term
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⌀ | definition
stringlengths 9
116k
⌀ | sources
listlengths 1
1
⌀ | source
stringclasses 48
values | type
stringclasses 5
values | file
stringclasses 26
values | sheet
stringclasses 3
values | text
stringclasses 212
values |
|---|---|---|---|---|---|---|---|
SUSPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a Tobacco & Alcohol use CRF page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 94
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SUROUTE
|
Route of Administration Char (ROUTE)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SUDUR
|
Duration of Substance Use Char ISO 8601
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SUSTTPT
|
Start Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SUENTPT
|
End Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 96
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ONGOING
|
2 (cont) 2006-01-01 2006-01-01 3 (cont) 2006-03-15
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
BEFORE
|
2003 4 (cont) 2006-03-15 2006-03-15 5 (cont) 2006-03-15 2006-03-15 6 (cont) Subject left office before CRF was completed 7 (cont) Subject left office before CRF was completed CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 98
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char AE
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AESPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. It may be pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on an Adverse Events page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AELOC
|
Location of the Reaction Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEPATT
|
Pattern of Adverse Event Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEOUT
|
Outcome of Adverse Event Char (OUT)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 100
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AESOD
|
Occurred with Overdose Char (NY)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AETOXGR
|
Populated using a code value in the list of controlled terms, codelist TOXGR (C66784) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEDUR
|
Duration of Adverse Event Char ISO 8601
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Period
|
--ROUTE Please see Section 4.1.4.7 “Use of RELATIVE Timing Variables --STRF, --STTPT, --STRTPT, --ENRF, --ENTPT, AND --ENRTPT” for specific regarding controlled terminology for these variables. Populated using a code value in the list of controlled terms, codelist STENRF (C66728) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEENTPT
|
End Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 102
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AE Structure
|
The structure of the AE domain is one record per adverse event per subject. It is the sponsor's responsibility to define an event. This definition may vary based on the sponsor's requirements for characterizing and reporting product safety and is usually described in the protocol. For example, the sponsor may submit one record that covers an adverse event from start to finish. Alternatively, if there is a need to evaluate AEs at a more granular level, a sponsor may submit a new record when severity, causality, or seriousness changes or worsens. By submitting these individual records, the sponsor indicates that each is considered to represent a different event. The submission dataset structure may differ from the structure at the time of collection. For example, a sponsor might collect data at each visit in order to meet operational needs, but submit records that summarize the event and contain the highest level of severity, causality, seriousness, etc. Examples of dataset structure: 1. One record per adverse event per subject for each unique event. Multiple adverse event records reported by the investigator are submitted as summary records “collapsed” to the highest level of severity, causality, seriousness, and the final outcome. 2. One record per adverse event per subject. Changes over time in severity, causality, or seriousness are submitted as separate events. Alternatively, these changes may be submitted in a separate dataset based on the CF model (see Section 6.3.11). 3. Other approaches may also be reasonable as long as they meet the sponsor's safety evaluation requirements and each submitted record represents a unique event. The domain-level metadata (See Section 3.2.2) should clarify the structure of the dataset. 8. Additional Events Qualifiers The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred. See Assumption 4c above for information on how to deal with negative responses or missing responses to probing questions for pre-specified adverse events. CDISC SDTM Implementation Guide (Version 3.1.2) 6.2.1.2 EXAMPLES FOR ADVERSE EVENTS DOMAIN MODEL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1 and 2
|
Show the following: -an example of modifying the reported term for coding purposes. The modified value is in AEMODIFY. -an example of the overall seriousness question AESER answered with an “N” and corresponding seriousness category variables (e.g., AESDTH, AESHOSP) left blank.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 3
|
Shows a date/time in ISO 8601 representation where both the date and time were collected. Rows 4-5 Show where EGGRPID is used to group related results.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AE
|
--CLSIG Clinically Significant (include domain prefix)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEREL
|
1 (cont) Nervous system disorders
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
NOT APPLICABLE
|
DEFINITELY NOT RELATED 2 (cont) Musculoskeletal and connective tissue disorders
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AEENRF
