1. Some Considerations When Designing ADaM Datasets Italian CDISC UN Day - Milan 27th October Antonio Valenti Principal Statistical Programmer CROS NT - Verona

2. Content Disclaimer
All content included in this presentation is for informational purposes only. These are from personal notes taken during the attendance of the webinar in reference.
Please refer to the original presentation and to the latest published standards documents for the most authoritative implementation information.

3. Reference CDISC Members Only Mini-Training Series
Some Considerations When Designing ADaM Datasets
Nate Freimark, Vice President -Clinical Programming and Date Standards, The Griesser Group
CDISC Webinar 09MAR2017

4. Overview General concepts ADSL related tips &FAQ BDS related tips &FAQ
OCCDS related tips &FAQ

5. General #1 Variables selection
Just because a variable is defined in the ADaMIG does not mean it has to be created in an/all ADaM datasets:
SITEID/SUBJID in all BDS datasets
TM and DTM variables when time is missing
Numeric variables not used in analysis (i.e. ARMN)
Null variables (i.e. AVISIT/AVISITN)
Variables from ADSL can be copied to other ADaM datasets without renaming to a new variable (i.e. AX01SDT in BDS = ADSL.TR01SDT)
Variables coming from SDTM should be copied without changes, but bad SDTM should not necessarily translate to bad ADaM (i.e. TPT containing VISIT)

6. General #2 Date/time variables
Respect suffix conventions (DT, TM, DTM, DTF, TMF, DY)
Date/time variables should have associated study day variables.
When date/time imputation are needed it is a good idea to keep the SDTM variable that contains the partial value
Creating the DT, TM, and DTM triplicate just because it can be done is not necessary
For a given SDTM DTC variable, if only hh and mm are collected, and ss are imputed in *DTM as 00, then it is not necessary to set *TMF to “S”. However if collected but are missing should be qualified in *TMF.

7. General #2 (example) Date/time Example 1 Date/time Example 2 SDTM ADAM
--DTC
T12:00
T10:30
--DT
--TM
--DY
12:00:00 1
10:30:00 16
--DTC
T12:00
T10:31:50
--DT
--TM
--TMF
--DY
12:00:00 S 1
10:31:50 16

8. General #3 Visit/Time Point Variables
AVISIT/AVISITN/ATPT/ATPN should be the timing variables that are in datasets –VISIT/VISITNUM/--TPT/--TPTNUM should also be kept if the values/algorithms differ
VISIT/VISITNUM have to come from SDTM and cannot be derived/changed in ADaM but bad SDTM should not necessarily translate to bad ADaM (TPT containing VISIT values)
AVISIT –last value within a window is not an ENDPOINT value unless you are outputting an extra record –if true then DTYPE has to be present. If not then ANLzzFLshould be used
AVISIT –RESCREEN/UNSCHEDULED are not generally valid AVISIT values unless they are summarized on the table or defined in the SAP –if not they should be null (or windowed)

9. General #3 (example) Visit/time point bad implementation
Visit/time point good implementation
uses XXSTRESU value
AVISIT
ATPT
PARAM
Day 1 – 12 h
Heart rate (bpm) – Day 1 – 12 h
Baseline
DIASTOLIC BLOOD PRESSURE
AVISIT
ATPT
PARAM
Day 1
12 h
Heart rate (bpm)
Baseline
Diastolic Blood Pressure (mmHg)*

10. ADSL #1 Population Flags
ITTFL do not created it, if is same as RANDFL and not defined in protocol/SAP
RANDFL – why is it tied to being dosed?
DISCFL this appears to be the inverse of COMPLFL (only one)
NOMEDFL what is the purpose of a combination flag? (use the available flags)
Some population flags in the efficacy analysis are too complicated. Can we generate these population flags by referring to each other? Circular logic is always a concern

11. ADSL #2 Treatment Variables ARM/ARMCD are not analysis variables
do not have to be included in every dataset – Use (TRTSEQP)
There is no variable ARMGR1 in ADaM
ARMN is not necessary
ARM is required per the ADaMIG v1.1 for traceability, ACTARM is perm
TRT01A –do you check whether Actual differs from Planned or do you always create?
Check order TRT01P vs TRT02P (TR01SDT/TR01EDT vs TR02SDT/TR02EDT). Check also TRTSEQP (order is reversed?)

