the log and html file generated including: cdisc99.log and cdisc99.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 100
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc100.sas program and select "Batch Submit".

3. Review the cdisc100.log file and verify that there are no error messages.

4. Review the cdisc100.html to verify the comment following that capture case number 100:

   • The observation 1 has an invalid AESOD value.

5. Compare the log and html file generated including: cdisc100.log and cdisc100.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 101
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc101.sas program and select "Batch Submit".

3. Review the cdisc101.log file and verify that there are no error messages.

4. Review the cdisc101.html to verify the comments following that capture case number 101:

   • The observation 3 has an invalid AGEU value.

   • The observation 5 has an invalid AGEU value.

5. Compare the log and html file generated including: cdisc101.log and cdisc101.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 102
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc102.sas program and select "Batch Submit".

3. Review the cdisc102.log file and verify that there are no error messages.

4. Review the cdisc102.html to verify the comment following that capture case number 102:

   • The observation 6 has an invalid IEORRES value.

5. Compare the log and html file generated including: cdisc102.log and cdisc102.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 103
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc103.sas program and select "Batch Submit".

3. Review the cdisc103.log file and verify that there are no error messages.

4. Review the cdisc103.html to verify the comment following that capture case number 103:

   • The observation 3 has an invalid IESTRESC value.

5. Compare the log and html file generated including: cdisc103.log and cdisc103.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 104
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc104.sas program and select "Batch Submit".

3. Review the cdisc104.log file and verify that there are no error messages.

4. Review the cdisc104.html to verify the comments following that capture case number 104:

   • The variable: IEORRES (.) is not equal to variable: IESTRESC (.) in observation 1.

   • The variable: IEORRES (.) is not equal to variable: IESTRESC (.) in observation 3.

5. Compare the log and html file generated including: cdisc104.log and cdisc104.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 105
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc105.sas program and select "Batch Submit".

3. Review the cdisc105.log file and verify that there are no error messages.

4. Review the cdisc105.html to verify the comments following that capture case number 105:

   • The observation 1 has an invalid value.

5. Compare the log and html file generated including: cdisc105.log and cdisc105.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 106
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc106.sas program and select "Batch Submit".

3. Review the cdisc106.log file and verify that there are no error messages.

4. Review the cdisc106.html to verify the comments following that capture case number 106:

   • The observation 3 has an invalid value for the variable: RFSTDTC (.).

   • The observation 6 has an invalid value for the variable: RFSTDTC (.).

5. Compare the log and html file generated including: cdisc106.log and cdisc106.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 107
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc107.sas program and select "Batch Submit".

3. Review the cdisc107.log file and verify that there are no error messages.

4. Review the cdisc107.html to verify the comments following that capture case number 107:

   • The observations 2 through 3 have invalid values for the variable: RFENDTC (.).

5. Compare the log and html file generated including: cdisc107.log and cdisc107.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 108
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc108.sas program and select "Batch Submit".

3. Review the cdisc108.log file and verify that there are no error messages.

4. Review the cdisc108.html to verify the comments following that capture case number 108:

   • The observation 3 has an invalid value for the variable: TEENRL (.) and TEDUR (.).

   • The observation 6 has an invalid value for the variable: TEENRL (.) and TEDUR (.).

5. Compare the log and html file generated including: cdisc108.log and cdisc108.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 109
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc109.sas program and select "Batch Submit".

3. Review the cdisc109.log file and verify that there are no error messages.

4. Review the cdisc109.html to verify the comments following that capture case number 109:

   • The observation 1 has an invalid value for the variable: AESDTH (.).

   • The observation 9 has an invalid value for the variable: AESDTH (.).

5. Compare the log and html file generated including: cdisc109.log and cdisc109.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 110
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc110.sas program and select "Batch Submit".

3. Review the cdisc110.log file and verify that there are no error messages.

4. Review the cdisc110.html to verify the comment following that capture case number 110:

   • The observation 4 has an invalid value for variable: AEOUT (.).

5. Compare the log and html file generated including: cdisc110.log and cdisc110.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 111
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc111.sas program and select "Batch Submit".

3. Review the cdisc111.log file and verify that there are no error messages.

4. Review the cdisc111.html to verify the comment following that capture case number 111:

   • The count for (distinct Protocol Deviation Term) is not equal to the count for ( distinct Protocol Deviation Coded Term).

5. Compare the log and html file generated including: cdisc111.log and cdisc111.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 112
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc112.sas program and select "Batch Submit".

3. Review the cdisc112.log file and verify that there are no error messages.

4. Review the cdisc112.html to verify the comments following that capture case number 112:

   • The observation 1 has an invalid value for the variable: SEUPDES (.).

   • The observation 6 has an invalid value for the variable: SEUPDES (.).

5. Compare the log and html file generated including: cdisc112.log and cdisc112.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 113
The following instructions are accomplished through Windows Explorer.

1. Navigate to the validation sub-directory named "saspgm".

2. Right mouse click on the cdisc113.sas program and select "Batch Submit".

3. Review the cdisc113.log file and verify that there are no error messages.

4. Review the cdisc113.html to verify the comment following that capture case number 113:

   • The observation 1 has an invalid value for the variable: AGEU (.).

5. Compare the log and html file generated including: cdisc113.log and cdisc113.html against the corresponding files in the benchmark area to ensure the results are the same.

Instructions 114
The following instructions are accomplished through Windows Explorer.

1. Navigate to the sub_directory named "data", rename config.sas7bdat to the name such as config_bak.sas7bdat.

2. Download the dataset _3_1_2.sas7bdat and config.sas7bdat for SDTMIG 3.1.2 model. Paste these datasets to 'data' folder in step 1.

3. Navigate to the validation sub-directory named "saspgm".

4. Right mouse click on the cdisc114.sas program and select "Batch Submit".

5. Review the cdisc114.log file and verify that there are no error messages.

6. Review the cdisc114.html to verify the comments following that capture case number 114:

   • Variable TEST does not exist in the guidelines.

7. Compare the log and html file generated including: cdisc114.log and cdisc114.html against the corresponding files in the benchmark area to ensure the results are the same.

For more information, please contact MXI .