term
stringlengths 2
142
⌀ | 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 |
|---|---|---|---|---|---|---|---|
Row 11
|
Shows derived records. Notice how QSORRES is blank for derived records because there is no corresponding text value for the numeric value shown (see Section 4.1.1.7.1). In this study, QSTPTNUM is an arbitrary number, sponsor defined to aid in sorting.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 12
|
The TEST "Interpretation" (i.e., the interpretation of the ECG strip as a whole), is "ABNORMAL ". CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Screening 1
|
2003-04-15T11:58 -36 ECG Example 1 SUPPEG dataset
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 132
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SCREEN I
|
-2 2003-11-26 -2 2 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SCREEN II
|
-1 2003-11-27 -1 3 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DAY 10
|
10 2003-12-07T09:02 10 4 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DAY 15
|
15 2003-12-12 15 CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 134
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char IE
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
IESPID
|
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: Inclusion or Exclusion criteria number from CRF.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
INCL03
|
Acceptable mammogram from local radiologist?
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
WEEK -8
|
-56 1999-01-12 -56 4 (cont) 1
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 136
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char LB
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBSCAT
|
Subcategory for Lab Test Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 138
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBTOXGR
|
Standard Toxicity Grade Num *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 140
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 2-4
|
Show two records for Alkaline Phosphatase done at the same visit, one day apart. Row 4 shows how to create a derived record (average of the records 2 and 3) and flagged derived (LBDRVFL = “Y”) and as the record to use as baseline (LBBLFL = “Y”).
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 6 and 7
|
Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (i.e., “DIFFERENTIAL”).
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DIFFERENTIAL
|
5.1 10^9/L 2 8 5.1 5.1 8
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Urinalysis
|
7.5 5.0 9.0 7.5 9
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBDTC
|
1 (cont) g/dL 3.5 5
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 1
|
Shows an example of a pre-dose urine collection interval (from 4 hours prior to dosing until 15 minutes prior to dosing) with a negative value for LBELTM that reflects the end of the interval in reference to the fixed reference LBTPTREF, the date of which is recorded in LBRFTDTC.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 2 and 3
|
Show an example of post-dose urine collection intervals with values for LBELTM that reflect the end of the intervals in reference to the fixed reference LBTPTREF, the date of which is recorded in LBRFTDTC.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VISITNUM
|
Row 1 (cont) 0.38 0.38 mmol/L 0.1 0.8
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
INITIAL DOSING
|
2 Row 3 (cont) 0.5 0.5 mmol/L 0.1 0.8
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBRFTDTC
|
Row 1 (cont) 1999-06-19T04:00 1999-06-19T07:45
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Dosing
|
1999-06-19T08:00 LB Example 3: This is an example of pregnancy test records, one with a result and one with no result because the test was not performed due to the subject being male.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 142
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char PE
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PESPID
|
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.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PECAT
|
Category for Examination Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 144
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VISITDY
|
Planned Study Day of Visit Num
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PEDTC
|
Date/Time of Examination Char ISO 8601
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PEDY
|
Study Day of Examination Num
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 4-6
|
Show how PESPID is used to show the sponsor-defined identifier, which in this case is a sequence number used for identifying abnormalities within a body system.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rows 4-7
|
Show how PESTRESC is populated if abnormality is dictionary coded. Rows 8, 13 Show how the PECAT variable can be used to indicate a different type of physical examination. In this case, the ophthalmologic examination may have been collected in a separate dataset in the operational database.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
BASELINE
|
1 1999-06-19 1 12 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VISIT 1
|
35 1999-07-21 33 CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 146
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char QS
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
QSSCAT
|
Subcategory for Question Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
QSORRES
|
Finding in Original Units Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 148
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 150
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
GH11C
|
Expect health to get worse
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
RP4A
|
Phys. Health-cut down time spent
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
RP4C
|
Phys. Health-limit kind of work
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SCREENING
|
-14 2001-03-20 -10 1 11 (cont) 9
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 152
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char SC
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SCSPID
|
