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 |
|---|---|---|---|---|---|---|---|
MedDRA
|
Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies (such as COSTART and ICD9) used in the medical product
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PD
|
Pharmacodynamics. The effect of the drug on physiological measures in the subject.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PK
|
Pharmacokinetics. The study of the absorption, distribution, metabolism and excretion of a drug.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
QD
|
Every Day (Latin: quaque die)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SDS
|
Submission Data Standards. Also the name of the Team that created the SDTM and SDTMIG
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SDTMIG
|
Submission Data Standards SDTM Implementation Guide for Human Clinical Trials (this document)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SEND
|
Standard for Exchange of Non-Clinical Data
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SF-36
|
A multi-purpose, short-form health survey with 36 questions
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SNOMED
|
Systematized Nomenclature of Medicine (a dictionary)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SOC
|
CDISC System Organ Class --BODSYS Populated using a code value in the list of controlled terms, codelist SOC (C66783) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
TID
|
Three Times Daily (Latin: ter in die)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
TMAX
|
The time after dosing when Cmax occurs (PK) or when the maximum effect is observed (PD)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
UUID
|
Universally Unique Identifier V3.x Version 3.1 of the SDSIG and all subsequent versions of the SDTMIG
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
WHODRUG
|
World Health Organization Drug Dictionary
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 274
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Treatment
|
--CAN Populated using a code value in the list of controlled terms, codelist ACN (C66767) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Age Unit
|
Populated using a code value from the list of controlled terms, codelist AGEU (C66781) at http://www.cdisc.org/standards/terminology/index.html Units are associated with
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AESEV
|
Populated using a code value in the list of controlled terms, codelist AESEV (C66769) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ETHNIC
|
Will be changed to Subject Ethnic Group in the future
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Form
|
--DOSFRM Populated using a code value in the list of controlled terms, codelist FRM (C66726) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Size
|
Controlled Terms for when VSTESTCD = FRMSIZE (Frame Size) Populated using a code value in the list of controlled terms, codelist SIZE (C66733) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
IECAT
|
Populated using a code value in the list of controlled terms, codelist IECAT (C66797) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBTESTCD
|
Populated using a code value in the list of controlled terms, codelist LBTESTCD (C65047) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LBTEST
|
Populated using a code value in the list of controlled terms, codelist LBTEST (C65154) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
See also LBTESTCD
|
CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 276
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Non-Completion
|
DSDECOD when DSCAT = “DISPOSITION EVENT” Populated using a code value in the list of controlled terms, codelist NCOMPLT (C66727) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
No Yes Response
|
--PRESP, --OCCUR, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE, --CONTRT, --BLFL, --FAST, --DRVFL, ADDON (Trial Summary Parameter) Populated using a code value in the list of controlled terms, codelist NY (C66742) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Outcome of Event
|
--OUT Populated using a code value in the list of controlled terms, codelist OUT (C66768) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ROUTE
|
Route of Administration --ROUTE Populated using a code value in the list of controlled terms, codelist ROUTE (C66728) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
SEX
|
Populated using a code value in the list of controlled terms, codelist SEX (C66731) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSTESTCD
|
Populated using a code value in the list of controlled terms, codelist VSTESTCD (C66741) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
VSTEST
|
Populated using a code value in the list of controlled terms, codelist VSTEST (C67153) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
See also VSTESTCD
|
CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Applicable
|
Added as a “restricted prefix” and variable naming prefix - see Appendix D. Do not use as a Domain Code. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Events
|
Evidence of disease or condition, including objective signs and subjective symptoms that are typically observed by a physician or described to the investigator by the subject.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Findings
|
Semi-Quantitative measurement of vertebral fractures CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Purpose
|
See SDTM 3.3. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 278
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Meal Data
|
Interventions Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for PK analysis. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
will not be used with
|
SDTM standard domains, where - may be any valid letter or number. CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 280
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Autopsy
|
TBD (To Be Determined) Additional data about deaths, specific to findings from autopsies.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Under Discussion
|
Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Under Development
|
Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 282
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Treatments
|
Populated using a code value from the list of controlled terms, codelist No Yes Response (C66742) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DO NOT USE -
|
Information on dictionaries and dictionary versions be
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
included in the SDTM
|
metadata, since the define.xml specification has explicit mechanisms for handling references to dictionaries and dictionary versions. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
at
|
http://www.cdisc.org/standards/terminology/index.html CDISC SDTM Implementation Guide (Version 3.1.2) APPENDIX C4: DRUG ACCOUNTABILITY TEST CODES The following table contains the test codes suggested by CDISC for use in DRUG Accountability domains.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
of Subjects
|
No controlled terminology. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Age Group
|
Populated using a code value from the list of controlled terms, codelist AGESPAN (C66780) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
A record for each
|
applicable category should be included. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
AGEMAX
|
Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Name
|
No controlled terminology. In the future, may be added to list of controlled terms on CDISC website.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Administration
|
(ROUTE) Includes many more controlled terms than for those listed in CDISC Notes for – ROUTE. Includes more specific routes than INHALATION listed in CDISC notes for SUROUTE on page 50.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
