Examples SDTM.EC

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECLNKID	ECTRT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRQ	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY
IG33_EC_EC_001	ABC	EC	ABC1001	1	A2-20110114	BOTTLE A	Y	Y	2	TABLET	QD	TREATMENT	2011-01-14	2011-01-28	1	15
IG33_EC_EC_001	ABC	EC	ABC2001	1	A2-20110114	BOTTLE A	Y	Y	2	TABLET	QD	TREATMENT	2011-01-14	2011-01-23	1	10
IG33_EC_EC_001	ABC	EC	ABC2001	2	A0-20110124	BOTTLE A	Y	N		TABLET	QD	TREATMENT	2011-01-24	2011-01-24	11	11
IG33_EC_EC_001	ABC	EC	ABC2001	3	A2-20110125	BOTTLE A	Y	Y	2	TABLET	QD	TREATMENT	2011-01-25	2011-01-28	12	15

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECSPID	ECLNKID	ECTRT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRM	ECDOSFRQ	ECROUTE	ECLOC	ECLAT	VISITNUM	VISIT	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY
IG33_EC_EC_002	ABC	EC	ABC3001	1	INJ1	V3	DRUG X	Y	Y	5	mL	INJECTION	ONCE	SUBCUTANEOUS	ABDOMEN	LEFT	3	VISIT 3	TREATMENT	2009-05-10	2009-05-10	21	21
IG33_EC_EC_002	ABC	EC	ABC3001	2	INJ2	V3	DRUG X	Y	Y	5	mL	INJECTION	ONCE	SUBCUTANEOUS	ABDOMEN	CENTER	3	VISIT 3	TREATMENT	2009-05-10	2009-05-10	21	21
IG33_EC_EC_002	ABC	EC	ABC3001	3	INJ3	V3	DRUG X	Y	Y	5	mL	INJECTION	ONCE	SUBCUTANEOUS	ABDOMEN	RIGHT	3	VISIT 3	TREATMENT	2009-05-10	2009-05-10	21	21

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECTRT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRQ	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY
IG33_EC_EC_003	ABC	EC	ABC4001	1	BOTTLE A	Y	Y	1	TABLET	QD	TREATMENT	2011-01-14	2011-01-28	1	15
IG33_EC_EC_003	ABC	EC	ABC4001	2	BOTTLE C	Y	Y	1	TABLET	QD	TREATMENT	2011-01-14	2011-01-28	1	15
IG33_EC_EC_003	ABC	EC	ABC4001	3	BOTTLE B	Y	Y	1	TABLET	QD	TREATMENT	2011-01-14	2011-01-20	1	7
IG33_EC_EC_003	ABC	EC	ABC4001	4	BOTTLE B	Y	N		TABLET	QD	TREATMENT	2011-01-21	2011-01-21	8	8
IG33_EC_EC_003	ABC	EC	ABC4001	5	BOTTLE B	Y	Y	2	TABLET	QD	TREATMENT	2011-01-22	2011-01-22	9	9
IG33_EC_EC_003	ABC	EC	ABC4001	6	BOTTLE B	Y	Y	1	TABLET	QD	TREATMENT	2011-01-23	2011-01-28	10	15

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECLNKID	ECTRT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRQ	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY	ECTPT	ECTPTNUM
IG33_EC_EC_005	ABC	EC	ABC5001	1	20120101-20120108-AM	BOTTLE A	Y	Y	1	TABLET	QD	TREATMENT	2012-01-01	2012-01-08	1	8	AM	1
IG33_EC_EC_005	ABC	EC	ABC5001	2	20120101-20120108-PM	BOTTLE B	Y	Y	1	TABLET	QD	TREATMENT	2012-01-01	2012-01-08	1	8	PM	2
IG33_EC_EC_005	ABC	EC	ABC5002	1	20120201-20120208-AM	BOTTLE A	Y	Y	1	TABLET	QD	TREATMENT	2012-02-01	2012-02-08	1	8	AM	1
IG33_EC_EC_005	ABC	EC	ABC5002	2	20120201-20120208-PM	BOTTLE B	Y	Y	1	TABLET	QD	TREATMENT	2012-02-01	2012-02-08	1	8	PM	2
IG33_EC_EC_005	ABC	EC	ABC5003	1	20120301-20120308-AM	BOTTLE A	Y	Y	1	TABLET	QD	TREATMENT	2012-03-01	2012-03-08	1	8	AM	1
IG33_EC_EC_005	ABC	EC	ABC5003	2	20120301-20120308-PM	BOTTLE B	Y	Y	1	TABLET	QD	TREATMENT	2012-03-01	2012-03-08	1	8	PM	2

