"Overnight" SDTM Datasets
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1 "Overnight" Conversion to SDTM Datasets mathiesen & mathiesen AG für informatik
2 Why CDISC / SDTM? FDA is strongly encouraging sponsors to submit data in standard form as a key part of its efforts to continue with advancement of review efficiency and quality.* FDA wants SDTM *CDER Common Data Standards Issues Document, May 2011 mathiesen & mathiesen AG für informatik
3 SDTM Manually or Your ecrf generates SDTM and you get SDTM for "free" 2. Conversion from Your Legacy Data Automated "Overnight" - cost efficient Clivax is designed for both mathiesen & mathiesen AG für informatik
4 Infrastructure Simplicity Source: Dave Iberson-Hurst, CDISC FDA
5 Simplicity Clivax 5 Applications 1 Appl. Setup 16 Weeks 1 Day Without IT Specialists 100% Browser Based SDTM Mapping "Free" Not necessary Legacy Converting 1.5 Man year 7 Days
6 Conversion Project Legacy Data SDTM Rawmaterials with data points. Source Oracle System. Format SAS. Final SDTM Datasets data points. 18 Domains. 7 Supp Domains. mathiesen & mathiesen AG für informatik
7 Cooperation CRO: Software: Independent Clinical Research Consulting ICRC-Weyer GmbH, Berlin Specialist in CDISC / SDTM mathiesen & mathiesen AG, Basel Developer of CLIVAX mathiesen & mathiesen AG für informatik
8 Legacy Data / SAS mathiesen & mathiesen AG für informatik
9 SDTM Data / XML Domain EG and SuppDomain SUPPEG
10 SDTM Domain and Suppdomain
11 Legacy Data 5 Conversion Steps (Without Programming) Study Structure Analysis 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
12 Study Structure Analysis I
13 Study Structure Analysis II Working Documents XLS Domains and SuppDomains ECG Electrocardiography
14 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
15 1.1 Define Study mathiesen & mathiesen AG für informatik
16 1.2 Study Assign to CDISC mathiesen & mathiesen AG für informatik
17 1.3 CDISC / SHARE Activate
18 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
19 2. Upload / Import Raw Data
20 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
21 3. Assign Issues
22 3.1 Assign Domain
23 3.2 Assign Visits
24 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
25 4. Integrate Assigned Data in System
26 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
27 5.1 Use Share, SDTM Domain Structure
28 5.2 Assign SDTM Parameters
29 5.3 Assign SDTM Parameters II
30 5.4 SDTM / Supplement Domain - Bind
31 5.5 SDTM / Interpretation - QVAL
32 5.6 SDTM / QLABEL, QORIG, QEVAL
33 5 Conversion Steps (Without Programming) Study Structure Analysis Legacy Data 1. Define Study 2. Import Raw Data 3. Assign Issues 4. Integrate Assigned Data in System 5. Use Share, Domain Export SDTM
34 6.1 SDTM Deliver / Export
35 6.2 SDTM Deliver / Export
36 Experience / Optimizing Legacy Data SDTM Data obtained as "native" as possible (from the ecrf structure retained) Data cleaning from a high quality Unique parameter names makes life easier (according to the CDISC philosophy) Source of related data from the same SAS table (avoid mixing domains) mathiesen & mathiesen AG für informatik
37 Clivax delivers SDTM Legacy Data SDTM ("Overnight") 1. Speed up the Clinical Trial Process 2. SDTM ready before "Start" of Data Input 3. SDTM always "Included" and "Free" of charge 4. All managed by your Clinical Trial team 5. Without IT Specialists mathiesen & mathiesen AG für informatik
38 Questions and Contact mathiesen & mathiesen AG für informatik Peter Merian-Strasse Basel You will find us at Stand Number 17
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