Sdtm validation
This presentation is the property of its rightful owner.
Sponsored Links
1 / 9

SDTM Validation PowerPoint PPT Presentation


  • 73 Views
  • Uploaded on
  • Presentation posted in: General

SDTM Validation. Delaware Valley CDISC user network Ketan Durve Johnson and Johnson Pharmaceutical Reasearch and Development May 11 th 2009. Context and Scope. Safety and study population SDTM data and metadata for 2 FDA submissions, mapped from legacy sponsor standards

Download Presentation

SDTM Validation

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Sdtm validation

SDTM Validation

Delaware Valley CDISC user network

Ketan Durve

Johnson and Johnson

Pharmaceutical Reasearch and Development

May 11th 2009


Context and scope

Context and Scope

  • Safety and study population SDTM data and metadata for 2 FDA submissions, mapped from legacy sponsor standards

  • Tweaked for acceptance checks in data transfers from data management to programming

Johnson and Johnson Pharmaceutical Research and Development


Tools and processes

Tools and Processes

  • Programmatic and non-programmatic checks

  • Programmatic data and metadata checks executed using SAS

  • FDA / WebSDM based checks as well as sponsor defined checks

  • Data in SAS v8 datasets and metadata in an oracle database metadata repository

  • Custom IG with default Origin, Length, Comment / Computational Method based on sponsor standards

Johnson and Johnson Pharmaceutical Research and Development


Metadata repository

Metadata Repository

  • Tables and relationships for datasets, variables, codelists and valuelists

  • Study metadata as well as a customized IG

  • Metadata source for Define.Xml

  • SAS Views provide access to metadata for SDTM validation

  • Minimal checks when loading metadata as SAS datasets or Excel spreadsheets

  • Provides attribute file for checking and creation of permanent SDTM SAS datasets

Johnson and Johnson Pharmaceutical Research and Development


Study metadata vs ig metadata

Study Metadata Vs IG Metadata

  • Variables match those in IG or are acceptable optional variables

  • Label, role, core, order and length match IG

  • Data Type, significant digits, origin, comment and computational method match IG or are appropriate study specific modifications

  • Account for extensions of the general observation classes

Johnson and Johnson Pharmaceutical Research and Development


Metadata checks

Metadata Checks

  • Consistency across dataset, variable, value level and codelist metadata

  • If variable has value level metadata or controlled terminology specified, then appropriate codelists and valuelists are defined in study metadata

  • Existence of value level metadata for –TESTCD and QNAM

  • Codelists defined with beginning and ending values or dictionary and version

Johnson and Johnson Pharmaceutical Research and Development


Data checks

Data Checks

  • Amended version of WebSDM IR4100 - IR4140 within domain data validity checks, with additional variables included and updates for

    • --STRF/--ENRF or --STDTC/--ENTC null when --OCCUR is N

    • --ORRES and --STAT both null when --DRVFL is Y

    • Null values in --ORRESU for titers and sample status

    • Null values for --STDTC when --ENDTC is valued for prior onset records

  • Cross domain data checks for presence of records for subjects in DM, EX and DS if found in any other domain who are not screen failures

Johnson and Johnson Pharmaceutical Research and Development


Data vs metadata checks

Data Vs Metadata Checks

  • No missing values for required variables

  • Check data type and origin are valid values

  • Significant digits populated when data type is float and reflect precision

  • SAS dataset and variable attributes for label, type and length as well as variable order match metadata

  • All variables in Metadata exist in dataset and no extraneous variables exist in dataset

  • If controlled terminology associated with variable, then values match valid values per codelists and valuelists

Johnson and Johnson Pharmaceutical Research and Development


Questions

Questions?

Johnson and Johnson Pharmaceutical Research and Development


  • Login