FDA scripts. Validation of script/programs.

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FDA scripts.Validation of script/programs.
WG5 Project 02

• Heavy and light validation
• Check list FDA scripts
• Basis for discussion
• FDA WG5 Project 02

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• Programming and validation of script/programs.
•  
• I image that everyone can submit a script to FDA.
• They just have to fill in the check list and use
  Data Fit - FDA product(check for CDISC) !!, but
  it is important that FDA is safe with the process
  we find.
•  
• Things to consider
• Script must be divided in small, medium, large
  and software
• Script must be divided in to produce derived
  data, (SDTM or ADaM).
• to
  produce TFL.
• Script validations type Heavy validation
  Light validation
• --------------------------------------------------
  ------------------------------------------
• Test data SDTM description of
  version (should FDA have there own
  repository) . Establish min. SDTM/ADaM
  test data. Requirement for minimum data to
  test script
• Check test data Check for CDISC.
  Use Software Data Fit.?
• Should
  all contributors use Data Fit before they submit
  a standard script. Data Fit checks data
  model, but not necessary a standard script
  connections to data model.
• Or should
  a standard script be developed that check for
  SDTM/ADaM.
• Study design A script must run on
  all kinds of designs(parallel, crossover
  etc.) It could also just be stated in
  specification which design is applicable.
• Parameter to a script How to describe. Should
  it be a small dataset holding all parameters.
• Template We must have a
  template for program header. Coordinate GPP
  group.

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Heavy validation
WG5 Project 02
Establish min. SDTM/ADaM test data
Specification
Documentation or document in header
GPP. God Programming Practise
Standard program (Beta)
User test
Peer review
Use of Data Fit ?
Standard program Draft
Plan
Report
Use of Data Fit ?
Create validation plan, test program and Test
data(STDM/ADaM).
Branch test (test all If statements in source
Test Output from all test cases
Test log from all test cases
Peer review
Create Validation report
Peer review
Test final Standard program for CDISC Compliance
Submit to FDA as script
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Light validation
WG5 Project 02
Existing Standard program Draft
Note Must be GPP in Source. Must use
SDTM/ADaM data/test data Must be
documented Must be tested by End Users
Must be a user Guide
1-2 years of production without ERROR
Establish min. SDTM/ADaM test data
Use Data Fit (FDA program) !
Test for CDISC Compliance
Note Must use SDTM/ADaM in input and output.
Submit to FDA as script
Note Use Check List.
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Check list FDA script Heavy Light
Robust without red errors in companies production environment. x x
Robust and used in FDA scripts repository, ranked . x
Open CDISC validator or Data Fit used to check input/output. x x
SDTM/ADaM used in input/output. x x
GPP in source. x x
Documented or perhaps only documented in header. x
User Guide. x x
Requirement specification. x ?
Run according to Requirement specification. x ?
Tested by validation plan, test program all Peer reviewed x ?
Tested by Endusers x ?





Able to run on all Trial design(parallel, crossover, extension..) x x
User Guide exist x x
Has program Data Fit been used (FDA program for data model check) x x
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WG5 Project 02
Moving a script to production Use folder
./src for non validated scripts Use folder
./valid for validated scrips. Discuss by whom
and how Goggle Code Repository
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WG5 Project 02
The process to move the scrip could be

• 1. A BOARD that meets 4 times a year and decide
  whether a script can be called validated and
  move it from folder lt.srcgt to lt.validgt folder.
• 2. Establish the checklist electronic. Committers
  must tick mark witch items on the list the script
  fulfil and are then allowed to move a script from
  folder lt.srcgt to lt.validgt folder.
• A Naming convention could be an advantage
• E.g. Prefix
• Not validated scripts (nothing)
• Validated scripts _production