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The PERS study Work packages WP05

WP05: E-Technology and Data-capture

Leader: UCL / P Santosh

  1. Developing and adding a section on sexual maturation and sexual side-effects and suicidal behaviour to the customized HealthTrackerTM.
  2. To customize the web-based HealthTrackerTM to host all the variables necessary for the risperidone long-term follow-up study.
  3. To ensure that the customized web-based HealthTrackerTM is Good Clinical Practice (GCP) compliant.
  4. To translate all the questionnaires and voice-files in the customized HealthTrackerTM suite into French, Italian, German, Spanish, Dutch, and Bengali.
  5. To assist and train all Centres to use the web-based customized HealthTrackerTM monitoring system.
  6. To setup HealthTrackerTM-generated Customisable E-mail Alerts, Reports and Reminders for the Centres.
  7. To achieve the ISO 27001 or equivalent level of security for web-based data acquisition and storage of the customized HealthTrackerTM in all its translated versions.
  8. To customize specific Bayesian algorithms to identify differences between risperidone-treated and untreated groups.
  9. To customize individual and group reporting about efficacy and side-effects for the purposes of the study.
  10. To serve as a possible platform for Post-marketing Surveillance and Pharmacovigilance (beyond 12 months).
  11. To develop a Risperidone-related Side-Effect Predictive Bayesian Algorithm.
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