12. ADSL #3 Treatment duration
Duration AEXDURN –I don’t see why this is prefixed with A/Analysis –EXDURN is sufficient
xxxDUR– DUR in SDTM is ISO8601. Use ADaMIG v1.1 defined variables and xxxDURC (if needed)
ADSL –do you have any subjects with missing disposition records? it should be null in that case and not “discontinued” –make sure metadata covers all scenarios

13. ADSL #4
Date Variables
APxxSDT/APxxEDT are paired variables –both or neither should be present
There should not be more APxx variables then there are TRTxxP
ADSL.TRTSDT/TRTEDT –required ADSL.TR01SDT/TR01EDT –not needed in a single period trial
TRTSDT/TRTEDT based on RFX not RF (start of trt not the study)
LSTVST (based on Last SV record in spec)? SV has no “order” unless VISITNUM is in the correct order VISITNUM (i.e. 99 for Unscheduled)
Is there a reason you format dates as DATE9 instead of YYMMDD10? No right or wrong but you should be consistent across datasets

14. ADSL #5
Other Variables
SEX per SDTM is M/F –you cannot change any SDTM variable value in ADaM
DEATHFL –why not use SDTM variable DTHFL?
DSTERM/DSDECOD may be one of several DS records –renaming to useful concept is helpful
HEIGHT should be HEIGHTBL or BLHEIGHT to indicate it is a baseline value (similar to label)
Baseline variables should start or end with BL and not just B
AGEU is required

15. BDS #1
Population flags
all BDS have to have at least one population flag variable –however not all ADSL population variables have to included in every ADaM dataset
Can we add free text to the label of ANLzzFL or any variable with y, zz, xx? e.g: added text “Analysis Flag zz–Last for Dup. Records” Yes for y and zz but not for xx
ADxx-xxxxxFL–values of 1-4 are not allowed for an FL variable
ADLB -no ANLzzFL variables are needed for analysis? (this is possible if there are no multiple nominal visit values and unscheduled values are not summarized)
Is –BLFL=Y always the value where ABLFL=Y?

16. BDS #2 Incorrect/Iffy Variables/Values
AVALU is not a valid ADaM variable –if unit is relevant it should be included in PARAM if not then just keep ORRESU/STRESU
ADxx-AVALC is not left-justified for numeric values (nor does AVALC have to be populated for numeric parameters)
ADDV -AVALC – are these values actually analyzed/summarized? Is there a protocol deviation summary –why was this ADaM created? Shouldn’t ADDV be OCCDS in any case?
ADPE -Summary is by AVISIT –why are ABLFL/BASEC needed?

17. BDS #3 PARAM/PARAMCD/LBCAT
ADLB -LBTEST/LBTESTCD generally are not sufficient for PARAM/PARAMCD in labs since there are the same –TEST in CHEMISTRY and URINALYSISPARAM/PARAMCD have to uniquely identify -using PARCAT1 is not allowed –GLUC cannot have two different PARCAT1 values
Is it your standard or the sponsor’s standard to capture LBCAT in PARAM instead of only the ones that are common in more than one LBCAT? Any value added in capturing on all PARAMCD? Only add U to the ones that are in more than one LBCAT can be enough

18. BDS #3 (Example) PARAM/PARAMCD/LBCAT Wrong definition
Correct definition
PARAMCD
PARAM
PARCAT1 CA
Urine Calcium
URINALYSIS
Blood Calcium
CHEMISTRY
RBC
Blood Erythrocytes
HAEMATOLOGY
CAU
Urine Calcium
URINALYSIS CA
Calcium
CHEMISTRY
RBC
Erythrocytes
HAEMATOLOGY

