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Resources
2016 |
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- 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 |
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- 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 |
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- 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 |