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The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008
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The application of STDM in a no-profit and disease specific organisation - CDISC Italian User Group, Milan (Italy), 2008

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  • 1. CDISC Italian-Speaking User Group Meeting 2008 Milan, 16th May 2008 The Application of SDTM in a no-profit and disease specific organization Angelo Tinazzi Medical Informatics and Biometry UnitEarly Drug Development SENDO Tech S.r.l. – Milan; ITALY In Oncology
  • 2. SENDO Background• No profit organisation acting as a CRO• Disease Oriented (Oncology)• Early Drug Development – Phase I (in humans) for new compounds and for new combinations (Ib-sponsored or investigator initiated), Phase II (single indication e.g. Advanced Breast Ca.) – No involvement in regulatory data submission?? So why bother about (CDISC) standards ?? A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 2 The Application of SDTM in a no-profit and disease specific organisation
  • 3. SDTM Pitfalls at SENDO• Oncology heterogeneity• New compounds, New Schema à unknown mechanism• Phase I in patients• Customer-oriented – Internal (Strong Principal-Investigator leadership) – External (Sponsor)However some ‘standardisation’ can be applied A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 3 The Application of SDTM in a no-profit and disease specific organisation
  • 4. SENDO Customers• A multinational company imposed its standards• A big national company imposed its ‘recent’ (<5 years) standards• Other companies/biotechs accept SENDO ‘rules’ – Some are starting asking “is your database CDISC compliant?” …. Is this an appropriate question?• Common terminology not yet applied – e.g. several ways for defining AE drug relationship A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 4 The Application of SDTM in a no-profit and disease specific organisation
  • 5. Existing standards and projectsin OncologyStandard Cancer Terminology• Tumor-extension classification (e.g. TNM)• Tumor response evaluation (e.g. RECIST Criteria)• NCI-AE Common Toxicity CriteriaNCI and CDISC collaboration for Controlled Terminology CDISC Initiative• CDISC Review• Enterprise Vocabulary Services (EVS)• Cancer Data Standards (caDSR) A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 5 The Application of SDTM in a no-profit and disease specific organisation
  • 6. SENDO SDTM ImplementationBack to Origin (2003)Existing standards• By module (two digits abbreviation)• Variable naming convention – Module abbreviation + Variable abbreviation + Variable Type i.e. C for Character, N for Numeric, D for Date e.g. AEEVEC for Adverse Events Verbatim• Standard (SI Laboratory Standard Conversion), Therapeutic (Oncology) and Company standard terminology• Tools for Clinical Data Review A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 6 The Application of SDTM in a no-profit and disease specific organisation
  • 7. References used in this presentation• CDISC SDTM Implementation Guide (IG) – Version 3.1.1• Study Data Tabulation Model (MOD) - Version 1.1• All roads lead to SDTM? Which one shall we take? PhUSE 2007, Paper RA08 (PHUSE)• Creation of Submission and Analysis Datasets by following SDTM and ADAM requirements. PhUSE 2007, Paper RA05 (PHUSE) CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 7 The Application of SDTM in a no-profit and disease specific organisation
  • 8. SDTM Implementation – when toimplement?• Build SDTM entirely in the CDMS (pre)• Build SDTM entirely on the ‘back-end’ (post)• Build SDTM using a Hybrid approach (hybrid)CDMS=Clinical Data Management System CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 8 The Application of SDTM in a no-profit and disease specific organisation
  • 9. SDTM ImplementationOther points to consider• CDMS metadata libraries support• CDMS flexibility in clinical database updates• CDMS flexibility in performing complex derivations• Your Data-Management team ‘language’• Biostat preferences• Existing data-management and analysis standard toolsThe decision should be driven by the existing company standards regulating the entire clinical trial process from data collection to data analysis& PHUSE A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 9 The Application of SDTM in a no-profit and disease specific organisation
  • 10. SDTM Implementation – SENDO approach (1) Hybrid Model • CDMS Restrictions • About 70% of SDTM applied in the CDMS • CDMS data-collection oriented StandardOracle (CT/OC) SAS SENDO-ADAM SAP/TLGOther Prop. DbCDMS “source data” SAS SENDO-SDTM CDISC-SDTMSDTM-like Programming Std Med Review Tools Listings Pt Profiles Other tools Full CDISC-SDTM + Sponsor Requirements CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 10 The Application of SDTM in a no-profit and disease specific organisation
