mycsg.in
  • SAS
  • SASnR
  • Clinical Programming
    CRFs SDTM ADaM TFL Tasks Macros
  • QnA
  • Certification
  • Resources
  • Disclaimer
  • Contact Us
  • Training
  • Sign Up
  • Login
IG33_DS_AE_004 IG33_DS_DM_010 IG33_DS_DS_001 IG33_DS_DS_002 IG33_DS_DS_003 IG33_DS_DS_004 IG33_DS_DS_005 IG33_DS_DS_006 IG33_DS_DS_007 IG33_DS_DS_008 IG33_DS_DS_009 IG33_DS_DS_010 IG33_DS_DS_011 IG33_DS_EX_010 IG33_DS_RELREC_004 IG33_DS_SE_010 IG33_DS_SE_011 IG33_DS_TA_010 IG33_DS_TA_011 IG33_DS_TE_010 IG33_DS_TE_011
Example STUDYID DOMAIN USUBJID AESEQ AETERM AESTDTC AEENDTC AEDECOD AESOC AESEV AESER AEACN AEREL AEOUT AESCAN AESCONG AESDISAB AESDTH AESHOSP AESLIFE AESOD AESMIE
IG33_DS_AE_004 ABC123 AE 123102 1 Heart Failure 2003-09-29 2003-09-29 HEART FAILURE CARDIOVASCULAR SYSTEM SEVERE Y NOT APPLICABLE DEFINITELY NOT RELATED FATAL N N N Y N N N N
Example STUDYID DOMAIN USUBJID SUBJID RFXSTDTC RFXENDTC RFICDTC RFPENDTC SITEID INVNAM ARMCD ARM ACTARMCD ACTARM ARMNRS ACTARMUD
IG33_DS_DM_010 XYZ DM XYZ-767-001 001 2016-02-14 2016-04-19 2016-02-02 2016-04-24 01 ADAMS, M DG1INDG Drug-1+Investigation-Drug DG1INDG Drug-1+Investigation-Drug
IG33_DS_DM_010 XYZ DM XYZ-767-002 002 2016-02-21 2016-04-24 2016-02-04 2016-04-29 01 ADAMS, M DG2INDG Drug-2+Investigation-Drug DG2INDG Drug-2+Investigation-Drug
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT EPOCH DSDTC DSSTDTC
IG33_DS_DS_001 ABC123 DS 123101 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2003-09-21 2003-09-21
IG33_DS_DS_001 ABC123 DS 123101 2 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE SCREENING 2003-09-30 2003-09-30
IG33_DS_DS_001 ABC123 DS 123101 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION SCREENING 2003-09-30 2003-09-29
IG33_DS_DS_001 ABC123 DS 123101 4 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION TREATMENT 2003-10-31 2003-10-31
IG33_DS_DS_001 ABC123 DS 123101 5 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION FOLLOW-UP 2003-11-15 2003-11-15
IG33_DS_DS_001 ABC123 DS 123102 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2003-11-21 2003-11-21
IG33_DS_DS_001 ABC123 DS 123102 2 SUBJECT DENIED MRI PROCEDURE PROTOCOL VIOLATION DISPOSITION EVENT STUDY PARTICIPATION SCREENING 2003-11-22 2003-11-20
IG33_DS_DS_001 ABC123 DS 123103 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2003-09-15 2003-09-15
IG33_DS_DS_001 ABC123 DS 123103 2 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE SCREENING 2003-09-30 2003-09-30
IG33_DS_DS_001 ABC123 DS 123103 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION SCREENING 2003-09-30 2003-09-22
IG33_DS_DS_001 ABC123 DS 123103 4 SUBJECT MOVED LOST TO FOLLOW-UP DISPOSITION EVENT STUDY PARTICIPATION TREATMENT 2003-10-31 2003-10-31
IG33_DS_DS_001 ABC123 DS 123104 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2003-09-15 2003-09-15
IG33_DS_DS_001 ABC123 DS 123104 3 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE SCREENING 2003-09-30 2003-09-30
IG33_DS_DS_001 ABC123 DS 123104 2 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION SCREENING 2003-09-30 2003-09-22
IG33_DS_DS_001 ABC123 DS 123104 4 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION TREATMENT 2003-10-15 2003-10-15
