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Trial Summary Domain from IG 3.1.2 to 3.1.3

Trial Summary Domain from IG 3.1.2 to 3.1.3. Dieter Boß September 2012. Purpose of Trial Summary Domain. Submit summary of study in structured format Characteristics of trial, e.g., Protocol title Phase Randomization Primary and secondary objectives

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Trial Summary Domain from IG 3.1.2 to 3.1.3

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  1. Trial Summary Domain from IG 3.1.2 to 3.1.3 Dieter Boß September 2012

  2. Purpose of Trial Summary Domain • Submit summary of study in structured format • Characteristics of trial, e.g., • Protocol title • Phase • Randomization • Primary and secondary objectives • Actual characteristics like number of subjects, data cut-off dates • Information is provided in findings structure

  3. Trial Summary Specific Contents • Standardized parameters – TSPARM • Listed in CDISC Controlled Terminology (CCT) • core concept: required, expected, permissible • Standard code lists or formats assigned to many parameters • Core concept reflects requirements for study protocol disclosure in publicly available clinical trial registries like CT.GOV • Values – TSVAL • Null Flavor Values – TSNVAL • Since Trial Summary Update to 3.1.2 • To provide standardized missing codes for not available required parameters, e.g., “NA“

  4. Changes from 3.1.2

  5. Trial Summary Parameters in CCT • CCT does not contain parameters • AGEU • DESIGN • Does contain parameters • DOSE • DOSU • DOSFRQ • ROUTE • not listed any more in list of required or expected parameters

  6. Issues with Parameter List • Information not always easily retrievable in study protocols • Company standards needed to make TS useful within company and for submissions • Code Lists are available for majority of parameters • Don‘t invent if available • There are issues with a few special code lists

  7. Code List Issues • SNOMED • Systemized Nomenclature of Medicine • Used for: • Trial Indication - INDIC • Diagnosis Group - TDIGRP • Not licenced in many companies • Can other dictionary or sponsor terms be used?

  8. Code List Issues • NDF RT • National Drug File – Reference Terminology • Can be found via NCI website • Used for: • Pharmocological Class – PCLAS • Hard/ Impossible for data managers to identify correct term for products in development

  9. Code List Issues • UNII • Unique Ingredient Identifier • Connects to NCI Concept Code • Used for: • Investigational Therapy or Treatment – TRT

  10. Code List Issues • SRS Preferred Substance Name • FDA Substance Registration System • Can be found via FDA website • Uses UNII codes and terms • Used for: • Comparative Treatment - COMPTRT • Current Treatment – CURTRT • Only available for approved substances ?

  11. UNII is Accessible via SRS

  12. Code List Issues • DUNS • Dun and Bradstreet System to uniquely identify companies • Recommeded by ISO • Used for: • Clinical Study Sponsor – SPONSOR • Unclear how to retrieve information • Download ?

  13. Access to NDF-RT and UNII

  14. Thank You! Questions?

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