fda scripts. validation of script/programs. heavy and light validation check list fda scripts basis...

FDA scripts.

Validation of script/programs.

Heavy and light validationCheck list FDA scripts

Basis for discussionFDA: WG5 Project 02

104/19/23

WG5 Project 02

• 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.

219/04/23

Heavy validation:

304/19/23

Specification

Standard program (Beta)

Documentation or document in header

User test

Standard program Draft

Establish min. SDTM/ADaM test data

GPP. God Programming Practise

Create validation plan, test program and Test data(STDM/ADaM).

Use of Data Fit ?

Branch test (test all If statements in source

Peer review

Peer review

Create Validation report

Submit toFDA as script

Test final Standard programfor CDISC Compliance

Test Output from all test cases

Test log from all test cases

Peer review

Plan Report

WG5 Project 02

Use of Data Fit ?

Light validation

404/19/23

Existing Standard program Draft

Testfor CDISC Compliance

Submit toFDA as script

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

Note: Must use SDTM/ADaM in input and output.

WG5 Project 02

Use Data Fit (FDA program) !

Establish min. SDTM/ADaM test data

Note: Use Check List.

Able to run on all Trial design(parallel, crossover, extension..) x xUser Guide exist x xHas program Data Fit been used (FDA program for data model check) x x

519/04/23Check list FDA script Heavy Light

Robust without red errors in companies’ production environment. x x

Robust and used in FDA scripts repository, ranked ******. xOpen CDISC validator or Data Fit used to check input/output. x xSDTM/ADaM used in input/output. x xGPP in source. x xDocumented or perhaps only documented in header. xUser Guide. x xRequirement specification. x ?Run according to Requirement specification. x ?Tested by validation plan, test program all Peer reviewed x ?Tested by Endusers x ?

WG5 Project 02

619/04/23

Moving a script to “production”:Use folder ./src for non validated scriptsUse folder ./valid for validated scrips.

Discuss by whom and howGoggle Code Repository:

• 1. A BOARD that meets 4 times a year and decide whether a script can be called validated and move it from folder <.src> to <.valid> 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 <.src> to <.valid> folder.

A Naming convention could be an advantageE.g. Prefix: Not validated scripts: (nothing)Validated scripts: _production

WG5 Project 02

719/04/23

The process to move the scrip could be: