Nonclinical Topics Archive

Completed Projects	Deliverable	Project Page

Completed Projects	Deliverable	Project Page
SEND Dataset QC Best Practices	White 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