IG33_DS_DS_001 ABC123 DS 123104 5 AUTOMOBILE ACCIDENT DEATH DISPOSITION EVENT STUDY PARTICIPATION FOLLOW-UP 2003-10-31 2003-10-29
IG33_DS_DS_001 ABC123 DS 123105 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2003-09-28 2003-09-28
IG33_DS_DS_001 ABC123 DS 123105 2 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE SCREENING 2003-10-02 2003-10-02
IG33_DS_DS_001 ABC123 DS 123105 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION SCREENING 2003-10-02 2003-10-02
IG33_DS_DS_001 ABC123 DS 123105 4 ANEMIA ADVERSE EVENT DISPOSITION EVENT STUDY PARTICIPATION TREATMENT 2003-10-17 2003-10-17
IG33_DS_DS_001 ABC123 DS 123105 5 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION FOLLOW-UP 2003-11-02 2003-11-02
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT EPOCH DSSTDTC
IG33_DS_DS_002 ABC456 DS 456101 1 COMPLETED COMPLETED DISPOSITION EVENT FOLLOW-UP 2003-09-21
IG33_DS_DS_002 ABC456 DS 456102 1 SUBJECT TAKING STUDY MED ERRATICALLY PROTOCOL VIOLATION DISPOSITION EVENT TREATMENT 2003-09-29
IG33_DS_DS_002 ABC456 DS 456103 1 LOST TO FOLLOW-UP LOST TO FOLLOW-UP DISPOSITION EVENT TREATMENT 2003-10-15
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT EPOCH DSSTDTC
IG33_DS_DS_003 ABC789 DS 789101 1 COMPLETED COMPLETED DISPOSITION EVENT TREATMENT 2004-09-12
IG33_DS_DS_003 ABC789 DS 789101 2 COMPLETED COMPLETED DISPOSITION EVENT FOLLOW-UP 2004-12-20
IG33_DS_DS_003 ABC789 DS 789102 1 SKIN RASH ADVERSE EVENT DISPOSITION EVENT TREATMENT 2004-09-30
IG33_DS_DS_003 ABC789 DS 789102 2 SUBJECT HAD SEVERE RASH TREATMENT UNBLINDED OTHER EVENT TREATMENT 2004-10-01
IG33_DS_DS_003 ABC789 DS 789102 3 COMPLETED COMPLETED DISPOSITION EVENT FOLLOW-UP 2004-12-28
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT EPOCH DSDTC DSSTDTC
IG33_DS_DS_004 ABC123 DS 123102 1 Heart Failure DEATH DISPOSITION EVENT TREATMENT 2003-09-29 2003-09-29
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC EPOCH
IG33_DS_DS_005 XXX DS XXX-767-001 1 PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED PHYSICIAN DECISION DISPOSITION EVENT LEVOFLOXACIN 2016-02-15 TREATMENT 1
IG33_DS_DS_005 XXX DS XXX-767-001 2 COMPLETED COMPLETED DISPOSITION EVENT ISONIAZID 2016-02-15 TREATMENT 1
IG33_DS_DS_005 XXX DS XXX-767-001 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-02-25 TREATMENT 1
IG33_DS_DS_005 XXX DS XXX-767-001 4 COMPLETED COMPLETED DISPOSITION EVENT ISONIAZID 2016-03-14 TREATMENT 2
IG33_DS_DS_005 XXX DS XXX-767-001 5 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-03-24 TREATMENT 2
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC EPOCH
IG33_DS_DS_006 XXX DS XXX-767-001 1 PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED PHYSICIAN DECISION DISPOSITION EVENT LEVOFLOXACIN 2016-02-15 TREATMENT 1
IG33_DS_DS_006 XXX DS XXX-767-001 2 COMPLETED COMPLETED DISPOSITION EVENT ISONIAZID 2016-03-14 TREATMENT 2
IG33_DS_DS_006 XXX DS XXX-767-001 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-03-24 TREATMENT 2
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC EPOCH
IG33_DS_DS_007 XXX DS XXX-767-001 1 COMPLETED COMPLETED DISPOSITION EVENT STUDY TREATMENT 2016-02-15 TREATMENT 1
IG33_DS_DS_007 XXX DS XXX-767-001 2 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-02-15 TREATMENT 1
