Observational study to collect data via a wearable device

  • Research type

    Research Study

  • Full title

    An observational study to collect exploratory data via a wearable device in subjects participating in a human challenge study

  • IRAS ID

    291795

  • Contact name

    Robin Rogiers

  • Contact email

    r.rogiers@hvivo.com

  • Sponsor organisation

    hVIVO Services Limited

  • Duration of Study in the UK

    years, months, days

  • Research summary

    Wearables are more and more being used in clinical trials and have shown the potential to significantly impact the data available for clinical trials and medical researchers in numerous ways. While the quality and efficacy of these devices can vary, the sensor technologies in these devices have evolved to meet the needs of many clinical research endeavors.

    This exploratory study aims to gather medically relevant data via a wearable device in subjects participating in a human challenge trial. The data will be used for further finetuning of the human challenge model, in order to further finetune the model increase its performance over time. The collected date will in no way be used to assess safety or efficacy data.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    20/PR/0752

  • Date of REC Opinion

    14 Jan 2021

  • REC opinion

    Further Information Favourable Opinion