April 10th 2018 Minutes

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Attendees: Eric, Gaoyang, Harri, Heather, Ingeborg, Mike, Mellisa, Eunice, Rinki, Sabine, Sid, Steve, Zak, Draganov, Srinivas,

Apologies: Stella, Bharath, Karl

Agenda:

Welcome new members Stella Munuo, Dragomir Ivanov Draganov, Sameer Thapar, Enuice

  • Eunice from Merck
    • Worked as a statistical Programmer for 12 years now works supporting customers statisticians that are interested in using the data for narratives ect.
    • Draganov - From Roche in Basel - Leads a small group in TKTK within nonclinical data


Mike to review the US Connect Data Visualisations presentation and posters (Potential topics of interest to Data Visualisation)

  • Analytics, Big Data
    • Drug Induced Liver Injury (DILI) Clarification using FDA-Approved Drug Labelling and FAERS Data
    • Modeling and Text Analysis to empower FAERS Adverse Event Mitigation
  • Coding Tips and Tricks
    • Convert the clinical SAS Datasets from RTF files
  • Data handling - Programmers are from Mars and Statisticians are from Venus
    • Cross study Analysis of SDTM Data Using R
    • Methods for Handling Concentration Valurs Below the Limit of Quantification in PK Studies
    • Janus Clinical and Nonclinical Loading: the most common issues identified from sponsor submissions
  • Data Standards and Governance
    • CRF Design for Data Standards
  • Data Visualisation
    • Benefits of Rapidly Growling Library of Clinically Relevant Visualisations Templates/Patterns
    • R2SAS R2SAS2PDF & SAS2SHINY: Seamless R and SAS
    • Unleashing Potential of Graphs for Ontology Trials
  • Regulatory
    • FDA CBER Data Standards Activity Update
    • Assuring Data Integrity and Data Quality in Sponsor Submissions
  • Review Use of Data Visualisations for Subject Level Data Review White Paper
    • Expanding poster into White Paper looking to present in November (EU Connect)
    • Team will be looking to send a survey out to the group in May
    • What tools have we missed? What features are you looking for within Data Visualisation?
  • Data Anomaly Detection
    • Still working towards schedule of presentations finalised

Next Meeting

  • Update from Best Practices for Interactive analyses for Decision Making and Submission team