19. BDS #4 Incorrect/Iffy Variables/Values (continue)
ADLB -A lot of the PARAM appear to be CRIT values and should not be added parameters (e.gALKGR15) -for the ones that look at multiple PARAM it makes sense but not so much for the ones that are within PARAM

20. BDS #4 (Example) PARAM/PARAMCD/LBCAT Bad definition Good definition
AVAL
AVALC
ALK 20
ALKGR15 Y
PARAMCD
AVAL
CRIT1
CRIT1FL
ALK 20
ALK > 15 Y

21. BDS #5 BASE/BASETYPE AVALCATy/CRITy
ADLB -BASETYPE is not populated for all records within a PARAM
ADLB/ADVS -Having BASE and not CHG seems odd –what is the purpose?
BASE should reference ABLFL and not AVISITN ADaMIG -BASE contains the value of AVAL copied from a record within the parameter on which ABLFL = “Y” (and BNRIND=ANRIND where ABLFL=‘Y’)
AVALCATy/CRITy
ADxx.AVALCAT1/AVALCAT2 -these can only be categorizations of AVAL –only CRITy/MCRITy can be based on “any” variable
CRITy has to be a constant value within PARAM – if it varies then use AVALCATy (or MCRITyML)

22. BDS #5 (Example) AVALCATy/CRITy Bad definition Good definition AVAL
CHG
AVALCAT1* 90
High 20
GT 90 and CHG > 20 95 10
AVAL
AVALC
CHG
AVALCAT1
CRIT1*
CRIT1FL* 90 20
High
GT 90 and CHG > 20 Y 95 10

23. BDS #6
Timing Variables
ENDPOINT BASELINE is not a correct AVISIT value –this should be AVISIT=BASELINE with DTYPE=AVERAGE.
Why are there AVISIT=ENDPOINT xxxx in any case –it does not have that on the tables
What does ATPT=ENDPOINT 0.5 H POST-DOSE mean? If these are supposed to identify the average value then DBTYPE should be used and not a changed ATPT value –it is not a different visit/timepoint
ADTC – often included this. Value added?

24. BDS #7
DTYPE
DTYPE=SUM or COMBINED is incorrect –DTYPE is for records within a parameter and not totally derived parameters
DTYPE=MAXIMUM (used to identify a maximum record) -this is incorrect usage of DTYPE -there is no indication that there is an added row with AVISIT="Maximum" -this should be identified with an ANLzzFL
DTYPE=EOT is not correct –it does not describe the derivation method (it could be LOV Last Observed Value)
ADLB -LBMAXFL/LBMINFL/POSTHIFL/POSTLOFL (and all the rest of the flags) –these should all be ANLzzFL (or AVISIT added rows) –see section of the ADaMIG

25. BDS #7 (Example) Wrong Use ANLxxFL Add AVISIT and Use DBTYPE AVISIT
PARAMCD
AVAL
DBTYPE
Week 1
DBP 80
Week 2
120
MAXIMUM
POSTHIFL Y
AVISIT
PARAMCD
AVAL
ANL01FL
Week 1
DBP 80
Week 2
120 Y
AVISIT
PARAMCD
AVAL
DBTYPE
Week 1
DBP 80
Week 2
120
Post-Baseline Maximum
MAXIMUM

26. OCCDS #1
ADAE
ADAE -Creating records with ANYAE=N and populating AETERM with None for subjects with no AEs is not allowed
AEDUR is an SDTM variable that is character and ISO 8601 –it cannot be changed to numeric in ADaM. Use ADURN (derived)
Do not change SDTM variables as AEOUTR (SDTM.AE.AEOUT), AESEV should be SDTM.AESEV
TRTEMFL -derivation may not be correct if time is imputed –use caution in defining TRTEMFL
ASTDT should be included even if ASTDTM is present. No a requirement –just a suggestion

27. OCCDS #2
ADCM /ADMH
ADCM -CMDOSU/CMDOSFRQ/CMROUTE changed from SDTM values –this is not allowed
ADMH –ASTDT/AENDT –do these add value? These appear to be mostly partial dates

28. Conclusion
Thanks for your attention
Questions?