FDA scripts. Validation of script/programs. Heavy and light validation Check list FDA scripts Basis for discussion FDA: WG5 Project 02 18/8/2015 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. 208/08/2015

Heavy validation: 38/8/2015 Specific ation Standard program (Beta) Documentat ion or document in header User test Standard program Draft Establish min. SDTM/ADaM test data GPP. God Program ming 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 Create Validation report Submit to FDA as script Test final Standard program for 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 48/8/2015 Existing Standard program Draft Test for CDISC Compliance Submit to FDA 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..) xx User Guide exist xx Has program Data Fit been used (FDA program for data model check) xx 508/08/2015 Check list FDA scriptHeavyLight Robust without red errors in companies’ production environment. xx Robust and used in FDA scripts repository, ranked ******. x Open CDISC validator or Data Fit used to check input/output. xx SDTM/ADaM used in input/output. xx GPP in source. xx Documented or perhaps only documented in header. x User Guide. xx Requirement specification. x? Run according to Requirement specification. x? Tested by validation plan, test program all Peer reviewed x? Tested by Endusers x?

WG5 Project /08/2015 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:

1. A BOARD that meets 4 times a year and decide whether a script can be called validated and move it from folder to 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 to folder. A Naming convention could be an advantage E.g. Prefix: Not validated scripts: (nothing) Validated scripts: _production WG5 Project /08/2015 The process to move the scrip could be: