CLINICAL SAS

SAS Clinical Project Content (CDISC SDTM ADaM TLF)

Therapeutic Area: Diabetic

Duration: 50 Hour

Part 1

a.      Introduction about the course

b.      Introduction about the each deportments(clinical operations, CDM, Bio-statistics and  Medical writing)

c.       Detailed information about the Bio-Statistics (statistician, statistical programmers and SAS programmers)

d.      Introduction about the Client, Regulatory bodies  ,Submission of the study

e.    Introduction to specifications 

Part 2:  CDISC -SDTM

Introduction of CDISC
b.      Why CDISC and DATA standards

c.       What are the versions of CDISC

d.      Impact of CDISC Standards on Clinical Acitivities

e.      CDISC Models

f.        Study Data Tabulation Model (SDTM)

g.      Analysis Dataset Models (ADaM)

h.      Operational Data Model (ODM)

Fundamentals of SDTM

a.      What is SDTM?

b.      Observations and Variables in SDTM

c.       Special Purpose Datasets

d.      General Observation Classes in SDTM

e.      SDTM Standard Domain Models

f.        Creating New Domain

Submitting Data in Standard Format

a.      Assumptions for Domain Models

b.      General Assumptions for all Domains

Models for Special Purpose Domains

a.      DM, CO, SE and SV

Domain Models Based on the General Observation Classes

      1. Interventions

a.      CM, EX , SU, EC

       2.Events

a.      AE, DS, MH, DV, HO

                   3. Findings

a.      LB, EG, VS, PE, IE, DD, QS etc..

                   4. Trial Design Domains

a.      TA, TE, TS, TI and TV

                 5.   REL REC

6.   Supplemental Qualifies

1.         SUPPDM
2.        SUPPAE
3.         SUPPMH
4.          SUPPPE
5.        SUPPAE

SDTM Mapping Programming Using SAS

SDTM Annotation on CRF

SDTM Mapping Specifications

Real time Project on SDTM

              Define.xmL

Part 3:  CDISC -ADaM:

a.      Introduction to ADaM

b.      Why ADaM

c.       Key Concepts

d.      ADaM naming conventions

e.      ADaM  Implementation

f.        Fundamentals of the ADaM Standards

g.      Variables in General

h.      ADSL variables

i.        BDS Variables

j.        Real time Project on ADAM

k.       ADAE

l.         ADLB

m.     ADMH

n.       ADDS

o.      ADVS

p.       ADEX

Part 4: TLFs

a.      Introduction to Clinical Trail

b.      Summary Reports (Tabels Listings and Figg)

c.       Introduction  about the ICH E6,E9 and E3

d.      Protocol

e.      CRF/eCRF

f.        SAP

g.      Mock shells

h.      Introduction about the statistical reports

i.        Introduction about the clinical study report

j.        SAS programs  development,  and validation (QC)

k.       MeDRA Guidelines

l.        Generating Summary Reports

m.    Generating Listings

n.      Generating Graphs

o.      Real time Project on  Phase II Clinical Trial Studies (Diabetics therapeutic area)