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECTRT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRM	ECDOSFRQ	ECROUTE	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY	ECTPT	ECELTM	ECTPTREF
IG33_EC_EC_006	56789	EC	56789001	1	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-01T07:30	2002-07-01T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	2	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-01T07:30	2002-07-01T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	3	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-02T07:30	2002-07-02T07:30	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	4	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-02T07:30	2002-07-02T07:30	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	5	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-03T07:32	2002-07-03T07:32	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	6	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-03T07:32	2002-07-03T07:32	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	7	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-09T07:30	2002-07-09T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	8	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-09T07:30	2002-07-09T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	9	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-10T07:30	2002-07-10T07:30	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	10	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-10T07:30	2002-07-10T07:30	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	11	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-11T07:34	2002-07-11T07:34	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789001	12	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-11T07:34	2002-07-11T07:34	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	1	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-03T07:30	2002-07-03T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	2	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-03T07:30	2002-07-03T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	3	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-04T07:24	2002-07-04T07:24	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	4	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-04T07:24	2002-07-04T07:24	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	5	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-05T07:24	2002-07-05T07:24	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	6	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-05T07:24	2002-07-05T07:24	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	7	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-11T07:30	2002-07-11T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	8	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-11T07:30	2002-07-11T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	9	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-12T07:43	2002-07-12T07:43	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	10	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-12T07:43	2002-07-12T07:43	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	11	BOTTLE 1	Y	Y	1	CAPSULE	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-13T07:38	2002-07-13T07:38	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EC_006	56789	EC	56789003	12	BOTTLE 2	Y	Y	1	TABLET, COATED	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-13T07:38	2002-07-13T07:38	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECLNKID	ECLNKGRP	ECTRT	ECMOOD	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECPSTRG	ECPSTRGU	ECADJ	VISITNUM	VISIT	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY
IG33_EC_EC_007	ABC123	EC	ABC123-0201	1		V1	DRUG Z	SCHEDULED			10	mg/kg				1	VISIT 1	TREATMENT	2009-02-13	2009-02-13	1	1
IG33_EC_EC_007	ABC123	EC	ABC123-0201	2	20090213 T1000	V1	DRUG Z	PERFORMED	Y	Y	99	mL	5.5	mg/mL		1	VISIT 1	TREATMENT	2009-02-13T10:00	2009-02-13T10:45	1	1
IG33_EC_EC_007	ABC123	EC	ABC123-0201	3		V2	DRUG Z	SCHEDULED			7.5	mg/kg			Dose limiting toxicity	2	VISIT 2	TREATMENT	2009-02-20	2009-02-20	8	8
IG33_EC_EC_007	ABC123	EC	ABC123-0201	4	20090220 T1100	V2	DRUG Z	PERFORMED	Y	Y	35	mL	4.12	mg/mL		2	VISIT 2	TREATMENT	2009-02-20T11:00	2009-02-20T11:20	8	8
IG33_EC_EC_007	ABC123	EC	ABC123-0201	5		V3	DRUG Z	SCHEDULED			7.5	mg/kg				3	VISIT 3	TREATMENT	2009-02-27	2009-02-27	15	15
IG33_EC_EC_007	ABC123	EC	ABC123-0201	6	20090227	V3	DRUG Z	PERFORMED	Y	N		mL	4.12	mg/mL		3	VISIT 3	TREATMENT	2009-02-27	2009-02-27	15	15

Example	STUDYID	DOMAIN	USUBJID	ECSEQ	ECTRT	ECCAT	ECPRESP	ECOCCUR	ECDOSE	ECDOSU	ECDOSFRQ	EPOCH	ECSTDTC	ECENDTC	ECSTDY	ECENDY
IG33_EC_EC_008	ABC	EC	ABC7001	1	BOTTLE A	FIRST TO LAST DOSE INTERVAL	Y	Y	1	TABLET	QD	TREATMENT	2012-01-13	2012-01-20	1	8
IG33_EC_EC_008	ABC	EC	ABC7001	2	BOTTLE A	EXCEPTION DOSE	Y	N		TABLET	QD	TREATMENT	2012-01-15	2012-01-15	3	3
IG33_EC_EC_008	ABC	EC	ABC7001	3	BOTTLE A	EXCEPTION DOSE	Y	Y	2	TABLET	QD	TREATMENT	2012-01-16	2012-01-16	4	4