to submit dosing
|
parameters, as the TE and TA datasets are better suited to describing such information. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Frequency
|
Use controlled terminology for interventions (DOSFRQ). Dose frequency associated with a test product or comparative treatment. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Dose Units
|
Use controlled terminology for interventions (DOSU). Units used with value(s) in DOSE. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Indication
|
No controlled terminology. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Length
|
No controlled terminology. Defined as the planned
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
length of time for a
|
subject's participation. It should be recorded using
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
the IS8601 format for
|
durations, see Section 4.1.4.3. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 284
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Objective
|
No controlled terminology Should be described in
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
terms of the desired
|
statement in labeling. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Subjects
|
No controlled terminology. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Randomized
|
Populated using a code value from the list of controlled terms, codelist NY (C66742) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Participants
|
Populated using a code value from the list of controlled terms, codelist SEXPOP (C66732) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Organization
|
No controlled terminology. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Rules
|
If the trial has study stop rules (STOPRULE is not equal to "NONE"), contains a description of the stop rules. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Schema
|
Populated using a code value from the list of controlled terms, codelist TPLIND (C66735) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Control Type
|
Populated using a code value from the list of controlled terms, codelist TCNTRL (C66785) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Group
|
Populated using a code value from the list of controlled terms, codelist TDIGRP (C66787) at http://www.cdisc.org/standards/terminology/index.html If trial does not enroll healthy subjects (TDIGRP is not equal to "HEALTHY SUBJECTS"), contains the diagnosis of subjects to be enrolled. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Type
|
Populated using a code value from the list of controlled terms, codelist TINDTP (C66736) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
TINDTP provides a
|
classification system for the indication provided as text in INDIC.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
the adverse effect of
|
another treatment. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Classification
|
Populated using a code value from the list of controlled terms, codelist TPHASE (C66737) at http://www.cdisc.org/standards/terminology/index.html The controlled terminology for phase includes several formats as synonyms. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
of Test Product
|
No controlled terminology. In the future, may be added to list of controlled terms on CDISC website
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Type
|
Populated using a code value from the list of controlled terms, codelist TTYPE (C66739) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Returned Amount
|
APPENDIX C5: SUPPLEMENTAL QUALIFIERS NAME CODES The following table contains an initial set of standard name codes for use in the Supplemental Qualifiers (SUPP--) special-purpose datasets. There are no specific conventions for naming QNAM and some sponsors may choose to include the 2- character domain in the QNAM variable name. Note that the 2-character domain code is not required in QNAM since it is present in the variable RDOMAIN in the SUPP-- datasets.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Dictionary Version
|
AE, MH, PE and other domains that use dictionary-
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
High Level Group Term
|
AE, MH, PE, and any other domain coded to MedDRA --HLT
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
High Level Term
|
AE, MH, PE, and any other domain coded to MedDRA --LLT
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Lower Level Term
|
AE, MH, PE, and any other domain coded to MedDRA
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ITT
|
Intent to Treat Population Flag
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 286
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
RL
|
CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 288
|
CDISC. © 2007. All rights reserved July 25, 2007
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
General
|
Changed abbreviation from SDSIG to SDTMIG . Updated references to SDTM v1.1. Introduced abbreviation of V3.x to refer to V3.1 IG and subsequent versions.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Change
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Controlled Terminology - Type of Trial (TTYPE) 1) TSPARMCD was changed from TYPE on page 170 to TTYPE. 2) TSVAL CONFIRMATORY and EXPLORATORY were removed based on review comments. 3) TSVAL PHARMACODYNAMICS changed to PHARMACODYNAMIC 4) TSVAL PHARMACOGENOMICS changed to PHARMACOGENOMIC TSVAL PHARMACOKINETICS changed to PHARMACOKINETIC
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Add
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10.3.1 Added SI Infection Site Measurements to domain codes.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Document
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New Pharmacokinetics Parameters domain model and example
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Correct
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10.4 Corrected list of fragments (Domain codes are no longer included in this fragment list, but appear only in 10.3.1). E4: CHANGES FROM CDISC SDTMIG V3.1.1 TO V3.1.2 DRAFT Note: This is limited to Appendix 10 changes as of current printing.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Sections 5
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& 6 Changed the header for all domain models to use lowercase xpt filenames for consistency with eCTD specifications.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Section 6
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Changed domain models for CM, SU, AE, MH to address possible use of new SUPP-- variable --PRESP, reconsider use of --OCCUR, and emphasize importance of including data that represents actual interventions or events.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Page 290
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CDISC. © 2007. All rights reserved July 25, 2007
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Page 292
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CDISC. © 2007. All rights reserved July 25, 2007
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[
"SDTM.pdf"
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SDTM.pdf
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pdf
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glossary.json
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move
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6.1.1.0 Added new assumption 5 to discuss record structure. Removed old assumption 5 (which was redundant with Notes and Section 4.1.4.7.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
Replace
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9.5.1 Replaced Trial Design examples with new examples to better communicate core concepts; added new TS example.
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[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
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