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. Perm SDTM 2.2.4 SCTESTCD Subject Characteristic
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 154
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SCDY
|
Study Day of Examination Num
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CQH
|
1999-06-14 CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 156
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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. Perm SDTMIG 2.4.4
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSSPID
|
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.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSCAT
|
Category for Vital Signs Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSSCAT
|
Subcategory for Vital Signs Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 158
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSDY
|
Study Day of Vital Signs
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSTPT
|
Planned Time Point Name Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 14
|
Shows a value collected in one unit, but converted to selected standard unit.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 15
|
Shows the proper use of the STAT 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 |
VSPOS
|
VSORRES VSORRESU VSSTRESC VSSTRESN VSSTRESU 1
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
BASELINE BASELINE 1
|
1 1 1999-06-19T08:45 1 9 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
BASELINE BASELINE 2
|
2 1 1999-06-19T09:00 1 10 (cont)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 160
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char DA
|
Identifier Two-character abbreviation for the domain most relevant to the observation.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DACAT
|
Category of Assessment Char *
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DA Example 1
|
Example 1 below shows drug accounting for a study with two study meds and one rescue med, all of which are measured in tablets. The sponsor has chosen to add EPOCH from the list of timing variables and to use DASPID and DAREFID for code numbers that appear on the label.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DISPAMT
|
Amount Dispensed Rescue Medication 6
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
TABLETS
|
Study Med Period 1 2004-07-15
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DA Example 2
|
Example 2 is for a study where drug containers, rather than their contents, are being accounted for and the sponsor did not track returns. In this case, the purpose of the accountability tracking is to verify that the containers dispensed were consistent with the randomization. The sponsor has chosen to use DASPID to record the identifying number of the container dispensed or returned.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 162
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char MB
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MBSPID
|
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: Organism identifier. For organism identification, MBSPID would remain the same each time the same organism is identified in a new specimen.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 164
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MBTPT
|
Planned Time Point Name Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
The use of GRPID to relate MS to MB greatly simplifies RELREC because only two records are needed in RELREC to describe the relationship of
|
MB to the many related records in MS. With this method there is no need to create detailed relationships at the subject level. Other standard methods of relating records can also be used, but will produce a more complicated RELREC requiring detail of the relationships by subject. For example, if MBSEQ and MSSEQ are used, then RELREC would contain records for each specimen's MBSEQ, and all of the related MS findings by MSSEQ, for every subject.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 166
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Char MS
|
Identifier Two-character abbreviation for the domain.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MSSPID
|
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.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 168
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MSTPT
|
Planned Time Point Name Char
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 170
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 6
|
Shows no organisms have grown from this specimen at Visit 3. Therefore the organism recorded is "NO GROWTH".
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Row 1-6
|
Show MBMETHOD being used for reporting the method of testing the sample, e.g. GRAM STAIN or CULTURE PLATE. Microbiology Example 1 MB dataset
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
GRAM STAIN
|
1 2005-06-19T08:00 2 (cont) 2+ FEW
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CULTURE PLATE
|
3 2005-07-06T08:00 If the method of the collection of the sputum is reported (e.g., EXPECTORATION or BIOPSY), this information would go into SUPPMB. suppmb.xpt
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
QUADRANT
|
>=30 COLONIES IN 2ND QUADRANT 1 5 (cont) 0.125 mcg/mL 0.125 0.125 mcg/mL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
E-TEST
|
Example 5: RELREC to relate MB and MS Row 1, 2 - Show the one-to-many relationship between MB and MS. For any organism found in a microbiology specimen and recorded in MB, there may be multiple findings about that organism recorded in MS. The organism in MB can be linked to its findings in MS because MBGRPID=MSGRPID for any organism within a subject.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 172
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
MSMETHOD
|
1 (cont) 0.25 mcg/mL 0.25 mcg/mL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
BROTH DILUTION
|
4 (cont) 0.5 mcg/mL 0.5 mcg/mL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ZONE SIZE
|
7 (cont) 0.25 mcg/mL 0.25 mcg/mL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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