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Completed Projects Deliverable Project Page
RoadmapAccomplishmentsNonclinical Standardization Roadmap Team
Define.xml Code List HandlingSEND FAQ - DEFINE.XML sectionDemystifying Define.xml Codelists for Nonclinical Studies
Clinical Endpoint predictivityActivities completedNICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
Historical ControlsCompleted tasksNonclinical Historical Controls
Histopathology VisualizationDeliverablesVisualization of Group Related Differences in Histopatholgy Data
Interorganizational SENDAccomplishmentsInterorganizational SEND
Industry DiscussionSee project page for comments accumulatedNonclinical Working Group Industry Discussion Group
Emerging TechnologiesIG search tool (to add link)Emerging Technologies Collaboration
Test Submission ForumSee page for discussionTest Submission Forum Group
BiomarkersPoster and White PaperInvestigating Endpoint Modeling - Biomarkers
SEND Data for AnalysisAnnotated examplesApplication of SEND Data for Analysis
Data VisualizationCSS 2019 PosterData Visualisation as an Enabler for Nonclinical Safety Signal Detection
Data Consistency White Paper

Data Consistency: SEND Datasets and Study Report 

Testing Simplified TS Examples Against FDA Technical Rejection CriteriaPresentation and eCTD Sequence submitted to the FDA Testing Simplified TS Examples Against FDA Technical Rejection Criteria

Resources

2016 
  • The SEND Implementation Wiki- Crowd-sourced Practical SEND Information
  • Investigating Endpoint Modeling for SEND Datasets
  • The Nonclinical SDRG Winner: FDA/PHUSE Collaboration Award!
  • Graphical Display of Histopathology Data from Toxicology Studies: An Industry Survey
  • FDA SEND Submissions: Does the Pinnacle 21 Open-source Community Validator Predict FDA Findings?

Click here for all posters and presentations displayed at the 2016 CSS in Silver Spring

2015 
  • Template and User Guide for the Nonclinical Study Data Reviewer’s Guide (SDRG)
  • Mapping Micronucleus, Motor Activity and Ocular Irritation Study Data in SDTM Using the Nonclinical Custom Domain Resource
  • SEND data from Small/Medium Service Providers: How prepared are they to supply data in SEND format?
  • Template to Facilitate Creating Pharmacokinetic SEND datasets
  • SEND Implementation Guide Search Tool
  • Adding In Vivo Mammalian Cytogenetics Data to SEND and ToxML

Click here for all posters and presentations displayed at the 2015 CSS in Silver Spring

2014
  • Steps in the generation of SEND datasets between multiple organisations
  • Application of a Quality System to the Generation and Submission of SEND Files
  • Selecting a CRO for Creating and Integrating SEND Datasets from Multiple organisations
  • Recommendations on Use of the Clinical SDRG Model for Nonclinical Data Submission
  • How to Design a Custom SDTM Domain for Nonclinical Data
  • Community opinions on the the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies
  • Communication: So, we have a new standard; now what?

Click here for all posters and presentations displayed at the 2014 CSS in Silver Spring


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