FDA scripts. Programming and validation of script/programs.

1. FDA: WG5. Working group FDA scripts.Programming and validation of script/programs. Heavy and light validation Check list FDA scripts Basis for discussion FDA: WG5. Working group

2. 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.

3. FDA: WG5. Working group Heavy validation: Establish min. SDTM/ADaM test data Specification Documentation or document in header GPP. God Programming Practise Usertest Standardprogram (Beta) 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 Create Validation report Peer review Peer review Test final Standard program for CDISC Compliance Submit to FDA as script

4. FDA: WG5. Working group Light validation 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.