Clinical SAS Project Training for Beginners👌| CDISC SDTM ADAM TLF'S Training Complete Project Flow 👍 скачать в хорошем качестве

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) What is Clinical SAS Programming Means? What is CDISC SDTM,ADaM,TLF'S? SAS programmer Work Description in clinical industry. what is a Clinical trial process? The Drug Development Process. Drug Approval Process Teams are involved in end-to-end process of a clinical trail ------ 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 -- Clinical Trail Study Data -- CDISC Organization Developed Standards (SDTM) - (ADAM) Analysis Datasets- Regulatory Industry Workflow SDTM Standards SAP Document ------------- Study Start | Protocol Case Report Form (CSR) Raw Datasets SAP | Create aCRF (Validated by Team Lead) | SDTM Mapping Specifications Excel | Programming Plan | SAS Programming (SAS Software) | SDTM,ADaM Standards Datasets | Create XPT Files | Pinnacle21 | Define.Xml | Submit Study -------------- SDTM Guidelines: ----------- 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 --------- Role CDISC Notes Assigned Derived Recorded EX: USUBJID (concatenating STUDYID-SITEID-SUBJID.) Core ----- 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: ----- 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 ----- These variables give identification information One domain can have one or more Identifier Variables Ex: SUBJID Topic Variables ------ Topic variables focus on the entire meaning of the dataset Every domain can contain only one topic variable Ex: DM(SUBJID) Timing Variables: ----- Describes the timing of an observation Ex: STDTC (start Date) Rule Variables ----- This variable provides start rule and end rule information Ex: TV -- TVSTRL and TVENRL Qualifier Variables ----- Record Qualifier ------- Recording or getting or taking measurement Ex: BRTHDTC AGE Result Qualifier ------- these variable contains results Ex: LBORRES VSOR Grouping Qualifier ------- Group the set of observations together based on category EX: --CAT --SCAT Synonym Qualifier ----- Similar meaning variables Ex: ---- ELEMENT - SCR ETCD - SCREEING AETERM - FEVER AEDECOD- PYROXIA Variable Qualifier ---- These can be used to describe the value of an observation Variables with units EX: DOSEU SDTM #ADAM #TLF'S Training