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXLNKID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
IG33_EC_EX_001	ABC	EX	ABC1001	1	A2-20110114	DRUG X	1000	mg	TABLET, EXTENDED RELEASE	QD	ORAL	TREATMENT	2011-01-14	2011-01-28	1	15
IG33_EC_EX_001	ABC	EX	ABC2001	1	A2-20110114	DRUG Z	500	mg	TABLET	QD	ORAL	TREATMENT	2011-01-14	2011-01-23	1	10
IG33_EC_EX_001	ABC	EX	ABC2001	2	A2-20110125	DRUG Z	500	mg	TABLET	QD	ORAL	TREATMENT	2011-01-25	2011-01-28	12	15

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXSPID	EXLNKID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EXLOC	VISITNUM	VISIT	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
IG33_EC_EX_002	ABC	EX	ABC3001	1		V3	DRUG X	3	mg/kg	INJECTION	ONCE	SUBCUTANEOUS	ABDOMEN	3	VISIT 3	TREATMENT	2009-05-10	2009-05-10	21	21

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
IG33_EC_EX_003	ABC	EX	ABC4001	1	DRUG X	20	mg	TABLET	QD	ORAL	TREATMENT	2011-01-14	2011-01-20	1	7
IG33_EC_EX_003	ABC	EX	ABC4001	2	DRUG X	10	mg	TABLET	QD	ORAL	TREATMENT	2011-01-21	2011-01-21	8	8
IG33_EC_EX_003	ABC	EX	ABC4001	3	DRUG X	30	mg	TABLET	QD	ORAL	TREATMENT	2011-01-22	2011-01-22	9	9
IG33_EC_EX_003	ABC	EX	ABC4001	4	DRUG X	20	mg	TABLET	QD	ORAL	TREATMENT	2011-01-23	2011-01-28	10	15

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXLNKID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY	EXTPT	EXTPTNUM
IG33_EC_EX_005	ABC	EX	ABC5001	1	20120101-20120108-AM	DRUG X	10	mg	TABLET	QD	ORAL	TREATMENT	2012-01-01	2012-01-08	1	8	AM	1
IG33_EC_EX_005	ABC	EX	ABC5001	2	20120101-20120108-PM	DRUG X	10	mg	TABLET	QD	ORAL	TREATMENT	2012-01-01	2012-01-08	1	8	PM	2
IG33_EC_EX_005	ABC	EX	ABC5002	1	20120201-20120208-AM	DRUG X	10	mg	TABLET	QD	ORAL	TREATMENT	2012-02-01	2012-02-08	1	8	AM	1
IG33_EC_EX_005	ABC	EX	ABC5002	2	20120201-20120208-PM	PLACEBO	0	mg	TABLET	QD	ORAL	TREATMENT	2012-02-01	2012-02-08	1	8	PM	2
IG33_EC_EX_005	ABC	EX	ABC5003	1	20120301-20120308-AM	PLACEBO	0	mg	TABLET	QD	ORAL	TREATMENT	2012-03-01	2012-03-08	1	8	AM	1
IG33_EC_EX_005	ABC	EX	ABC5003	2	20120301-20120308-PM	PLACEBO	0	mg	TABLET	QD	ORAL	TREATMENT	2012-03-01	2012-03-08	1	8	PM	2

