Nonclinical Topics Archive

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

2022
Recommendations for SEND Dataset QC Best Practices SEND Dataset QC Best Practices – Common explanations for FDA / CDISC validation issues

2019
Nonclinical SEND Implementation Survey 2019 Five Perspectives on SEND Implementation Challenges 2019 Cross-Study Analysis Workshop - BioCelerate and FDA

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?

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

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?