is03: an introduction to sdtm – part ii · – conventions for values are sponsor-defined. –...
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IS03: An Introduction to SDTM – Part II
Jennie Mc Guirk
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SDTM Framework
1. Where should the data go?
2. What type of information should
it contain?
3. What is the minimum information needed?
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SDTM Framework: Re-cap
Data Class General Observation
Special Purpose
Relationship
Trail Design
Variable Role Identifier
Topic
Timing
Qualifier
Core Variables
Required
Expected
Permissible
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SDTM Small print
• Naming Conventions • Subject Identifiers
• Sequence Variable
• Relationships and Linking
• Controlled Terminology
• Dates Formats
• Reference Start Date & Study Days
• Handling Text
• Original & Standard Results
• Missing & Multiple Values
• Timing and Timepoints
• Splitting Domains
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Naming Conventions - Datasets
• 2 letter code, exceptions – Split domains – SUPP & RELREC
• SDTM IG Appendix C2, 30 SDTM reserved codes – Events (5): AE, CE, MH, DS, DV – Findings (12): EG, IE, LB, PC, PE, PP, QS, VS, DA, MB, MS, SC – Findings About (1): FA – Interventions (3): CM, EX, SU – Trial Design (5): TA, TE, TI, TS, TV – Special Purpose (4): CO, DM, SE, SV
• 1 reserved code relative to analysis datasets (AD)
• SDTM IG has also reserved the code X-, Y-, Z- for sponsor defined domains use / custom domains
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Naming Conventions - Variables
• 8 character limit (40 character label limit) • IG defines variables names per dataset class
• where ‘--’ indicates the domain name
• Fragment names (Appendix D) – Guideline for SUPP QNAMs and TESTCDs
LBSTAT
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Subject Identifiers (USUBJID & SUBJID)
• ‘Subject’ should be used where applicable – consistent with the recommendation in FDA guidance – generically refers to both patients and healthy volunteers.
• USUBJID – Unique Subject Identifier across all studies – must be unique for each trial participant (subject) across all
trials in the submission. – no two (or more) subjects, across all trials in the submission,
may have the same USUBJID. – the same person who participates in multiple clinical trials
(when this is known) must be assigned the same USUBJID value in all trials.
• SUBJID – Subject Identifier for the Study
USUBJID SUBJID
Uniquely identifies a subject across trials
Uniquely identifies a subject within a trial
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Sequence Variable (--SEQ)
• The Sequence Number (--SEQ) – uniquely identifies a record for a given USUBJID within a domain. – required in all domains (except DM) – Conventions for values are sponsor-defined. – Values may or may not be sequential depending on data
processes and sources. – Necessary to link observations between domains such as
• Linking parent and supplemental qualifier observations • Relating records together (RELREC, CO)
Subject 1234 6 conmeds
Sequential number 1 thru 6, uniquely identifying each observation for that USUBJID
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Relationships and Linking
• --GRPID
Relationships within a domain
• RELREC • CO
Relationships across domains
• SUPP
Non-standard questions
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Relationships and Linking: --GRPID
Subject 1234 6 conmeds
CMGRPID represents a relationship between observations. CMSEQ = 1, 2, 3 are related (Combination Therapy 1) CMSEQ = 4, 5, 6 are related (Combination Therapy 2)
Relationships within a domain
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Relationships and Linking: RELREC
Related Adverse Event & Disposition Event
RELID indicates the relationship identifier
IDVAR & IDVARVAL represents the observations that are related
RDOMAIN represents the related domains
Relationships across
domains
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Relationships and Linking: CO
RDOMAIN represents the related domains
IDVAR & IDVARVAL represents the observations that are related
Relationships across
domains
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Relationships and Linking: SUPPs
LB Family
Parent Child
Parent = LB
Child = SUPPLB Link via LBSEQ
Relationship to non
standard questions
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Controlled Terminology
• Certain variables are ‘controlled terms’ • Values from a pre-defined list
• Represented 1 of 4 ways in the IG
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Date Formats
• Dates in SDTM represented in ISO8601 format
• Dates in SDTM are character, enabling partial dates ISO8601 format
YYYY-MM-DDThh:mm:ss
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Reference Start Date (RFSTDTC)
• Subject Reference Start Date (RFSTDTC) – designated as Study Day 1 – usually relates to the day subject was first exposed to study drug – the date preceding designated as Study Day -1 – there is no Study Day 0
RFSTDTC
Day -n Day -2 Day -1 Day 1 Day 2 Day n … …
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Study Day (--STDY)
• sequential days relative to a reference point • all Study Day values are integers.
• Calculate Study Day: – if --DTC is on or after RFSTDTC
• --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 – if --DTC precedes RFSTDTC
• --DY = (date portion of --DTC) - (date portion of RFSTDTC)
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Study Day (--STDY)
RFSTDTC
13OCT2013 15OCT2013 14OCT2013 16OCT2013
Day -1 Day 2 Day 1 Day 3
No Study Day 0!!
