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ADaM Checks with Publisher ID TBD+
Look to the description field of the published Pinnacle rules
Whether you look at the .xml document directly or in the browser. Or run an ADaM validation and look at the generated list of rules in the rule tab, you need only read the description. They came from the ADaM and ADAE IG 1.0. Do you disagree with any of them ? PMDA also published these. I have suggested them to be included with the CDISC ADaM rules over the past few years but they have not been added.
AD1011 | Secondary variable Variable is populated but its primary variable * is not populated | In a pair of corresponding character and numeric variables (%Variable.1% and %Variable%) the primary or most commonly used variable must be populated if its secondary variable describing it is populated. Exceptions:*FN,TRTPN,TRT01PN,PARAMN,AVALC,BASEC. Corresponding character and numeric values must also have a one to one mapping consistency when the primary variable is populated, which are addressed in other rules. This rule is expected to be added to CDISC ADaM Validation checks in v1.3. |
AD1012 | Secondary variable is present but its primary variable is not present | In a pair of corresponding character and numeric variables, the primary or most commonly used variable must be present if its secondary version describing it (*N or *C) is present. This is the generic rule to capture all instances. Specific rules 64,66,70,75,97,201 exist for other variables. PARAM and TRTP are required regardless of the presence of their N variable. Exceptions: [AVAL,AVALC] (refer to AD0198) and [BASE,BASEC]. This rule is expected to be added to CDISC ADaM Validation checks in v1.3. ADaM IG v1.0 p.10. |
AD1015 | APHASE is present but APERIOD is not present | APHASE generally is a higher-level categorization of APERIOD. APHASE Does not replace APERIOD because APERIOD provides the indexing for the TRxx and APxx variables. ADaM IG v1.0 p.25. |
AD1018 | Illegal variable name: zz is not in [01-99] for ANLzzFL/FN | For ANLzzFL and ANLzzFN (Analysis Record Flag), 'zz' is an index for the zzth record selection algorithm where 'zz' is must be in [01-99]. Similar to CDISC ADaM Validation Checks No. 299-303. ADaM IG v1.0 p.11. |
AD1019 | Illegal variable name: xx is not in [01-99] for an ADSL trial date | For ADSL Trial Dates xx of form TRxx... and APxx..., xx must be the treatment period (01 to 99). This rule covers 20 distinct variable forms listed in ADSL. It's anticipated that the CDISC ADaM Validation team will release 20 new rules to cover this scenario. |
AD9999 | Dataset -- not validated | Validation is defined only for ADSL, BDS, BDS-TTE and ADAE datasets. Other dataset structures are not currently supported. The ADaM team is working on a specification for a more general structure supporting analysis of incidence data, such as interventions and events. |
Take for example AD1018 and AD1019. CDISC would typically published 20 rules to cover these. To date, they have not. But how could you argue that xx should not be in 01 to 99, when the IG explicity says this is the valid value for that fragment ? I first suggested this to the team in April 2013. AD1011 and AD1012 also seem very logical.
Meaning | DT | TM | DTM | DTF (Impute) | TMF (Impute) |
First TRT in Period 01 | TRxxSDT | TRxxSTM | TRxxSDTM | TRxxSDTF | TRxxSTMF |
Last TRT in Period 01 | TRxxEDT | TRxxETM | TRxxEDTM | TRxxEDTF | TRxxETMF |
Period 01 Start | APxxSDT | APxxSTM | APxxSDTM | APxxSDTF | APxxSTMF |
Period 01 End | APxxEDT | APxxETM | APxxEDTM | APxxEDTF | APxxETMF |
The only real "controversial" one could be AD1015. But that is merely a WARNING, whereas all the others (including CDISC ADaM rules) are hard ERRORS. So there should not be a great concern if you include APHASE and have good reason for not including APERIOD. Page 48 of the ADAE IG 1.0 shows a good example of APHASE and APERIOD: http://www.cdisc.org/system/files/all/standard_category/application/pdf/adam_ae_final_v1.pdf.