  • 11. SDTM Implementation – SENDO approach (2)Apply a Hybrid Model (SDTM-SENDO)In the CDMS• SDTM tables (standard domains) naming• SDTM variables naming (including derived variables derived in SAS)• Simple derivations• If a sponsor plans to submit data to FDA, apply complete post-processing in SAS A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 11 The Application of SDTM in a no-profit and disease specific organisation
  • 12. SDTM Implementation – SENDO approach (3)SAS Post-processing Mapping (1)• Direct Mapping• Complete variables mapping (Rename) e.g. STDTCàAESTDTC, STDTCàEXSTDTC & MOD Sect 2.2.5 [Timing Variables]• Complete derivations Start Date/Time of an observation• Combine multiple CDMS variables e.g. datepart variables A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 12 The Application of SDTM in a no-profit and disease specific organisation
  • 13. SDTM Implementation – SENDO approach (4)SAS Post-processing Mapping (2)• Combine multiple CDMS datasets – Horizontal to Vertical when required e.g. vital signs – Match ‘temporary’ non-standard modules e.g. chemistry + hematologyàLB• Standardize format values• Apply new Formats e.g. ISO date format• Creation/Update of Trial Design Datasets MOD Sect 7.1 [Trial Design Datasets] Description of key aspects of the planned conduct of a clinical trial (e.g. arms) A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 13 The Application of SDTM in a no-profit and disease specific organisation
  • 14. SDTM Implementation – SENDO approach (5)Cons of Hybrid Model• Additional transformations are required therefore you need: – Additional Specifications – Additional Programming Activities – Additional Validation• The data-management staff still speaking an other language (is it a pro or a con?)• Possible delays in delivering SDTM (and ADAM) A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 14 The Application of SDTM in a no-profit and disease specific organisation
  • 15. SENDO map to SDTM – Issues (1)• CDMS modules (CRF section) that map to one corresponing SDTM domain • e.g. Laboratory and Normal Ranges• SDTM Variables contain decoded text rather than code (and format/codelist to be applied)• Other….specify à In SUPPQUAL & MOD sect 4.4 Non-standard variables not presently included in the general-observation-class models. A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 15 The Application of SDTM in a no-profit and disease specific organisation
  • 16. SENDO map to SDTM – Issues (2)• Sometimes it can be considered not analysis- oriented…but this is sometimes due to programmers attitude • e.g. vertical vs horizontal structure• Unclear where endpoints such death and survival should be collected • DS? • ad-hoc module? Findings or Events Class? A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 16 The Application of SDTM in a no-profit and disease specific organisation
  • 17. SENDO map to SDTM – Deviations (1)• Map new variables rather than using SUPPQUAL & MOD sect 4.4 Non-standard variables not presently included in the general-observation-class models. & MOD sect 2.2.5 [Timing Variables]• --DY variable = 0 Actual study day of Visit/Collection/Exam in integer days & IG sect 4.1.4.4 There is no study day 0• Common terminology not fully-integrated• Use of code rather than decode A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 17 The Application of SDTM in a no-profit and disease specific organisation
  • 18. SENDO map to SDTM – Deviations (2)• AESEV instead of AETOXGR• LBCTC (new variables) instead of LBTOX/LBTOXGR• Assigned dose-levels in Trial Arms table & MOD sect 3.2.2 Planned Arms in the trial A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 18 The Application of SDTM in a no-profit and disease specific organisation
  • 19. SENDO map to SDTMModule-specific issues (AE)• Change in AE-condition in the same visit – e.g. severity grade (IG 3.1.2–Findings CF module to be applied)• Multiple Action taken and Drug Relationship for drug- combination trials• “Any AE occured” is not allowed – & IG “When adverse events are collected with the recording of free text, some sponsors may enter a record into the data management system to indicate no adverse events, for a specific subject. For these subjects, do not include a record to indicate that there were no events unless AEOCCUR is being used to represent records for non-occurring events. Otherwise, records should be included in the submission dataset only for adverse events that have actually occurred” !!! AEOCCUR removed from IG 3.1.2 !!! A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 19 The Application of SDTM in a no-profit and disease specific organisation
