Clinical SAS Project Training for Beginners👌| CDISC SDTM ADAM TLF'S Training Complete Project Flow 👍
Clinical SAS Project Training for Beginners CDISC SDTM ADAM TLF'S Training Complete Project Flow
CDISC (SDTM, ADAM, TLF'S)
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Sponsor
Protocol Team
Protocol
CRF Team
CRF
Site Management Team
Subjects
Data Collection
Clinical Data Management Team
Raw Study data (Excel,CSV,database,SAS Dataset.)
Data Analysis Team
Biostatistician & SAS Programmers
-- SAP
Medical Writing Team
-- CSR
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Clinical Trail Study Data -- CDISC Organization Developed Standards (SDTM)
- (ADAM) Analysis Datasets- Regulatory
Industry Workflow
SDTM Standards
SAP Document
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Study Start
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Protocol
Case Report Form (CSR)
Raw Datasets
SAP
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Create aCRF (Validated by Team Lead)
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SDTM Mapping Specifications Excel
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Programming Plan
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SAS Programming (SAS Software)
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SDTM,ADaM Standards Datasets
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Create XPT Files
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Pinnacle21
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Define.Xml
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Submit Study
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SDTM Guidelines:
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SDTM (Study Data Tabulation Model)
Data that we have collected during the study to be stored with proper integrity and
as per the Standards
Versions:
3.1
3.2 -- Most Popular
3.3
3.4
As per SDTM each domain name should be 2chars long only (Abbreviation)
EX: Adverse Events (AE)
Demographics (DM)
Substance Use (SU)
Every domain should have proper labels up to 40chars (Prop Case)
Variable names should not exceed 8 Chars (CAPS) long
EX: USUBJID
RFSTDTC
Variable order should be as per SDTM IG
All dates in SDTM will be stored as CHARACTER Datatype variables
All date/Time should store ISO 8601
AM/PM not allowed in SDTM IG
YYYY-MM-DD
YYYY-MM-DDTHH:MM: SS
-(hyphen) -- To separate 'Year' from 'month' from 'day'
To represent missing date component
:(colon) To separate 'Hours' from 'minute' from 'sec'
/ -- To separate date and time intervals
P(Period) -- To represent duration
Date/Time Recorded values
Missing date/time components
Intervals
Duration
Variable Name
Variable Label
Type
Controlled Terms, Format
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Role
CDISC Notes
Assigned
Derived
Recorded
EX: USUBJID (concatenating STUDYID-SITEID-SUBJID.)
Core
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This can be categorized into 3 types
1.REQ (Required)
These variables must be included in the domain/dataset
These variables cannot have Null(missing) values
EX: SUBJID, USUBJID
2.EXP (Expected)
These variables must be included in the domain/dataset
Missing Values are Allowed
EX: DTHDTC
3.PERM(Permissible)
These variables are depending on study/sponsor
If sponsor decided/collected data then include, Ele, we can skip them
Missing values are Allowed
EX: INVID
INVNAM
Role:
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SDTM IG defined role for each variable for all the domains
Identifier Variables
Topic Variables
Timing Variables
Rule Variables
Qualifier Variables
Record Qualifier
Result Qualifier
Grouping Qualifier
Synonym Qualifier
Variable Qualifier
Identifier Variables
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These variables give identification information
One domain can have one or more Identifier Variables
Ex: SUBJID
Topic Variables
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Topic variables focus on the entire meaning of the dataset
Every domain can contain only one topic variable
Ex: DM(SUBJID)
Timing Variables:
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Describes the timing of an observation
Ex: STDTC (start Date)
Rule Variables
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This variable provides start rule and end rule information
Ex: TV -- TVSTRL and TVENRL
Qualifier Variables
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Record Qualifier
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Recording or getting or taking measurement
Ex: BRTHDTC
AGE
Result Qualifier
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these variable contains results
Ex:
LBORRES
VSOR
Grouping Qualifier
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Group the set of observations together based on category
EX: --CAT
--SCAT
Synonym Qualifier
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Similar meaning variables
Ex:
----
ELEMENT - SCR
ETCD - SCREEING
AETERM - FEVER
AEDECOD- PYROXIA
Variable Qualifier
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These can be used to describe the value of an observation
Variables with units
EX: DOSEU
SDTM #ADAM #TLF'S Training
