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Size: 5. 00 Kb. Tips and tricks when developing Trial Design Model Specifications that provide Reductions in Creation time. Ruth Marisol Rivera Barragan, Chiltern International, Inc., Manor, TXKeywords: TDM, Trial Design Model, Trial Elements, Trial Arms, Trial Summary, Trial Visit, Trial Inclusion, UNII, SNOMED Pages: 1. Size: 9. 84 Kb. Results- Level Metadata: What, How, and Why. Frank Dilorio, Code. Crafters, Inc., Philadelphia PA; Jeffrey Abolafia, Rho Inc., Chapel Hill, NCKeywords: Metadata, Define File, Results Metadata, ARM, end- to- end, define. Metadata repurposing, user interface design Pages: 1. Size: 3. 22 Kb. Moving up! Boquist, PAREXEL, Billerica, MA; Adam J. Sicard, PAREXEL, Durham, NCKeywords: CDISC, SDTM, ADa. M, SAS Pages: 5 Size: 2. Kb. Considerations and Conventions within the Therapeutic Area User Guides (TAUGs). Jerry Salyers, Accenture Accelerated R& D Services, Berwyn, PA; Kristin Kelly, Accenture Accelerated R& D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R& D Services, Berwyn, PAKeywords: SDTMIG, Therapeutic Area User Guide Pages: 8 Size: 5. Kb. Prepare for Re- entry: Challenges and Solutions for Handling Re- screened Subjects in SDTM. Charity Quick, Rho, Inc, Chapel Hill, NC; Paul Nguyen, Rho, Inc, Chapel Hill, NCKeywords: SDTM Re- screened Re- screening Re- enrolled SUBJID USUBJID, CDISC Pages: 5 Size: 1. Kb. SDTM Trial Summary Domain: Putting Together the TS Puzzle. Kristin Kelly, Accenture Accelerated R& D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R& D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R& D Services, Berwyn, PAKeywords: SDTM, TS, Trial Summary, CDISC Pages: 1. Size: 3. 36 Kb. Conformance, Compliance, and Validation: An ADa. M Team Lead's Perspective. John Troxell, Accenture, Berwyn, PAKeywords: CDISC, ADa. M, Conformance, Compliance, Validation Pages: 7 Size: 2. Kb. Usage of Pinnacle 2. Community Toolset 2. Clinical Programmers. Sergiy Sirichenko, Pinnacle 2. Plymouth Meeting, PA; Michael Di. Giantomasso, Pinnacle 2. Plymouth Meeting, PA; Travis Collopy, Pinnacle. Plymouth Meeting, PAKeywords: Validation, Define. Pinnacle 2. 1 Community, Open. CDISC Pages: 1. 9 Size: 9. Kb. Good versus Better SDTM: Data Listings. Mario Widel, Eli Lilly & Co, Indianapolis, IN; Henry Winsor, Relypsa Inc., Redwood City, CAKeywords: CDISC, SDTM, ICH E3, Listings Pages: 1. Size: 5. 12 Kb. Moving from Data Collection to Data Visualization and Analytics: Leveraging CDISC SDTM Standards to Support Data Marts. Steve Kirby, JD, MS, Chiltern, King of Prussia, PA; Terek Peterson, MBA, Chiltern, King of Prussia, PAKeywords: CDISC Pages: 8 Size: 8. Kb. The CDISC’s are coming!! Martinez, SAS Institute, Cary, NCKeywords: define. SAS, CDI, Clinical Data Integration, value level metadata, annotated CRF, supplemental document, yodeling, chickens, annotated case report form, computational algor .. Pages: 1. 0 Size: 3. Kb Creating Define- XML version 2 including Analysis Results Metadata with the SAS. Where's My Graph?' RDF Data Cubes for Clinical Trial Data. Tim Williams, UCB; Marc Andersen, Stat. Group. Keywords: clinical trials results, CDISC, define- xml, force network graph, data visualization, D3js, JSON, Linked Data, metadata, R, RDF, RDF data cube, Resource Description Framework, SAS, semantic web, sum .. Pages: 7 Size: 7. Kb. Download the presentation (. Kb). Clinical Data Transparency and Sharing: Update on Research Benefits, Risks and the Future. Matt Becker. Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission. Jingwei Gao; Nancy Bauer. Download the slides (. Kb). Reading and Resolving Open. CIDSC Message. Download the slides (. Kb). A Unique Way to Annotate Case Report Forms (CRFs) in PDF, Using Forms Data Format (FDF) Techniques. Boxun Zhang, Seattle Genetics Inc., Bothell, WA; Tyler Kelly, Seattle Genetics Inc., Bothell, WAKeywords: SAS, CRFs, a. CRFs, Annotation, FDF, PDF, SAS COMPGED Pages: 6 Size: 4. Kb Clinical Trials Analysis Driven by CDISC Data Standards. Kelci Miclaus, JMPKeywords: CDISC. SDTM TE, TA, and SE Domains: Demystifying the Development of SE. Kristin Kelly, Accenture Accelerated R& D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R& D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R& D Services, Berwyn, PAKeywords: CDISC Pages: 6 Size: 2. Kb. Considerations in ADa. M Occurrence Data: Handling Crossover Records for Non- Typical Analysis. Karl Miller, in. Ventiv Health, Lincoln, NE; Richann Watson, Experis, Batavia, OHKeywords: ADa. M, OCCDS, ANLzz. FL, CDISC Pages: 6 Size: 2. Kb. Proper Parenting: A Guide in Using ADa. 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Considerations in Submitting Non- Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain. Jerry Salyers, Accenture Accelerated R& D Services, Berwyn, PA; Richard Lewis, Accenture Accelerated R& D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R& D Services, Berwyn, PAKeywords: SDTM, Supplemental Qualifiers, Findings About, Interventions, Events Pages: 6 Size: 6. Kb ADa. M Implementation Roundtable Discussion. Nancy Brucken, in. Ventiv Health Clinical; Richann Watson, Experis; Steve Kirby, Theorem Clinical Research. Keywords: CDISC. Usage of Open. CDISC Community Toolset 2. Clinical Programmers. Sergiy Sirichenko, Pinnacle 2. Plymouth Meeting, PA; Michael Di. Giantomasso, Pinnacle 2. Plymouth Meeting, PA; Travis Collopy, Pinnacle. Plymouth Meeting, PAKeywords: Open. CDISC, Validator, Define. Data Converter, Clinical. Trials. gov, Toolset Pages: 1. Size: 1. 76. 5 Kb. Tackling Clinical Lab Data in Medical Device Environment. Juan Wu, Medtronic plc., Santa Rosa, CA; Min Lai, Medtronic plc., Santa Rosa, CAKeywords: Laboratory results, Lab test library, Lab unit conversion library, SDTM, LB Pages: 7 Size: 3. Kb. Summing up - SDTM Trial Summary Domain. Yi Liu, Celerion Inc., Lincoln, NE; Jenny Erskine, Celerion Inc., Belfast, Northern Ireland; Stephen Read, Celerion Inc., Belfast, Northern Ireland. Keywords: CDISC Pages: 9 Size: 6. Kb. Leveraging ADa. M Principles to Make Analysis Database and Table Programming More Efficient.
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