Additional checks to consider
Here is a list of some of the checks we find helpful at our company in addition to the defined IR---- and R---- checks:
Number - Error Message
1 - User variable is not defined in SDTM.
2 - Variable _____ is a REQUIRED variable in this domain and should always be included in the dataset.
3 - Variable _____ is an EXPECTED variable in this domain and should always be included in the dataset.
4 - Variable is a PERMISSIBLE variable in this domain but is null for all records. If no data is anticipated, drop _____.
5 - Variable name/label matches guidelines but please modify your variable type according to CDISC specifications.
6 - Variable name/label matches guidelines but please modify your variable label/name according to CDISC specifications
7 - Variable name ending with DTC should be a character variable, not a numeric variable.
8 - Length of variable name exceeds 8.
9 - Length of variable label exceeds 40.
10 - Defined length of variable exceeds 200.
11 - Length of variable needs to be defined. (In 0 obs datasets.)
12 - Dataset is not sorted.
13 - Both VISITNUM and VISIT must be populated.
14 - All variable values must be found in the associated codelist. (Generalized from specific checks like R4043.)
15 - Matched pair(s) in DOMAIN not found in codelist pairs. (The individual values might be valid on their own, but if the pair isn't valid, then it's an issue. i.e. LBTEST = BASO and LBTESTCD = Blood Urea Nitrogen )
16 - USUBJIDs present in DOMAIN must also be present in DM.
17 - Dataset label does not match the CDISC specified label.
18 - CDISC encourages use of Subject instead of Patient or Volunteer for Labels.
19 - STUDYID value does not match STUDYID in DM domain.
20 - IDVAR value is missing in CO domain.
21 - Referenced key variable not found in target domain.
22 - Referenced record not found in target domain.
23 - ARMCD/ARM combination in DM not found in the TV domain.
24 - ARMCD/ARM combination in TA not found in the TV domain.
25 - ETCD/ELEMENT combination in TA not found in the TE domain.
26 - ETCD/ELEMENT combination in SE not found in the TE domain.
27 - VISITNUM/VISIT/VISITDY combination in SV not found in the TV domain.
28 - IETESTCD/IETEST/IECAT combination in IE not found in the TI domain.
29 - EPOCH value in _____ not found in the TA domain.
30 - TAETORD value in _____ not found in the TA domain.
Thanks,
Diane
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Metadata Only Check
I would like to run the validation for metadata checks only. I want to make sure that our vendors are providing us with the correct variable names, labels etc.