IG33_DS_DS_007 XXX DS XXX-767-001 3 SKIN RASH ADVERSE EVENT DISPOSITION EVENT STUDY TREATMENT 2016-03-14 TREATMENT 2
IG33_DS_DS_007 XXX DS XXX-767-001 4 SKIN RASH ADVERSE EVENT DISPOSITION EVENT STUDY PARTICIPATION 2016-03-14 TREATMENT 2
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC EPOCH
IG33_DS_DS_008 XXX DS XXX-767-001 1 COMPLETED COMPLETED DISPOSITION EVENT BLINDED DRUG A 2016-02-15 TREATMENT 1
IG33_DS_DS_008 XXX DS XXX-767-001 2 COMPLETED COMPLETED DISPOSITION EVENT BLINDED DRUG B 2016-02-15 TREATMENT 1
IG33_DS_DS_008 XXX DS XXX-767-001 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-02-25 TREATMENT 1
IG33_DS_DS_008 XXX DS XXX-767-001 4 COMPLETED COMPLETED DISPOSITION EVENT BLINDED DRUG A 2016-03-14 TREATMENT 2
IG33_DS_DS_008 XXX DS XXX-767-001 5 COMPLETED COMPLETED DISPOSITION EVENT BLINDED DRUG B 2016-03-14 TREATMENT 2
IG33_DS_DS_008 XXX DS XXX-767-001 6 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-03-24 TREATMENT 2
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT EPOCH DSSTDTC
IG33_DS_DS_009 XXX DS XXX-767-001 1 INFORMED CONSENT FOR STUDY ENROLLMENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE SCREENING 2016-02-22
IG33_DS_DS_009 XXX DS XXX-767-001 2 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE SCREENING 2016-02-26
IG33_DS_DS_009 XXX DS XXX-767-001 3 INFORMED CONSENT FOR AMENDMENT ONE OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE TREATMENT 1 2016-04-12
IG33_DS_DS_009 XXX DS XXX-767-001 4 INFORMED CONSENT FOR PHARMACOGENETIC RESEARCH OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE TREATMENT 2 2016-06-08
IG33_DS_DS_009 XXX DS XXX-767-001 5 INFORMED CONSENT FOR PK SUB-STUDY OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE TREATMENT 2 2016-06-23
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC EPOCH
IG33_DS_DS_010 XYZ DS XYZ-767-001 1 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE 2016-02-13 SCREENING
IG33_DS_DS_010 XYZ DS XYZ-767-001 2 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-02-13 SCREENING
IG33_DS_DS_010 XYZ DS XYZ-767-001 3 COMPLETED COMPLETED DISPOSITION EVENT DRUG1 2016-03-13 TREATMENT 1
IG33_DS_DS_010 XYZ DS XYZ-767-001 4 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-03-14 TREATMENT 1
IG33_DS_DS_010 XYZ DS XYZ-767-001 5 COMPLETED COMPLETED DISPOSITION EVENT DG1INDG 2016-04-19 TREATMENT 2
IG33_DS_DS_010 XYZ DS XYZ-767-001 6 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-04-20 TREATMENT 2
IG33_DS_DS_010 XYZ DS XYZ-767-001 7 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-04-24 FOLLOW-UP
IG33_DS_DS_010 XYZ DS XYZ-767-002 1 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE 2016-02-20 SCREENING
IG33_DS_DS_010 XYZ DS XYZ-767-002 2 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-02-20 SCREENING
IG33_DS_DS_010 XYZ DS XYZ-767-002 3 COMPLETED COMPLETED DISPOSITION EVENT DRUG2 2016-03-23 TREATMENT 1
IG33_DS_DS_010 XYZ DS XYZ-767-002 4 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-03-24 TREATMENT 1
IG33_DS_DS_010 XYZ DS XYZ-767-002 5 COMPLETED COMPLETED DISPOSITION EVENT DG2INDG 2016-04-24 TREATMENT 2
IG33_DS_DS_010 XYZ DS XYZ-767-002 6 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-04-25 TREATMENT 2
