Trial Summary Domain from IG 3.1.2 to 3.1.3

Dieter Boß

September 2012

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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

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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“

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Changes from 3.1.2

IG 3.1.2 TS Update IG 3.1.3 CCT

No of parameters

20 43 43 47

Required - 28 28 -

Conditionally Required (incl. If Applicable)

- 15 15 -

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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

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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

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Code List Issues

• SNOMED • Systemized Nomenclature of Medicine• Used for:• Trial Indication - INDIC • Diagnosis Group - TDIGRP

Not licenced in many companiesCan other dictionary or sponsor terms be used?

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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

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

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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 ?

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UNII is Accessible via SRS

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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 informationDownload ?

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Access to NDF-RT and UNII

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Thank You!

Questions?

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