  • 20. SENDO map to SDTMModule-specific issues (EX)Reasons for treatment change collected in ‘SUPPQUAL’(EX.EXADJ not applicable for multiple occurences) EX SUPPEX& IG sect 6.1.2 02 2008 01The Exposure domain model records the details of a 50 5 xsubject’s exposure 51 protocol-specified study treatment. to 5 xInterventions (EX) datasetSTUDYID USUBJID DOMAIN VISITNUM EXSEQ EXTRT EXSTDTCS075MY01 01002 EX 2 2 DRUG1 2008-02-01SUPPEX (or EM) dataset STUDYID USUBJID RDOMAIN IDVAR IDVARVAL QNAM QLABEL QVAL S075MY01 01002 EX EXSEQ 2 RED Dose Reduced 1 S075MY01 01002 EX EXSEQ 2 DELAY Treatment Delayed 1 CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 20 The Application of SDTM in a no-profit and disease specific organisation
  • 21. Creating a NEW Domain (1)• Check that none of the existing published domains will fit the need• Use existing models as prototype or choose the general observation class….How to determine where data belong in the SDTM, & IG Page 129• Assign a 2–letter domain code (suggested X_?)& IG Page 13 A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 21 The Application of SDTM in a no-profit and disease specific organisation
  • 22. Creating a NEW Domain (2)Select the SDTM General Observation ClassesUnderstand the class your domain belongs to• InterventionsTreatments Change your (my) mind. or Procedures intentionally administered either specified by Rather than Analysis oriented:study protocol or other treatments(Investigational Treatments, Characteristics • Patient Conc Medications)• Events • Treatment Exposure • EfficacyOccurences or incidents indipendent of planned study evaluationoccuring before • Safety trial or during the(Adverse Events, Medical History) oriented ….‘data-collection’• FindingsPlanned evaluations to address specific questions(Physical Evaluation, Laboratory) B CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 22 The Application of SDTM in a no-profit and disease specific organisation
  • 23. Creating a new Domain (3)SENDO-SDTM new modules• Prior Tumor History – Prior Systemic Therapies (ST) – Prior Radiotherapies (PR)• Tumor Response Evaluation (TAàCA)• Follow-up (FP)• Ad-hoc study modules (i.e. lymphoma-non- hodgkin assessment ad-hoc measurements) A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 23 The Application of SDTM in a no-profit and disease specific organisation
  • 24. Creating a NEW Domain (4)• Add variables as follows (& IG sections)• Use existing models as prototype or choose the general observation class CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 24 The Application of SDTM in a no-profit and disease specific organisation
  • 25. Creating a NEW Domain (5)Assign a variable name (& IG Section 10.4) CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 25 The Application of SDTM in a no-profit and disease specific organisation
  • 26. Creating a new Domain (6)Example: Tumor Assessment (CA) IV SEGMENT 01 05 0 5 10 2007 20 PANCREATIC 01 98 0 5 10 2007 22 NODULE• Periodic (every 2 months/visits) review of tumor lesions dimension• Measurement of Tumor-Lesions – Classified as Target or Non-Target or New – Description – Organ location – Assessment date – Method used – Measure (mm) CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 26 The Application of SDTM in a no-profit and disease specific organisation
  • 27. Creating a new Domain (7)Example: Tumor Assessment (CA) --SPID Optional Sponsor-defined reference --CAT number. define a category of related Used to Perhaps pre-printed on the --TEST IV SEGMENT 1 CRF as an explicit line identifier on a records. Examples: HEMATOLOGY, 5 0 5 10 2007 20 Concomitant Medications page. to the --SCAT name, corresponding Verbatim CHEMISTRY the test or examination Used variable, a further categorization topic to define --METHOD 1 level for obtain test measurement or used to a group of or examination Method of the the related records. PANCREATIC 98 0 5 10 2007 finding. Examples: Platelet Count, NODULE 22 Example: DIFFERENTIAL. Systolic Blood Pressure, etc. Variables which identify the study, the subject, Variables which describe the timing of an the domain and the seq nr. of record observation (e.g. date collection)STUDYID USUBJID DOMAIN CASEQ CASPID VISIT VISITNUM CADTCS075MY01 01002 CA 1 1.01 BASELINE 1 2007-10-05S075MY01 01002 CA 2 1.02 BASELINE 1 2007-10-05 Variables, text or number, that describe the results or additional traits of the observation (e.g. units)CACAT CATEST CASCAT CAMETHOD CAORRES CAORRESUTARGET IV SEGMENT 5 1 20 MMTARGET PANCREATIC NODULE 5 1 22 MM CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 27 The Application of SDTM in a no-profit and disease specific organisation
