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

2. 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 20-Aug-12

3. 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 20-Aug-12

4. 4 Changes from 3.1.2 IG 3.1.2TS UpdateIG 3.1.3CCT No of parameters 2043 47 Required-28 - Conditionally Required (incl. If Applicable) -15 - 20-Aug-12

5. 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 20-Aug-12

6. 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 Dont invent if available There are issues with a few special code lists 20-Aug-12

7. 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? 20-Aug-12

8. 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 20-Aug-12

9. 9 Code List Issues UNII Unique Ingredient Identifier Connects to NCI Concept Code Used for: Investigational Therapy or Treatment – TRT 20-Aug-12

10. 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 ? 20-Aug-12

11. 11 UNII is Accessible via SRS 20-Aug-12

12. 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 ? 20-Aug-12

13. 13 Access to NDF-RT and UNII 20-Aug-12

14. 14 Thank You! Questions? 20-Aug-12