Treatment of Ulcerative Colitis patients: Retrospective chart review

  • Research type

    Research Database

  • IRAS ID

    288918

  • Contact name

    Evie Merinopoulou

  • Contact email

    evie.merinopoulou@cytel.com

  • Research summary

    Electronic database based on medical records/charts (Multi-centric study on UC patients)

  • REC name

    North West - Haydock Research Ethics Committee

  • REC reference

    20/NW/0398

  • Date of REC Opinion

    16 Oct 2020

  • REC opinion

    Unfavourable Opinion

  • Data collection arrangements

    The study requires that your patient characteristics and disease data to be collected on a questionnaire and/or in an electronic database. These anonymized information are collected, stored and evaluated confidentially. Only your doctor will have access to your treatment data. In this context, information from your patient file is used and data from your past visits to the doctor are documented. It should be expressly noted that your personal data (such as name or address) will not be known to the researcher team. At no time will any data be published that may be used to determine your identity. After completion of the study and evaluation of the results (no later than end of 2030) all data will be permanently deleted.

  • Research programme

    Within this study, a retrospective survey of medical records of patients with ulcerative colitis is to be carried out. This means that we only want to record how you have been treated so far. In this study we in no way change the medical care you receive. Also, no new drugs are tested. The study not even refers to the treatment you receive from today onwards, it only deals with the past. This study is carried out throughout Germany and the United Kingdom in approximately 40 centers. Thus, total of about 450 patients will be included.

  • Research database title

    Electronic database based on medical records/charts (Multi-centric study on UC patients)

  • Establishment organisation

    Cytel Statistical Services and Software UK Limited

  • Establishment organisation address

    Hamilton House

    Mabledon Place- London

    Greater London

    WC1H 9BB