  • 28. SAS Tools supporting SDTM - Proc CDISC (1)• SDTM 3.1 data validation available in SAS 9.1.3 – Service pack 4 available for download at ftp.sas.com/techsup/download/hotfix/hotfix.html – 15 SDTM modules supported – Various checks on models / variables attributes (e.g. variables not defined in the domain) – Various checks on models / variables contents (e.g. missing values in required variables) CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 28 The Application of SDTM in a no-profit and disease specific organisation
  • 29. SAS Tools supporting SDTM - Proc CDISC (2)Example validating DM dataset CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 29 The Application of SDTM in a no-profit and disease specific organisation
  • 30. SAS Tools supporting SDTM - Proc CDISC (3)Example validating DM dataset Expected variable warning Variable AGEU is expected in this domain(DM), but is not present Permissable variable note Variable DMDY is permitted in this domain (DM), but is not present Data Error Incorrect ISO time-units Variable REFNDTC has incorrect content in observation 4 Incorrect data is 10-12-2008 A time or date component was outside expected range C CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 30 The Application of SDTM in a no-profit and disease specific organisation
  • 31. (SENDO) SAS tools created• Macro routines library – Automatic Creation of dataset structures from metadata definition files (matrix datasets) – Standard derivation (i.e. date in ISO format) – Standard terminology application (i.e. Laboratory Conversion, CTCAE common toxicity criteria) – Other complex derivations CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 31 The Application of SDTM in a no-profit and disease specific organisation
  • 32. Future improvements at SENDO (1)• Review current terminology• Full implementation of other SDTM elements to automatize data-quality/review processes – Trial Design Datasets – Relationship (e.g. AEàCM for linking action taken with corresponding concomitant medications)• Try to armonize PK and other data from external providers• Complete ADAM implementation A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 32 The Application of SDTM in a no-profit and disease specific organisation
  • 33. Future improvements at SENDO (2)Adopt 3.1.2 improvemente.g. Protocol Deviations (Section 6.2.4.2 IG 3.1.2)The intent of the DV domain model is to capture protocol deviations thatoccured during the course of the study (other than inclusion/exclusion criteria)as per ICH E3 Section 10.2STUDYID USUBJID DOMAIN DVSEQ DVTERM DVDECOD EPOCH DVSTDTCS075MY01 01002 DV 1 NO BLOOD MINOR CYLE01 SAMPLE AT DAY 8 CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 33 The Application of SDTM in a no-profit and disease specific organisation
  • 34. Conclusion - SDTM (CDISC) Criticism?• Still SAS v5 transport dataset dependence – Variable naming (8) limitation – Character Variable length (200) limitation• Use of domain abbreviation in variable name• SDTM is not always suitable for data-entry and data-validation A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 34 The Application of SDTM in a no-profit and disease specific organisation
  • 35. Conclusion - SDTM (CDISC) Alerts?• Applying SDTM is not just a variable renaming activity• Hybrid model is a good compromise• Keep up-to-dated. If possible be involved in draft documents review• Training• Find the answers using the CDISC public forum www.cdisc.org/discussions/index.html AB CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 35 The Application of SDTM in a no-profit and disease specific organisation
  • 36. Conclusion - SDTM (CDISC) Requests?• A model for external peer reviewed data e.g. Study endpoints such as tumor response CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 36 The Application of SDTM in a no-profit and disease specific organisation
  • 37. Conclusion - SDTM (CDISC) Benefits?• Standardisation improves data-quality• Tools Re-usability e.g. data-listings and patient profiles for clinical data review• Standardisation is possible even in a non-commercial (no-profit) organisation• Academic Organisations should consider it for better data(knowledge)-sharing e.g. Meta-analysis A CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 37 The Application of SDTM in a no-profit and disease specific organisation
  • 38. Thanks and QuestionsMany thanks to all SENDO MIBU Staff• Alessandro Cattaneo• Anna Compagnoni• Enrica Paschetto• Sonia ColombiniAngelo Tinazzi, SENDO Tech S.r.l.Medical Informatics and Biometry UnitVia Visconti di Modrone 1220122 Milanotinazzia@sendo-org.it CDISC Italian-Speaking Usergroup Meeting 2008 – Angelo Tinazzi (SENDO Tech S.r.l.) 38 The Application of SDTM in a no-profit and disease specific organisation

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