17OCT2013
Day -2
-1 +1
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Handling Text
• Casing – Upper case (recommended) – Exceptions include
• Comments / Free text • --TEST in Findings domains • External dictionary text (e.g. MedDRA) • Unit symbols (e.g. mg/dL)
• Free Text – General Comments – ‘Specify’ values for
• Result qualifier variables • Non-result qualifier variables • Topic variables
Free text collected on a dedicated CRF page and/or related to one or more SDTM domains will be stored within the CO (Comments) domain
Free text responses to specific questions
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Handling Specify Text
• Result qualifier variables • Non-result qualifier variables
• Topic variables
Remember – the limit for all variables in SDTM is
$200
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Original & Standard Results
• --ORRES – original result in a Findings domain (e.g. LB) – Expected Variable should be populated – With exception of
1. –STAT = ‘NOT DONE’ (Status variable) 2. -DRVFL = ‘Y’ (Result is derived)
• When --ORRES is populated 1. --STRESC (std character result) must be populated 2. --STRESN (std numeric result) should be populated when result is
numeric
• --STRESC is derived by conversion of values in --ORRES to values with standard units
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Missing Values
• Missing values should be represented by nulls. – Note: This is a change from previous versions of the SDTMIG
which previously allowed sponsors to define their conventions for missing values.
• When groups of tests are not performed
• Individual missing –TESTCD, will have --STAT = NOT DONE
Variable Value Example --TESTCD --ALL LBALL -- TEST Name of module Labs Data --CAT Name of group of tests Urinalysis --ORRES Null --STAT NOT DONE NOT DONE --REASND If collected Not collected
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Multiple Values
Type Example Action Result Intervention Topic variable
TYLENOL AND BENADRYL
Split CMTRT = TYLENOL CMTRT = BENADRYL
Event Topic variable
HEADACHE AND NAUSEA
Split AETERM = HEADACHE AETERM = NAUSEA
Findings Result variable
ATRIAL FIBRILLATION AND ATRIAL FLUTTER
Split EGORRES= ATRIAL FIBRILLATION EGORRES = ATRIL FLUTTER
Non Result Qualifier
AE LOCATION check all that apply
MULITPLE with SUPP
AELOC = MUTIPLE SUPPAE.QNAM = AELOC1, 2,…n
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Timing & Timepoint Variables
• --STRF – used to identify the start of an observation relative to
the sponsor-defined reference period. • --ENRF
– used to identify the end of an observation relative to the sponsor-defined reference period.
• Reference period: RFSTDTC to RFENDTC
• Values: BEFORE, DURING, AFTER, DURING/AFTER, U (for unknown)
RFSTDTC RFENDTC
BEFORE DURING
DURING/AFTER
AFTER
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Timing & Timepoint Variables
• When to use --STRF and –ENRF?
1. When CRF collect the below type of information in lieu of a date
2. Some sponsors may wish to derive --STRF and --ENRF for analysis or reporting purposes even when dates are collected.
*Sponsors are cautioned not to use –STRF & --ENRF for both (1) and (2), as it will blur the distinction between collected and derived
values within the domain.
**Sponsors wishing to derive for reporting purposes are instead encouraged to use supplemental variables or analysis datasets for
this derived data
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Timing & Timepoint Variables
• Represent timing information relative to a specific time point --STRTPT (Start Reference Time Point) --STTPT (Start Time point) --ENRTPT (End Reference Time Point) --ENTPT (End Time point)
--STTPT BEFORE COINCIDENT
AFTER
e.g. Date of withdrawal
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Timing & Timepoint Variables
REFERENCE VARIABLE
START END VALUES
--STRF RFSTDTC RFENDTC BEFORE, DURING, DURING/AFTER, AFTER, U
--ENRF RFSTDTC RFENDTC BEFORE, DURING, DURING/AFTER, AFTER, U
--STRTPT --STTPT BEFORE, COINCIDENT, AFTER, U
--ENRTPT --ENTPT BEFORE, COINCIDENT, AFTER, ONGOING, U
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Splitting Domains
• Why split domains? – Size restrictions: exceeds limitations – Ease of use: store topically related observations together
• Considerations when splitting domains – Split by category (--CAT) e.g. LBCAT = HEMATOLOGY,
CHEMISTRY – Split dataset names can be up to four characters in length e.g LBHM,
LBCH – Value of the DOMAIN variable consistent across the separate
datasets e.g. DOMAIN = ‘LB’ in all – Variables have the same attributes across the split domains – Permissible variables included in one split dataset need not be
included in all split datasets. – --SEQ must be unique within USUBJID for all records across all the
split datasets, and relate in the same way to SUPPs, CO, RELREC
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Splitting Domains
In short, if you append the split domains together, they should have the same appearance and work in the same way like
you have never split them!
Study 1
Study 2
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What we covered
• Naming Conventions • Subject Identifiers
• Sequence Variable
• Relationships and Linking • Controlled Terminology
• Dates Formats • Reference Start Date & Study Days
• Handling Text
• Original & Standard Results • Missing & Multiple Values
• Timing and Timepoints • Splitting Domains
An Introduction to SDTM – Part II
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An Introduction to SDTM – Part II