|
1 (cont) RECOVERED/RESOLVED -1 -1 2 (cont) RECOVERED/RESOLVED 1 1 3 (cont) RECOVERING/RESOLVING
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 104
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1and 2
|
Show that nausea and vomiting were pre-specified on a CRF, as indicated by AEPRESP = “Y”. The subject did not experience diarrhea, so no record for that term exists in the AE dataset.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 3
|
Shows an example of an AE (headache) that is not pre-specified on a CRF as indicated by a blank for AEPRESP
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
RELATED
|
RECOVERED/RESOLVED 2005-10-13T13:00 2005-10-13T19:00 3 3 3 (cont) DOSE NOT CHANGED
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
POSSIBLY RELATED
|
RECOVERED/RESOLVED 2005-10-21 2005-10-21 11 11
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Example 3
|
This is an example of how the language used for a questionnaire might be represented. The parent domain (RDOMAIN) is QS, and IDVAR is QSCAT. QNAM holds the name of the Supplemental Qualifier variable being defined (QSLANG). The language recorded in QVAL applies to all of the subject’s records where IDVAR (QSCAT) equals the value specified in IDVARVAL . In this case, IDVARVAL has values for two questionnaires (SF36 and ADAS) for two separate subjects. QVAL identifies the questionnaire language version (French or German) for each subject. CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
disorders
|
2005-10-29 19 CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Example 4
|
The following example illustrates how data that may have been represented in an operational database as a single domain can be expressed using an Events general-observation-class dataset and a Supplemental Qualifiers dataset. Original Operational (non-SDTM) Dataset:
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 1
|
Shows extent of growth of Organism 1 found at Visit 1 in specimen 1 ( MBGRPID=1, Row 3 in MB example above). Rows 2, 3 Show results of susceptibility testing on Organism 1 found at Visit 1 in specimen 1 (MBGRPID=1, Row 3 in MB example above).
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 2-6
|
Show the data in original units of measure in EGORRES, EGSTRESC, and EGSTRESN. See Section 4.1.5.1 for additional examples for the population of Result Qualifiers.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 106
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char DS
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DSSPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a Disposition page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 108
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DS Definition
|
a. The Disposition dataset provides an accounting for all subjects who entered the study and may include protocol milestones, such as randomization, as well as the subject's completion status or reason for discontinuation for the entire study or each phase or segment of the study, including screening and post-treatment follow up. Sponsors may choose which disposition events and milestones to submit for a study. See ICH E3, Section 10.1 for information about disposition events. 2. DS Description and Coding a. DSTERM and DSDECOD are required. DSDECOD values are drawn from sponsor-defined controlled terminology. The controlled terminology will depend on the value of DSCAT. When DSCAT="DISPOSITION EVENT", DSTERM contains either "COMPLETE" or, if the subject did not complete, specific verbatim information about the disposition event. b. When DSTERM = "COMPLETE", DSDECOD = "COMPLETE". When DSTERM contains verbatim text, DSDECOD will contain a standard term from a controlled terminology list. For example, DSTERM = "Subject moved" might map to "LOST TO FOLLOW-UP" in the sponsor's controlled terminology. c. A sponsor may collect one disposition event for the trial as a whole, or they may collect disposition for each Epoch of the trial. When disposition is collected for each Epoch, the variable EPOCH should be included in the DS dataset. When EPOCH is populated for disposition events (records with DSCAT = DISPOSITION EVENT), EPOCH is the name of the Epoch whose disposition is described in the record. This is a subtly different meaning from that of EPOCH when it is used in other Events general-observation-class domains, where EPOCH, as a timing variable, is the name of the Epoch during which --STDTC occurs. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2. d. When DSCAT="PROTOCOL MILESTONE", DSTERM and DSDECOD will contain the same value drawn from the sponsor's controlled terminology. Examples of controlled terms include "INFORMED CONSENT OBTAINED" and "RANDOMIZED." EPOCH should not be populated when DSCAT = 'PROTOCOL MILESTONE'. e. Events that are not disposition or milestone related are classified as an “OTHER EVENT.” “TREATMENT UNBLINDED” is a common example of “OTHER EVENT.” CDISC SDTM Implementation Guide (Version 3.1.2) 3.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 110
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DS
|
456102 1 SUBJECT TAKING STUDY MED
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DISPOSITION EVENT
|
2003-10-15 Disposition Example 3: Rows 1, 2 Subject completed the treatment and follow-up phase Rows 3, 5 Subject did not complete the treatment phase but did complete the follow-up phase.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 4
|
Shows extent of growth of Organism 2 found at Visit 1 in specimen 1 (MBGRPID=2, Row 4 in MB example above). Rows 5, 6 Show results of susceptibility testing on Organism 2 found at Visit 1 in specimen 1 (MBGRPID=2, Row 4 in MB example above).
