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
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