CRT for eCTD submission Aurelien Guillouche, SAS programmer PhUSE, - PowerPoint PPT Presentation

CRT for eCTD submission Aurelien Guillouche, SAS programmer PhUSE, Basel, 19 th october 2009

Table of contents  Introduction  What is a CRT?  Novartis processes  Conclusion 2 | PhUSE | Paper RG06 | Aurelien Guillouche

Table of contents  Introduction  What is a CRT? • Definition • Content • Data Derivation & Handling document • Data Definition Table • Annotated CRFs / eCRFs • Summary  Novartis processes  Conclusion 3 | PhUSE | Paper RG06 | Aurelien Guillouche

Table of contents  Introduction  What is a CRT?  Novartis processes • New eCTD rules • Before: example • Novartis tools • DRA and Review • Issues  Conclusion 4 | PhUSE | Paper RG06 | Aurelien Guillouche

Table of contents  Introduction  What is a CRT?  Novartis processes  Conclusion 5 | PhUSE | Paper RG06 | Aurelien Guillouche

Introduction  CRTs are part of the electronic submission Introduction (US only at the moment) What is a CRT? Novartis processes  From the 1 st of January 2008, CRT Conclusion specifications are based on the eCTD (electronic Common Technical Document) rules.  These new rules implied a lot of changes.  How Novartis have changed processes to be compliant?  What have been encountered issues? 6 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Definition  CRT = Case Report Tabulation Introduction What is a CRT?  Required by the FDA Definition Content  Package created in order to provide to the Data Derivation & FDA the raw & derived datasets Handling document Data definition table  2 CRTs for one study : Annotated CRF/eCRF Summary • One containing only raw datasets (if needed) Novartis processes • One containing only derived datasets Conclusion 7 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Content  Package contains : Introduction What is a CRT? • SAS V5 Transport files of either the raw or derived datasets (<xxx>.xpt) Format required by FDA. Definition Content • The data definition table (Define.pdf) , regrouping : Data Derivation & - A table of content of the raw or derived datasets Handling document - Hyperlinks to the XPT files Data definition table - An alphabetical list of variables and formats Annotated CRF/eCRF Summary • The CRF / eCRF for raw CRT Novartis processes • the Data Derivation and handling Document (DDD) for derived CRT Conclusion 8 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Data Derivation & Handling document  The Data Derivation & Handling document is Introduction not required by the FDA but Novartis What is a CRT? considers the DDD as mandatory. Definition Content  The DDD should contain details which are Data Derivation & Handling document not self-explanatory by the variable label Data definition table within the data definition table. Annotated CRF/eCRF Summary  It provides further detailed explanation to the Novartis processes reviewer on special data handling issues and other data imputation rules or convention that Conclusion were used in the study. 9 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Data Definition table Introduction What is a CRT? Definition Content Data Derivation and Handling document Data definition table Annotated CRF/eCRF Summary Novartis processes Conclusion 10 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Annotated CRF/eCRF Name of the Introduction dataset What is a CRT? Definition Label of the Content dataset Data Derivation & Handling document Data definition table Annotated CRF/eCRF Summary Name of the Novartis processes variable as it appears in Conclusion the dataset 11 | PhUSE | Paper RG06 | Aurelien Guillouche

What is a CRT? Summary Introduction Define.pdf CRF What is a CRT? CRT: Definition Raw Content Raw Transport datasets Data Derivation & datasets files Handling document Data definition table Annotated CRF/eCRF Summary Transport Derived Novartis processes datasets files CRT: Conclusion Derived datasets Define.pdf DDD 12 | PhUSE | Paper RG06 | Aurelien Guillouche

Novartis processes New eCTD rules  The new electronic format of CRT required Introduction additional rules to be followed: What is a CRT? • Naming conventions (no underscores) Novartis processes • Specific folder structure (listings, analysis) New eCTD rules Before: example  No underscores: Novartis tools • Previous naming convention for a derived dataset was DRA and review Issues a_dataset. Conclusion • For old studies, underscores are removed at the moment of the translating in SAS version 5 transport files.  The specific folder structure implied to create two CRTs instead of one. 13 | PhUSE | Paper RG06 | Aurelien Guillouche

Novartis processes Before: example Before : Introduction What is a CRT? Raw and derived datasets Novartis processes in the same define New eCTD rules Before: example Novartis tools DRA and review Now : Issues Conclusion Listings CRT Raw datasets Analysis CRT Derived datasets 14 | PhUSE | Paper RG06 | Aurelien Guillouche

Novartis processes Novartis tools  A standard macro create the data definition Introduction table automatically. What is a CRT? Novartis processes  The macro works with a call of parameters, New eCTD rules the update to be compliant with the new Before: example eCTD rules have added a new parameter. Novartis tools  The different parameters are: DRA and review Issues • DVD or NODVD: to include the Data Derivation and Conclusion Handling document or not. • RAW or NORAW: to include Listings datasets or not. • eCTD: to apply the new rules during the creation of the CRT. 15 | PhUSE | Paper RG06 | Aurelien Guillouche

Novartis processes DRA and review  The programmer have to deliver the CRT to Introduction DRA (Drug Regulatory Affair) in Novartis. What is a CRT? Novartis processes  DRA is the primary contact with FDA. They New eCTD rules have to transfer CRTs. Before: example  As the CRT is the last part of the Novartis tools DRA and review programming work, these have to be fully Issues reviewed by both programmer and Conclusion statistician.  A final review is done by the project programmer and the global manager 16 | PhUSE | Paper RG06 | Aurelien Guillouche

Novartis processes Issues  FDA have recently asked us to provide more Introduction information in the data definition table. What is a CRT? Novartis processes New eCTD rules Before: example Novartis tools DRA and review Issues Conclusion  Actually, because of the automation the only document we can modify is the DDD.  The standard macro will be updated. 17 | PhUSE | Paper RG06 | Aurelien Guillouche

Conclusion  CRT: final step of Statistical Reporting work Introduction What is a CRT?  CRT is one of the most important SR Novartis processes document but the working time to create a Conclusion CRT is often underestimated…  Next step: CRT in XML format 18 | PhUSE | Paper RG06 | Aurelien Guillouche

Questions ? 19 | PhUSE | Paper RG06 | Aurelien Guillouche