IG33_DS_DS_010 XYZ DS XYZ-767-002 7 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2016-04-29 FOLLOW-UP
Example STUDYID DOMAIN USUBJID DSSEQ DSTERM DSDECOD DSCAT DSSCAT DSSTDTC TAETORD EPOCH
IG33_DS_DS_011 DS10 DS 101 1 INFORMED CONSENT OBTAINED INFORMED CONSENT OBTAINED PROTOCOL MILESTONE 2015-01-21 1 SCREENING
IG33_DS_DS_011 DS10 DS 101 2 RANDOMIZED RANDOMIZED PROTOCOL MILESTONE 2015-02-01 1 SCREENING
IG33_DS_DS_011 DS10 DS 101 3 COMPLETED COMPLETED DISPOSITION EVENT STUDY PARTICIPATION 2015-02-01 1 SCREENING
IG33_DS_DS_011 DS10 DS 101 4 Toxicity ADVERSE EVENT DISPOSITION EVENT DRUG C 2015-03-06 2 TREATMENT
IG33_DS_DS_011 DS10 DS 101 5 Disease progression PROGRESSIVE DISEASE DISPOSITION EVENT DRUGS A & B 2015-04-14 6 TREATMENT
IG33_DS_DS_011 DS10 DS 101 6 Disease progression PROGRESSIVE DISEASE DISPOSITION EVENT STUDY PARTICIPATION 2015-04-26 6 TREATMENT
IG33_DS_DS_011 DS10 DS 101 7 Death due to cancer DEATH DISPOSITION EVENT STUDY PARTICIPATION 2015-09-19 8 FOLLOW-UP
Example STUDYID DOMAIN USUBJID EXSEQ EXTRT EXDOSE EXDOSU EPOCH EXSTDTC EXENDTC
IG33_DS_EX_010 XYZ EX XYZ-767-001 1 Drug 1 500 mg TREATMENT 1 2016-02-14 2016-03-13
IG33_DS_EX_010 XYZ EX XYZ-767-001 2 Drug 1 500 mg TREATMENT 2 2016-03-14 2016-04-19
IG33_DS_EX_010 XYZ EX XYZ-767-001 3 Investigational Drug 1000 mg TREATMENT 2 2016-03-14 2016-04-19
IG33_DS_EX_010 XYZ EX XYZ-767-002 1 Drug 2 500 mg TREATMENT 1 2016-02-21 2016-03-23
IG33_DS_EX_010 XYZ EX XYZ-767-002 2 Drug 2 500 mg TREATMENT 2 2016-03-24 2016-04-24
IG33_DS_EX_010 XYZ EX XYZ-767-002 3 Investigational Drug 1000 mg TREATMENT 2 2016-03-24 2016-04-24
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_DS_RELREC_004 ABC123 DS 123102 DSSEQ 1 1
IG33_DS_RELREC_004 ABC123 AE 123102 AESEQ 1 1
Example STUDYID DOMAIN USUBJID SESEQ ETCD ELEMENT SESTDTC SEENDTC TAETORD EPOCH
IG33_DS_SE_010 XYZ SE XYZ-767-001 1 SCREEN Screen 2016-02-02 2016-02-14 1 SCREENING
IG33_DS_SE_010 XYZ SE XYZ-767-001 2 DRUG1 Drug-1 2016-02-14 2016-03-14 2 TREATMENT 1
IG33_DS_SE_010 XYZ SE XYZ-767-001 3 DG1INDG Drug 1 + Investigational Drug 2016-03-14 2016-04-24 3 TREATMENT 2
IG33_DS_SE_010 XYZ SE XYZ-767-001 4 FU Follow-up 2016-04-24 2016-04-24 4 FOLLOW-UP
IG33_DS_SE_010 XYZ SE XYZ-767-002 1 SCREEN Screen 2016-02-04 2016-02-21 1 SCREENING
IG33_DS_SE_010 XYZ SE XYZ-767-002 2 DRUG2 Drug-2 2016-02-21 2016-03-24 2 TREATMENT 1
IG33_DS_SE_010 XYZ SE XYZ-767-002 3 DG2INDG Drug 2 + Investigational Drug 2016-03-24 2016-04-29 3 TREATMENT 2
IG33_DS_SE_010 XYZ SE XYZ-767-002 4 FU Follow-up 2016-04-29 2016-04-29 4 FOLLOW-UP
Example STUDYID DOMAIN USUBJID SESEQ ETCD SESTDTC SEENDTC SEUPDES TAETORD EPOCH
IG33_DS_SE_011 DS10 SE 101 1 SCRN 2015-01-21 2015-02-01 0 SCREENING
IG33_DS_SE_011 DS10 SE 101 2 ABC 2015-02-01 2015-03-01 1 TREATMENT
IG33_DS_SE_011 DS10 SE 101 3 ABC 2015-03-01 2015-03-29 2 TREATMENT
IG33_DS_SE_011 DS10 SE 101 4 AB 2015-03-29 2015-04-26 6 TREATMENT
IG33_DS_SE_011 DS10 SE 101 5 FU 2015-04-26 2015-09-19 8 FOLLOW-UP
Example STUDYID DOMAIN ARMCD ARM TAETORD ETCD ELEMENT TABRANCH TATRANS EPOCH
IG33_DS_TA_010 XYZ TA DG1INDG Drug-1+Investigation-Drug 1 SCRN Screen Randomized to DG1INDG SCREENING
IG33_DS_TA_010 XYZ TA DG1INDG Drug-1+Investigation-Drug 2 DRUG1 Drug-1 TREATMENT 1