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EPOCH	EXSTDTC	EXSTDY	EXENDY	EXTPT	EXELTM	EXTPTREF
IG33_EC_EX_006	56789	EX	56789001	1	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-01T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	2	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-01T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	3	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-02T07:30	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	4	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-02T07:30	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	5	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-03T07:32	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	6	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-03T07:32	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	7	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-09T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	8	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-09T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	9	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-10T07:30	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	10	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-10T07:30	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	11	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-11T07:34	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789001	12	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-11T07:34	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	1	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-03T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	2	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-03T07:30	1	1	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	3	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-04T07:24	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	4	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-04T07:24	2	2	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	5	PLACEBO	0	mg	CAPSULE	QD	ORAL	TREATMENT 1	2002-07-05T07:24	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	6	DRUG B	30	mg	TABLET, COATED	QD	ORAL	TREATMENT 1	2002-07-05T07:24	3	3	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	7	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-11T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	8	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-11T07:30	9	9	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	9	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-12T07:43	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	10	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-12T07:43	10	10	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	11	DRUG A	20	mg	CAPSULE	QD	ORAL	TREATMENT 2	2002-07-13T07:38	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST
IG33_EC_EX_006	56789	EX	56789003	12	PLACEBO	0	mg	TABLET, COATED	QD	ORAL	TREATMENT 2	2002-07-13T07:38	11	11	30 MINUTES PRIOR	-PT30M	STD BREAKFAST

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXLNKID	EXLNKGRP	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EXADJ	VISITNUM	VISIT	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
IG33_EC_EX_007	ABC123	EX	ABC123-0201	1	20090213T1000	V1	DRUG Z	9.9	mg/kg	SOLUTION	CONTINUOUS	INTRAVENOUS		1	VISIT 1	TREATMENT	2009-02-13T10:00	2009-02-13T10:00	1	1
IG33_EC_EX_007	ABC123	EX	ABC123-0201	2	20090220T1100	V2	DRUG Z	2.6	mg/kg	SOLUTION	CONTINUOUS	INTRAVENOUS	Injection site reaction	2	VISIT 2	TREATMENT	2009-02-20T11:00	2009-02-20T11:00	8	8

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
IG33_EC_EX_008	ABC	EX	ABC7001	1	DRUG X	100	mg	TABLET	QD	ORAL	TREATMENT	2012-01-13	2012-01-14	1	2
IG33_EC_EX_008	ABC	EX	ABC7001	2	DRUG X	200	mg	TABLET	QD	ORAL	TREATMENT	2012-01-16	2012-01-16	4	4
IG33_EC_EX_008	ABC	EX	ABC7001	3	DRUG X	100	mg	TABLET	QD	ORAL	TREATMENT	2012-01-17	2012-01-20	5	8

Example	STUDYID	DOMAIN	USUBJID	FASEQ	FALNKID	FATESTCD	FATEST	FAOBJ	FAORRES	FAORRESU	FASTRESC	FASTRESN	FASTRESU	VISITNUM	VISIT	EPOCH
IG33_EC_FA_007	ABC123	FA	ABC123-0201	1	20090213T1000	DOSEALT	Dose in Alternative Unit	DRUG Z	522.5	mg	522.5	522.5	mg	1	VISIT 1	TREATMENT
IG33_EC_FA_007	ABC123	FA	ABC123-0201	2	20090220T1100	DOSEALT	Dose in Alternative Unit	DRUG Z	144.2	mg	144.2	144.2	mg	2	VISIT 2	TREATMENT

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
IG33_EC_RELREC_001	ABC	EC		ECLNKID		ONE	1
IG33_EC_RELREC_001	ABC	EX		EXLNKID		ONE	1

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
IG33_EC_RELREC_002	ABC	EC		ECLNKID		MANY	1
IG33_EC_RELREC_002	ABC	EX		EXLNKID		ONE	1

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
IG33_EC_RELREC_005	ABC	EC		ECLNKID		ONE	1
IG33_EC_RELREC_005	ABC	EX		EXLNKID		ONE	1

Example	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
IG33_EC_RELREC_007	ABC123	EC	ECLNKID	ONE	1
IG33_EC_RELREC_007	ABC123	EX	EXLNKID	ONE	1
IG33_EC_RELREC_007	ABC123	EC	ECLNKGRP	MANY	2
IG33_EC_RELREC_007	ABC123	EX	EXLNKGRP	ONE	2
IG33_EC_RELREC_007	ABC123	EX	EXLNKID	ONE	3
IG33_EC_RELREC_007	ABC123	FA	FALNKID	ONE	3

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
IG33_EC_SUPPEC_001	ABC	EC	ABC2001	ECSEQ	2	ECREASOC	Reason for Occur Value	PATIENT MISTAKE	CRF

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
IG33_EC_SUPPEC_007	ABC	EC	ABC123-0201	ECSEQ	6	ECREASOC	Reason for Occur Value	PERSONAL REASON	CRF