Paper & CSS 22 Poster | SEND Dataset QC Best Practices |
Roadmap | Accomplishments | Nonclinical Standardization Roadmap Team |
Define.xml Code List Handling | SEND FAQ - DEFINE.XML section | Demystifying Define.xml Codelists for Nonclinical Studies |
Clinical Endpoint predictivity | Activities completed | NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity |
Historical Controls | Completed tasks | Nonclinical Historical Controls |
Histopathology Visualization | Deliverables | Visualization of Group Related Differences in Histopatholgy Data |
Interorganizational SEND | Accomplishments | Interorganizational SEND |
Industry Discussion | See project page for comments accumulated | Nonclinical Working Group Industry Discussion Group |
Emerging Technologies | IG search tool (to add link) | Emerging Technologies Collaboration |
Test Submission Forum | See page for discussion | Test Submission Forum Group |
Biomarkers | Poster and White Paper | Investigating Endpoint Modeling - Biomarkers |
SEND Data for Analysis | Annotated examples | Application of SEND Data for Analysis |
Data Visualization | CSS 2019 Poster | Data 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 Criteria | Presentation and eCTD Sequence submitted to the FDA | Testing Simplified TS Examples Against FDA Technical Rejection Criteria |