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    Cdisc Syllabus

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    Abhinav Tangella
    This document provides an overview of topics related to clinical SAS including an introduction to SDTM and ADaM data standards, the roles of clinical research forms, SAS programmer responsibilities, and how to generate summary reports, listings, and graphs from clinical trial data including demographics, adverse events, vital signs, laboratories, and figures for concentration over time and means. It covers 37 topics ranging from clinical SAS terminology to producing tables, listings, and figures from SDTM and ADaM datasets for inclusion in clinical study reports.

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    Download as PDF, TXT or read online from Scribd

    Cdisc Syllabus

    Uploaded by

    Abhinav Tangella
    182 views2 pages
    This document provides an overview of topics related to clinical SAS including an introduction to SDTM and ADaM data standards, the roles of clinical research forms, SAS programmer responsibilities, and how to generate summary reports, listings, and graphs from clinical trial data including demographics, adverse events, vital signs, laboratories, and figures for concentration over time and means. It covers 37 topics ranging from clinical SAS terminology to producing tables, listings, and figures from SDTM and ADaM datasets for inclusion in clinical study reports.

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    Cdisc syllabus

    Original Title

    CDISC SYLLABUS

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    This document provides an overview of topics related to clinical SAS including an introduction to SDTM and ADaM data standards, the roles of clinical research forms, SAS programmer responsibilities, and how to generate summary reports, listings, and graphs from clinical trial data including demographics, adverse events, vital signs, laboratories, and figures for concentration over time and means. It covers 37 topics ranging from clinical SAS terminology to producing tables, listings, and figures from SDTM and ADaM datasets for inclusion in clinical study reports.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    182 views2 pages

    Cdisc Syllabus

    Uploaded by

    Abhinav Tangella
    This document provides an overview of topics related to clinical SAS including an introduction to SDTM and ADaM data standards, the roles of clinical research forms, SAS programmer responsibilities, and how to generate summary reports, listings, and graphs from clinical trial data including demographics, adverse events, vital signs, laboratories, and figures for concentration over time and means. It covers 37 topics ranging from clinical SAS terminology to producing tables, listings, and figures from SDTM and ADaM datasets for inclusion in clinical study reports.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    S.

    NO CDISC
    1 Introduction to Clinical SAS
    2 Clinical SAS Terminology
    3 Protocol explanation
    4 Role of CRF
    5 General documents required for clinical SAS programming
    6 Clinical SAS Programmer Roles and Responsibilities
    7 SDTM – Introduction
    8 SDTM – Domains
    9 SDTM – DM
    10 SDTM – Interventions
    11 SDTM – Events
    12 SDTM – Findings
    13 SDTM – Other
    14 SDTM – Define.xml
    15 Introduction to ADaM
    16 Key Concepts
    17 ADaM naming conventions
    18 ADaM Implementation
    19 Fundamentals of the ADaM Standards
    20 Variables in General
    21 ADSL variables
    22 BDS Variables
    23 ADSL
    24 ADAE
    25 ADVS
    26 ADMH
    27 ADLB
    28 TLFs
    29 Introduction to Clinical Trail
    30 Summary Reports (Tables Listings and Figg)
    31 Protocol
    32 crf/ecrf
    33 SAP
    34 Mock Shells
    35 Introduction about the statistical reports
    36 SAS programs development, and validation (QC)
    37 Generating Summary Reports
    38 Demog summary report
    39 Adverse event report
    40 Vital signs report
    41 Lab summary report
    42 shift table
    43 Generating Listings
    44 Demog listing
    45 Advesre event listing
    46 vital listing
    47 Generating Graphs
    48 concentration vs time figures
    49 mean +sd related figures

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