Typical workflow for ADaM database generation and validation

1. Review protocol, SAP, and CRF

2. Develop internal SDTM and ADaM specifications

3. Create initial metadata based on specifications

4. Build SDTM datasets

5. Validate SDTM datasets using Pinnacle 21

6. Update SDTM datasets and metadata to resolve validation issues

7. Build ADaM datasets based on SDTM and SAP

8. Validate ADaM datasets using Pinnacle 21

9. Update ADaM datasets and metadata to resolve validation issues

10. Generate define.xml from finalized metadata

11. Run Pinnacle 21 validation on datasets and define.xml

12. Review and resolve remaining validation issues

13. Update metadata / define.xml as needed

14. Repeat steps 10–13 until acceptable validation status is achieved

15. Freeze SDTM, ADaM datasets, metadata, and define.xml

DM specification

Variable Name	Variable Label	Variable Type	Variable Length	Variable Origin	CRF Page	Code List	User Notes
STUDYID	Study Identifier	Character	25	Protocol			Set to'XYZ-0102'
DOMAIN	Domain Abbreviation	Character	2	Assigned		DOMAIN	Set to 'DM'
USUBJID	Unique Subject Identifier	Character	20	Derived			Concatenate the STUDYID and SUBJECT separated by '-'
SUBJID	Subject Identifier for the Study	Character	9	CRF Page	31		RAW.RANDOM.SUBJECT
RFSTDTC	Subject Reference Start Date/Time	Character	19	Derived			The first datetime of the subject in EXTO EXTO.EXSTDAT||EXSTTIM
RFENDTC	Subject Reference End Date/Time	Character	10	Derived			The last datetime of the subject in EXTO EXTO.EXSTDAT||EXSTTIM
DTHDTC	Date/Time of Death	Character	19	CRF Page	16		RAW.DTH.DTHDAT
DTHFL	Subject Death Flag	Character	1	CRF Page	16	NY	Set to 'Y' if RAW.DS.DSDECOD='Death' or DTH.DTHDAT or DTH.DTHORRES is not missing
SITEID	Study Site Identifier	Character	6	Assigned			DMMO.SITENUMBER
BRTHDTC	Date/Time of Birth	Character	10	CRF Page	31		DMMO.BRTHDAT
AGE	Age	Numeric	8	CRF			if AGE available in DMMO, then use AGE else calculate as int((RFSTDTC-BRTHDTC)/365.25)
AGEU	Age Units	Character	25	Assigned		AGEU	Set to 'YEARS'
SEX	Sex	Character	1	CRF Page	31	SEX	RAW.DMMO.SEX
RACE	Race	Character	50	CRF Page	31	RACE	RAW.DMMO: if ASIAN=1 then RACE='ASIAN'; if BLACK=1 then RACE='BLACK OR AFRICAN AMERICAN '; if AMERICAN_INDIAN=1 then RACE='AMERICAN INDIAN OR ALASKA NATIVE '; if WHITE=1 then RACE='WHITE '; if NATIVE_HAWAIIAN=1 then RACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER '; If more than one race selected then RACE='MULTIPLE';
ETHNIC	Ethnicity	Character	30	CRF Page	31	ETHNIC	RAW.DMMO.ETHNIC
ARMCD	Planned Arm Code	Character	20	Assigned			Use dataset RAW.RAND_SUBJ: Where RANDYN='Yes', assign A or B randomly to subjects; Assign "SCRNFAIL" to screen failures; For subjects who are not 'SCRNFAIL' and not randomized, set it to 'NOTASSGN'
ARM	Description of Planned Arm	Character	200	Protocol			if ARMCD=A then ARM="APTX 1 mL" if ARMCD=B then ARM="Placebo 1 mL" If ARMCD='SCRNFAIL' then ARM='Screen Failure' If ARMCD='NOTASSGN' then ARM='Not Assigned'
ACTARMCD	Actual Arm Code	Character	20	Assigned			Use dataset RAW.RAND_SUBJ: Where RANDYN='Yes', assign A or B randomly to subjects; Assign "SCRNFAIL" to screen failures; For subjects who are not 'SCRNFAIL' and not randomized, set it to 'NOTASSGN'
ACTARM	Description of Actual Arm	Character	200	Assigned			if ARMCD=A then ARM="APTX 1 mL" if ARMCD=B then ARM="Placebo 1 mL" If ARMCD='SCRNFAIL' then ARM='Screen Failure' If ARMCD='NOTASSGN' then ARM='Not Assigned'
COUNTRY	Country	Character	3	Assigned		COUNTRY	USA- if SITE ID between 1000-1099 MEX- if SITE ID between 3000-3099 PER- if SITE ID between 4000-4099 ARG- if SITE ID between 5000-5099 CHL- if SITE ID between 7000-7099

https://www.mycsg.in/sdtm.php?area=SDTM&concept=AE&lesson=SDTM_AE_LCSG001#SPEC