CDISC STANDARDISATION & TRAINING


Training courses are currently available for:

LSAF Training Offering
Is LSAF new for you and would you like to get familiar with the interface of LSAF and learn how to manage content in the repository and workspace? Or are you a LSAF user, but would you like to get more out of your LSAF system as a programmer by for instance setting up more advanced jobs or as administrator in managing privileges, roles and permissions in a more efficient way, then we can help you! OCS Life Sciences offers off-the shelf training suitable for Data Managers, SAS Programmers and/or Administrators, but also develops bespoke training tailored to your needs.

Statistics for Programmers
Out Biostatisticians developed a training for SAS programmers to learn:
  • Common basic statistical terms used in clinical trials data analysis- Analysing 2*2 and n*p categories
  • Testing normality of the data
  • How to calculate basic statistics using SAS
  • Introduction to different t-tests
  • Correlation and regression analysis
This training is suitable for any SAS programmer who wants to learn basic statistics and how to use it on a regular basis.

PK and PD Basics
Have you heard the terms pharmacokinetics (PK) and pharmacodynamics (PD) and wonder what that is all about?
In this training we will look at:
  • the definitions of PK and PD
  • the course of action of medication through your body
  • the role of PK in clinical research
  • the basic PK parameters and how to calculate it
  • we will zoom in on bio-equivalence studies and how to analyse it
This training is suitable for anybody who are curious to know the basics of PK and you do not require any prior knowledge of this topic.

Fundamentals of Clinical Trials
An introduction to the fundamentals of clinical trials, including (but not limited to):
  • Drug development
  • Trial design
  • Important documents
  • Data management
  • Statistical programming
  • Statistical analysis
  • Guidelines
CDISC SDTM
An introduction to CDISC SDTM data standards and related topics, including (but not limited to):
  • CDISC overview including CDASH
  • CRF annotation
  • SDTM fundamentals and domains
  • From source to SDTM: step-by-step
CDISC ADaM
An introduction to CDISC ADaM data standards and related topics:
  • Introduction to ADaM
  • ADaM basics and general conventions
  • Fundamentals and purpose of the main ADaM data structures
CDISC Define-XML + S/ADRG
An introduction to CDISC Define-XML (CRT-DDS) and the Study/Analysis Reviewers Guide, including:
  • Introduction to XML
  • Define-XML for SDTM and ADaM
  • Generating and validating Define-XML
  • Walkthrough for SDRG and ADRG
Programming
An in-depth and hands-on training in SAS programming using SAS Studio including (but not limited to):
  • Reading data from various sources
  • Data mapping and conversion:
         - SDTM and ADaM specific derivations (baseline flag, treatment flags, missing data imputation, double or triplicate        measurements, unit conversion, length limitation)
  • Edit checks and consistency checks
  • Producing output:
          - Tables, Listings, Figures
          - Output formats and templates
          - Basis statistical procedures
  • Advanced programming techniques
Validation Essentials
An introduction and hands-on training in the basic concepts of validation, including (but not limited to):
  • Development, Validation, Production
  • Peer review and double programming
  • Title 21 CFR Part 11
We can also develop a bespoke training tailored to your needs.