Standard Scripts Proposal through CSS 2014 http wwwphusewikiorgwikiindexphptitleFileFDAScripsppt Anyone should be able to submit a script according to a check list Categorize scripts according to complexity ID: 778803
Download The PPT/PDF document "WG5 P02 Proposal 2014 Qualification of" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
WG5 P02 Proposal
2014Qualification of Standard Scripts
Slide2Proposal through CSS 2014http://www.phusewiki.org/wiki/index.php?title=File:FDA_Scrips.pptAnyone should be able to submit a script, according to a check list
Categorize scripts according to complexityComplexity: low, medium, high, softwareOutput: tabulated data, analysis data, table, figure, listingMetadata for script should indicateType of output: tabulated data, analysis data, table, figure, listingStudy design: parallel, crossover, etcState of qualification
Slide3Proposal through CSS 2104Test dataOverall project should have minimum test data (SDTM & ADaM)Scripts can propose new test data, must pass (Data fit? Open CDISC?)2 levels of qualification to match script complexity/output
Light vs. Heavy qualificationCommon elements includeheadergood programming practicesclearly declared scope of script (e.g., study design(s))test data matches scope & passes "FDA Data Fit" assessment (?)documentation inputs/outputs/dependencies/usage
Slide4Proposal through CSS 2104Heavy qualificationBeta package includes minimal elements for contributionSpecification & Documentation (could be in pgm header)Test data (Data Fit? or Open CDISC or other, as appropriate)
Tests & Expected results definedPeer Review: GPP, Specs & Docn reviewed, Tests reproducedDraftWrite qualification plan, Review tests for completeness/suitability (e.g., Branch testing – are all conditional blocks/combos tested?)TestPeer Review: Write qualification report, incl. log/output from testsFinal
Slide5Proposal through CSS 2104Light qualificationBeta package includes skip if >1 yr production use without ERRORDraft
minimal elements for contributionSpecification & Documentation (could be in pgm header)Test data (Data Fit? or Open CDISC or other, as appropriate)Tests & Expected results definedPeer Review: GPP, Specs & Docn reviewed, Tests reproducedWrite qualification plan, Review tests for completeness/suitability (e.g., Branch testing – are all conditional blocks/combos tested?)TestPeer Review: Write qualification report, incl. log/output from testsFinal
Slide6Proposal through CSS 2104Peer Review Checklist
HeavyLightRequirement specificationX?Documented or perhaps only documented in headerXUser GuideXXSDTM/ADaM used in input/outputXXOpen CDISC validator or Data Fit used to check input/outputXXGPP in sourceXXRun according to Requirement specificationX
?Tested by qualification plan, tests & results all Peer reviewedX?Tested by End usersX?Robust without red errors in contributor's production environmentXXRobust and used in FDA (other) scripts repository, ranked ******X
Slide7Proposal meaningful terms in blueQualification
Certification applies to new scripts and testsConfirmation applies to updates of existing scriptsStates: Contributed, Development, Testing, QualifiedRolesContributor: Anyone with appropriate skills & interestsDeveloper: CSS Working Group 5 volunteer** familiar with objectivesTester: CSS WG 05 volunteer**Environment Tester: Anyone in industry community able to set up automatic test replication in their work environmentReviewer: Author of white papers, designers of script targets** suggests an quick-start onboarding page in CSS Phusewiki
Slide8ProposalQualificationTransitions Contributed is the original State of all scriptsto Development checklist includes by
Developer & ReviewerD reviews componentsD works with Contributor to complete minimum components[ including Test Data and Coverage of defined tests ]R confirms contributed output matches/approximates target[ may require analysis details, specs, from contributor ]D writes Qualification instructions .docx (see template)to Testing by TesterReview Qualification instructions, consider coverage of testsExecute Qualification instructionsWork with Developer to complete execution successfully
Slide9ProposalQualificationTransitions continuedto Qualified by T
ester & Environment TesterT updates posted test outputs from certification/confirmationE updates local tests and executes (posting PASS/FAIL results)Achieve "Qualified" state when all tests in all test environments PASS (i.e., match outputs that T has certified and/or confirmed
Slide10ProposalQualificationEfforts RequiredReview proposal within WG05Finalize Qualification states, roles, workflow and templates
Design test structure in google codeDevelop scripts that will allow Environment TestingIdentify Environment Testers based onHost environmentSAS or R versionIdentify opportunities to automate qualification. E.g.,Docx format for Qualification instructions is not easily machine readableEnvironment Testers to post results back as machine readableScript green-light/red-light qualification matrix on Phusewiki
Slide11Doing now what patients need next