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 112
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PHASE
|
2003-09-29 2003-09-29 Adverse Event (AE) Dataset:
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AESMIE
|
1 (cont) DEFINITELY NOT RELATED
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
RELREC Dataset
|
Rows 1-5 identify the records that participate in the relationship with RELID=1. Rows 1-4 identify the four CF records, and Row 5 identifies the AE record. Rows 6-8 identify the records that participate in the relationship with RELID=2. Rows 6 and 7 identify the two CF records, and Row 8 identifies the AE record.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AESEQ
|
2 2 CDISC SDTM Implementation Guide (Version 3.1.2) 7 Trial Design Datasets 7.1
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 114
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char MH
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MHSPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a Medical History page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MHENTPT
|
End Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 116
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Value of MHSTAT
|
Spontaneously reported event occurred Pre-specified event occurred
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1-3
|
MHENRF has been populated based on the response to the "Ongoing at Study Start" question on the General Medical History CRF. If "Yes" is specified, MHENRF="DURING/AFTER;" if "No" is checked, MHENRF="PRIOR." See Section 4.1.4.7 for further guidance on using --STRF and --ENRF.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 5
|
Shows the organism assigned as ORG02 is still present in Specimen 2 at Visit 2.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Example 1 data
|
Row STUDYID DOMAIN USUBJID MHSEQ
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MH
|
101003 4 TRANSIENT ISCHEMIC ATTACK
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 118
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1-10
|
MHPRESP values of 'Y' indicate that each condition was pre-specified on the CRF. The presence or absence of a condition is documented with MHOCCUR. The data are collected as part of the Screening visit. Rows 1-3, 7, 9 The absence of a condition is documented with MHOCCUR. Rows 4-6, 8 The presence of a condition is documented with MHOCCUR.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 10
|
The subject had cholesterol measured. The normal range for this test is <200 mg/dL. The value <200 may not be used in the normal range variables LBORNRHI or LBSTNRHI; however, a sponsor may decide, for example, to enter '0' into LBORNRLO and '199' in LBORNRHI. The sponsor must define the appropriate value for all of the normal range variables. Row 1, 6 The SUPPLB dataset example shows clinical significance assigned by the investigator for test results where LBNRIND (reference range indicator) is populated. Lab Example 1 LB dataset
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 5-9
|
MHCAT indicates that these terms were reported on the RISK FACTORS page. These terms are not coded.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 5- 8
|
MHPRESP values of 'Y' indicate that each risk factor was pre-specified on the CRF. MHOCCUR is populated with Y or N corresponding to the CRF response to the questions for the 4 pre-specified risk factors.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 9
|
Shows the proper use of the LBSTAT variable to indicate "NOT DONE", where a reason was collected when a test was not done.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 120
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char DV
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DVSPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a CRF page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1 and 3
|
Show examples of a TREATMENT DEVIATION type of protocol deviation. This type of deviation is categorized as MAJOR (DVCAT) for this study.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 2
|
Shows the proper use of the STAT variable to indicate "NOT DONE", and when PEREASND is used to indicate why a body system (PETEST) was not examined.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 4 and 5
|
Shows an example of VISIT OUTSIDE WINDOW, which is considered to be a MINOR (DVCAT) deviation for this study. Row STUDYID DOMAIN USUBJID DVSEQ
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DV
|
123103 4 VISIT 3 MORE THAN 3 DAYS OUT OF
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 122
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char CE
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CESPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a CRF page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CECAT
|
Category for Clinical Event Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CEOCCUR
|
Clinical Event Occurrence Char (NY)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 124
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CESTTPT
|
Start Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CEENTPT
|
End Reference Time Point Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Value of CESTAT
|
Spontaneously reported event occurred Pre-specified event occurred
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Conjunctivitis
|
Example 1 Data: Rows 1-3 Show records for clinical events for which start dates were recorded. Since conjunctivitis was not observed, no start date was recorded and there is no CE record.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 126
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Diarrhea
|
Row 1 shows the record for a Nausea probing question answered "Yes". Since Nausea is a pre-specified adverse event, the AE domain will contain a record for this event. Row 2 shows the record for a Vomiting probing question answered "No". Row 3 shows the record for a Diarrhea probing question with an answer of "NOT DONE".
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SEVERE
|
2005-10-09 2005-10-11 CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 128
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char EG
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
EGSPID
|
Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the ECG page.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
EGPOS
|
ECG Position of Subject Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
EGXFN
|
ECG External File Name Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 130
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
EGTPT
|
Planned Time Point Name Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1-6
|
Show how ECG measurements are represented.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 2-10
|
Show how EGCAT could be used to group the intervals and the findings.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 5-6
|
Show QTCB and QTCF. The data shows a “Y” in the EGDRVFL column since these results are derived by the sponsor in this example.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 7-10
|
Show how ECG findings are represented.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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