Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed)

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1 Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed) Lex Jansen TAKE Solutions CDISC Atlantic User Group Meeting

2 Regulatory Landscape (FDA) July 2004 FDA adds Study Data Specifications v1.0 to draft ectd Guidance. This specification references the CDISC SDTM for data tabulation datasets

3 Regulatory Landscape (FDA) March 2005 Study Data Specifications v1.1: Specifications for Data Sets Documentation - data definitions - annotated case report forms (CRFs) The specification for the data definitions for datasets provided using the CDISC SDTM is included in the Case Report Tabulation Data Definition Specification (define.xml) developed by the CDISC define.xml Team Data Definition for other data sets follows: Providing Regulatory Submissions in Electronic Format NDA (1999), which is the define.pdf

data definitions for datasets provided using the CDISC SDTM is included in the Case Report Tabulation Data Definition

4 Regulatory Landscape (FDA) 2006 CDISC SDTM/ADaM Pilot Project: Collaborative Pilot project with FDA and industry to test how well the submission of CDISC compliant data sets and associated metadata meets the needs of both medical and statistical FDA reviewers Generation of ICH E3/eCTD clinical study report (CSR) using the CDISC data models Data Definition Tables were provided in XML format (CRT- DDS, define.xml)

needs of both medical and statistical FDA reviewers Generation of ICH E3/eCTD clinical study report

5 Regulatory Landscape (FDA) April 2006 FDA issues final Guidance for Industry: Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Product Applications and Related Submissions Using the ectd Specifications Application Table of Contents: XML instead of PDF This guidance now has the following reference for datasets: See the associated document "Study Data Specifications" for details on providing datasets and related files (e.g., data definition file (define.xml), program files)

Contents: XML instead of PDF This guidance now has the following reference for datasets: See the associated document "Study

6 Regulatory Landscape (FDA) September 29, 2006 FDA announces the withdrawal of the three guidances for Providing Submissions in Electronic Submission Format (NDAs, ANDAs, and Annual Reports for NDAs and ANDAs) These guidances are being withdrawn because they are no longer consistent with ectd guidance After December 31, 2007 ectd is the preferred format for electronic submissions: - consistent with FDA s technical capabilities - more efficient than other choices

being withdrawn because they are no longer consistent with ectd guidance After December 31, 2007 ectd is the

7 Regulatory Landscape (FDA) December 11, 2006 FDA proposes to amend regulations governing the format for data submissions for NDAs, BLAs and ANDAs and their supplements and amendments Proposal mandates that data must be submitted and provided in an electronic format that the FDA can process, review, and archive. Proposal would require the use of standardized data structure, terminology, and code sets contained in current FDA guidance (SDTM) to allow for more efficient and comprehensive data review. Provides a two-year transition period for implementation This would be Notice of Proposed Rulemaking in March 2007

8 Data Definition Tables 1999 Guidance: sponsor has to document submitted data by including data definition tables (define.pdf) and annotated case report forms (blankcrf.pdf)

9 Data Definition Tables 1999 Guidance: sponsor has to document submitted data by including data definition tables (define.pdf) and annotated case report forms (blankcrf.pdf)

10 Data Definition Tables As of January 1, 2008: follow ectd guidance and document submitted data by including data definition tables (define.xml) and annotated case report forms (blankcrf.pdf)

11 Data Definition Tables As of January 1, 2008: follow ectd guidance and document submitted data by including data definition tables (define.xml) and annotated case report forms (blankcrf.pdf)

12 Data Definition Tables From the CDISC SDTM / ADaM Pilot project: Define.xml + XSL style sheet = html

13 Data Definition Tables From the CDISC SDTM / ADaM Pilot project: Define.xml + XSL style sheet = html

14 Data Definition Tables CDISC SDTM / ADaM Pilot project report: A major issue identified by the regulatory review team was the difficulty in printing the Define file. The style sheet used in the pilot submission package was developed with the primary target of web browser rendering, which is not readily suited to printing. Reviewers who attempted to print the Define file found that the file did not fit on portrait pages, that page breaks were not clean, and that printing only a portion of the file was difficult. Opening the document in another application (e.g., Microsoft Word) provided a work-around, but was not an option that was user friendly or efficient.

Reviewers who attempted to print the Define file found that the file did not fit on portrait pages, that page breaks were not clean, and that printing only a portion

15 Data Definition Tables CDISC SDTM / ADaM Pilot project report: This problem could be viewed as an implementation issue that sponsors will need to handle, after discussing the issue with their FDA reviewers. For example, a sponsor might choose to provide two versions of the style sheet XML for viewing and PDF for printing. Ideally, a reminder of the issue would be included somewhere in the CRT-DDS guidance (e.g., a note that consideration be given to how the sponsor will respond to a request from reviewers for a print-friendly version of the style sheet). It should be noted that the regulatory review team for the pilot project emphasized that the ability to print the document would be essential for the future use of XML files.

Ideally, a reminder of the issue would be included somewhere in the CRT-DDS gu

16 Define.xml define.pdf How to create the PDF rendition of define.xml? Original metadata in SAS SAS ODS PDF define.pdf But what if we only have the SAS.XPT files and the define.xml? Use XML based tools to convert XML to PDF (XSL Formatting Objects)) Possible, but very complicated to develop in-house. Standard commercial solution might not be available since define.xml is extensible

Use XML based tools to convert XML to PDF (XSL Formatting Objects)) Possible, but very

17 Define.xml define.pdf Solution: SAS XML Mapper + SAS ODS PDF SAS XML Mapper: free stand alone Java application available on the SAS product distribution disks Uses XPATH to create a MAP file that transforms XML to rows and columns In SAS: LIBNAME define XML define.xml XMLMAP= mymap.map ; PROC COPY IN=define OUT=work; RUN;

application available on the SAS product distribution disks Uses XPATH to create

18 Define.xml define.pdf Solution: SAS XML Mapper + SAS ODS PDF You will need to create a relational data model to convert the XML hierarchy to the 2- dimensional SAS data sets that can be joined

19 Define.xml define.pdf Solution: SAS XML Mapper + SAS ODS PDF You will need to create a relational data model to convert the XML hierarchy to the 2- dimensional SAS data sets

20 Define.xml define.pdf

21 Define.xml define.pdf

22 Define.xml define.pdf

23 Define.xml define.pdf

24 Questions Contact:

ectd Digital Handbook Table of Contents

ectd Digital Handbook Table of Contents Introduction by Emily Ethridge, Editor, FDAnews Part 1 Tutorial Section 1.0 ectd Tutorial Table of Contents. This FDA tutorial, consisting of seven PowerPoint presentations,