Define.xml. Not Just for Submissions Anymore. Robbert P. van Manen, M.Sc. Senior Technical Solutions Consultant July 2010

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2 Qualifications Product Guidance This presentation contains directional statements related to the features and availability of one or more unreleased products. These statements represent current intentions and goals which are subject to change or withdrawal at any time without further notice. Safe Harbor This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to the features and availability of one or more unreleased products. These statements are subject to a variety of risks and uncertainties, including without limitation, technical difficulties encountered in the development of the planned product or changes in product plans which might result in the failure of Phase Forward to release the product as scheduled, as described, or at all, as well as the risks set forth in Phase Forward's public filings with the Securities and Exchange Commission. We do not assume any obligation to update the forwardlooking statements contained in this presentation. 2

3 Agenda 3

4 4 Introduction and Background

5 What is define.xml? 5

6 What is define.xml? 6

7 How is define.xml commonly used today? 7

8 How can define.xml be used? 8

9 9 Specifying the contents and generating a define.xml

10 Specifying the content of the define.xml: Datasets Description Structure Class Purpose Keys Repeating Is_Referenc Adverse Events One record per adverse event per subject Events Tabulation STUDYID, UYes No Clinical Events One record per event per subject Events Tabulation STUDYID, UYes No Demographics One record per subject Special Pur Special Purpose Domains STUDYID, UNo No 10

11 Specifying the content of the define.xml: Variables DATASET VARIABLE_VARIABLE_CODELIST VARIABLE_VARIABLE_VARIABLE_ORIGIN Computation_Method DM STUDYID string IDENTIFIERReq CRF DM DOMAIN string RESULT QUReq CRF RECODE_DMDOMAIN DM USUBJID string IDENTIFIERReq CRF DM RFSTDTC string RESULT QUExp CRF DM RFENDTC string RESULT QUExp CRF DM SITEID string RESULT QUReq CRF DM AGE integer RESULT QUExp CRF DM AGEU AGEU string RESULT QUExp CRF DM SEX SEX string RESULT QUReq CRF RECODE_SX DM RACE RACE string RESULT QUExp CRF DM ARMCD string RESULT QUReq CRF DM ARM string RESULT QUReq CRF DM COUNTRY string RESULT QUReq CRF DM DMDTC string RESULT QUPerm CRF RECODE_DT DM DMDY integer RESULT QUPerm CRF 11

12 Specifying the content of the define.xml: Codelists Codelist Codelist Name Code Value Decode Value ISO 3166 ISO 3166 Country code ISO 8601 ISO 8601 Date Time Format ACN Action Taken with Study Treatment DOSE INCREASED DOSE INCREASED ACN Action Taken with Study Treatment DOSE NOT CHANGED DOSE NOT CHANGED ACN Action Taken with Study Treatment DOSE REDUCED DOSE REDUCED ACN Action Taken with Study Treatment DRUG INTERRUPTED DRUG INTERRUPTED ACN Action Taken with Study Treatment DRUG WITHDRAWN DRUG WITHDRAWN ACN Action Taken with Study Treatment NOT APPLICABLE NOT APPLICABLE ACN Action Taken with Study Treatment UNKNOWN UNKNOWN OUT Outcome of Event FATAL FATAL OUT Outcome of Event NOT RECOVERED/NOT RESOLVED NOT RECOVERED/NOT RESOLVED OUT Outcome of Event RECOVERED/RESOLVED RECOVERED/RESOLVED OUT Outcome of Event RECOVERED/RESOLVED WITH SEQUELAE RECOVERED/RESOLVED WITH SEQUELAE OUT Outcome of Event RECOVERING/RESOLVING RECOVERING/RESOLVING OUT Outcome of Event UNKNOWN UNKNOWN 12

13 Specifying the content of the define.xml: Computational Methods Reference_Name RECODE_SX RECODE_DT RECODE_DMDOMAIN RECODE_AEDOMAIN RECODE_CEDOMAIN Computation_Method M=Male;F=Female; ISO to SASDATE DOMAIN=DM DOMAIN=AE DOMAIN=CE 13

14 14 Additional uses for the contents of the define.xml

15 Additional uses for the contents of the define.xml The specification is stored in the metadata database 15

16 Additional uses for the contents of the define.xml The specification is used to create a Library 16

for a study Changes to Standard will Cascade Changes to

17 Additional uses for the contents of the define.xml The Standard Library is used to specify the model for a study Changes to Standard will Cascade Changes to the study spec to enable study requirements will remain local. 17

specification The information required for the define.

18 Additional uses for the contents of the define.xml Managing differences between standard library and study specification The information required for the define.xml can be compared and reported so that differences required for a study and be managed. 18

19 Additional uses for the contents of the define.xml The specification can be pointed to data that is generated and/or received from CROs. 19

20 Additional uses for the contents of the define.xml The specification can be pointed to data that is generated and/or received from CROs and ensure the data conforms to the specification 20

21 Additional uses for the contents of the define.xml Generating Oracle table structures for storing the data so that it is accessible to other applications 21

22 22 Combining define.xml contents with other functions

23 Combining define.xml content with other functions Macro Parma1 Param2 Param3 Param4 Param5 Param6 SELECT INDS=ADSL ADLB BYVAR=USUBIJ SUBSET SELVAR= LABCODE POPFL ANALFL SELVAL= (AST ALT TBIL ALP) (1) (1) SPECIAL PROGRAM= MYPROG>SAS LOCATION=..\STUDY\ANAPRO\4JUL ANALYSIS PERCNORM IN= AST ALT TBIL ALP OUT= ASTFL ALTFL TBILFL ALPFL CRIT = ULN COMP = >, >, >, < CONSTANT= 3, 3, 1.5, 2 Using metadata and stored macros, data processing can be made more efficient 23 ANSP INDS = Data OUTDS = PLOT IDVAR = USUBIJ POPFL ANALFL TRANSPVAR = LBSTRESN COPYVAR = BYVAR = ) PLOT X= TBIL Y=AST XREF=1.5 YREF=2.0 SYMBOL=ASTFL TITLE FOOTNOTE TITLE1= Study 1 FOOTNOTE1= Analysis Popula tion TITLE2= La b Analysis for 4Jul Mee ting FOOTNOTE2= Criteria as per Hy's La w

24 Conclusions and Questions 24

Thank you robbert.vanmanen@phaseforward.c om Copyright 2010 Phase Forward Incorporated.

25 Thank you om Copyright 2010 Phase Forward Incorporated. Phase Forward, InForm and the Phase Forward logo and other related logos are trademarks or registered trademarks of Phase Forward Incorporated in the U.S. and other jurisdictions. Other marks may be the trademarks or registered trademarks of their respective owners. Any reliance on these materials is at the relying party s sole risk and will not create any liability or obligation for Phase Forward. The information contained in these materials (i) is provided without warranty of any kind, (ii) references only laws, regulations and rules as in effect at the time of publication and (iii) is subject to change without notice. Nothing contained in these materials should be construed as the rendering of legal advice, and readers are advised to seek the appropriate advice for specific cases Phase Forward Incorporated. All rights reserved. 25

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