Define-XML Codelist Recommendations: 27-03-19: The Demystifying Define-XML project has provided recommendations for specific problems/questions encountered, when fulfilling the Define-XML codelist section for nonclinical studies.
Investigating Endpoint Modeling Biomarkers, ADA Data & Immunophenotyping Version 1.0: 03-Jan-17: The PhUSE Investigating Endpoint Modeling project team embarked on an investigation in 2015–2016, to determine suitable ways to model endpoints, which are not modeled in the SEND Implementation Guide (SENDIG v3.0) and to develop a methodology for the inclusion of data such as biomarker, anti-drug antibody (ADA) and immunophenotyping results. This paper describes recommendations for a methodology to include data such as biomarkers into a SEND dataset and the decision making process utilised. The paper presents possible best practices for inclusion of unmodeled endpoints with a consistent methodology.
Journal Article: Graphical Display of Histopathology Data from Toxicology Studies for Drug Discovery and Development: An Industry Perspective: Histopathology data comprise a critical component of toxicology studies and are typically presented as organ-specific incidence counts, tabulated in study reports. Various software applications are available to convert histopathology data into graphical displays for visual presentation. This article was published in the Regulatory Toxicology & Pharmacology Journal, Volume 82, December 2016, pages 167–172.
Visualization of Group-related Differences in Histopathology Data: Deliverables from the project team included three posters presented at FDA/PhUSE CSS meetings and one publication. It is the project team's intent to place HistoGraphic on a publicly accessed site for downloading.
Data Consistency: SEND Datasets and Study Report: The Data Consistency: SEND Datasets and the Study Report Working Group project formed at the PhUSE CSS 2016 and was tasked with identifying and addressing potential inconsistencies between the study report and SEND v3.0 datasets. Team members identified scenarios which could lead to inherent differences between SEND datasets and study reports. The team created a listing of potential inconsistencies identified and associated recommendations, which are provided in this paper.
Journal Article: Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development 22-Apr-14: Pharmaceutical research and development generates enormous amounts of nonclinical and clinical data related to safety and efficacy, and the ability to manage and utilise these data is critical for discovering and developing new drugs. Information systems exist that store and analyse relationships among seemingly disparate data sets (i.e. data silos); however, to fully utilise the potential of these informatics systems, it is necessary to define basic parameters about the data and to develop concepts regarding 'interconnectivity' or relationships among disparate data sets. This article was published in the Therapeutic Innovation & Regulatory Science DIA Scientific Journal, 2014.
Roadmap for Nonclinical Data Standards and Elements to Improve Data Access: This paper identifies points to consider when implementing nonclinical standards, and sets priorities for nonclinical data types and considerations for future nonclinical standards development.
SEND Implementation Wiki: Knowledge base for SEND implementers including reference articles, links, modeling basics and FAQs.
Handling of SEND in Study Documentation: Recommendations for handling references to SEND in study documentation (e.g. protocol, contracts, etc.).
|Optimizing the Use of Data Standards
Define-XML v2.0 Stylesheet Recommendations: 07-Dec-18
Data Sizing Best Practices Recommendation: This paper provides recommendations managing the length of character variables in a submission, handling SAS transport files that exceed the maximum allowable size and documenting split domains in Define-XML.
Standardizing Data within the Inspection Site Selection Process Final Version: 26-MAY-16: Guidance for industry: Providing submissions in electronic format.
Summary of Traceability References: This paper summarises and interprets traceability references found in the public domain (e.g. conference papers, CDER Common Data Standards issue document, etc.).