IG33_DS_TA_010 XYZ TA DG1INDG Drug-1+Investigation-Drug 3 DG1INDG Drug 1 + Investigation Drug TREATMENT 2
IG33_DS_TA_010 XYZ TA DG1INDG Drug-1+Investigation-Drug 4 FU Follow-up FOLLOW-UP
IG33_DS_TA_010 XYZ TA DG2INDG Drug-2+Investigation-Drug 1 SCRN Screen Randomized to DG2INDG SCREENING
IG33_DS_TA_010 XYZ TA DG2INDG Drug-2+Investigation-Drug 2 DRUG2 Drug-2 TREATMENT 1
IG33_DS_TA_010 XYZ TA DG2INDG Drug-2+Investigation-Drug 3 DG2INDG Drug 2 + Investigation Drug TREATMENT 2
IG33_DS_TA_010 XYZ TA DG2INDG Drug-2+Investigation-Drug 4 FU Follow-up FOLLOW-UP
Example STUDYID DOMAIN ARMCD ARM TAETORD ETCD ELEMENT TABRANCH TATRANS EPOCH
IG33_DS_TA_011 DS10 TA AB AB 0 SCRN Screen Randomized to AB SCREENING
IG33_DS_TA_011 DS10 TA AB AB 1 AB Trt AB If disease progression, go to follow-up epoch. TREATMENT
IG33_DS_TA_011 DS10 TA AB AB 2 AB Trt AB If disease progression, go to follow-up epoch. TREATMENT
IG33_DS_TA_011 DS10 TA AB AB 3 AB Trt AB If disease progression, go to follow-up epoch. TREATMENT
IG33_DS_TA_011 DS10 TA AB AB 4 AB Trt AB TREATMENT
IG33_DS_TA_011 DS10 TA AB AB 5 FU Follow-up FOLLOW-UP
IG33_DS_TA_011 DS10 TA ABC ABC 0 SCRN Screen Randomized to ABC SCREENING
IG33_DS_TA_011 DS10 TA ABC ABC 1 ABC Trt ABC If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "5". TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 2 ABC Trt ABC If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "6". TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 3 ABC Trt ABC If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "7". TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 4 ABC Trt ABC Go to follow-up epoch. TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 5 AB Trt AB TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 6 AB Trt AB TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 7 AB Trt AB TREATMENT
IG33_DS_TA_011 DS10 TA ABC ABC 8 FU Follow-up FOLLOW-UP
Example STUDYID DOMAIN ETCD ELEMENT TESTRL TEENRL TEDUR
IG33_DS_TE_010 XYZ TE SCRN Screen Informed Consent 1 week after start of Element P7D
IG33_DS_TE_010 XYZ TE DRUG1 Drug 1 First dose of Drug 1 4 weeks after start of Element P28D
IG33_DS_TE_010 XYZ TE DRUG2 Drug 2 First dose of Drug 2 4 weeks after start of Element P28D
IG33_DS_TE_010 XYZ TE DG1INDG Drug 1 + Investigation Drug First dose of Investigational Drug, where Investigational Drug is given with Drug 1. 1 week after start of Element P7D
IG33_DS_TE_010 XYZ TE DG2INDG Drug 2 + Investigation Drug First dose of Investigational Drug, where Investigational Drug is given with Drug 2. 1 week after start of Element P7D
IG33_DS_TE_010 XYZ TE FU Follow-up One day after last administration of study drug.
Example STUDYID DOMAIN ETCD ELEMENT TESTRL TEENRL TEDUR
IG33_DS_TE_011 DS10 TE SCRN Screen Informed Consent Screening assessments are complete, up to 2 weeks after start of Element
IG33_DS_TE_011 DS10 TE AB Trt AB First dose of treatment Element, where treatment is AB 4 weeks after start of Element P4W
IG33_DS_TE_011 DS10 TE ABC Trt ABC First dose of treatment Element, where treatment AB +C 4 weeks after start of Element P4W
IG33_DS_TE_011 DS10 TE FU Follow-up Four weeks after start of last treatment element Death, withdrawal of consent, or loss to follow-up.