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