Comparison of ADR reports received via Yellow Card app with casenotes

  • Research type

    Research Study

  • Full title

    WEB-RADR - Recognising Adverse Drug Reactions WP4 Study - Comparison of Adverse Drug Reaction (ADR) reports received via Yellow Card mobile app with case notes

  • IRAS ID

    190376

  • Contact name

    Alastair Sutcliffe

  • Contact email

    a.sutcliffe@ucl.ac.uk

  • Sponsor organisation

    The UCL Institute of Child Health

  • Clinicaltrials.gov Identifier

    14PP23, WEB-RADR Recognising Adverse Drug Reactions

  • Duration of Study in the UK

    1 years, 7 months, 31 days

  • Research summary

    At the moment reporting of adverse drug reactions by hospital personnel is mainly done by paper or through the web-based form. The aim of creating a new reporting tool, the app, is to increase reporting and to make reporting easy with the hope of gathering new information about ADRs which will help to evaluate the benefit-harm of drugs. The first version of the Yellow Card mobile app was launched recently in July 2015. However, it is important to make sure that the reports received through the app capture the clinical data accurately.
    This study will be aimed at investigating the accuracy and trustworthiness of reports received through the app. The live App data covers the whole of the UK. And depending on workload the study team will investigate all reports for which the reporter agrees to supply extra information from patient case notes.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    16/YH/0072

  • Date of REC Opinion

    15 Feb 2016

  • REC opinion

    Favourable Opinion