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Clinical studies
M03 Developing strategies for global compliance to data privacy and data protection in an observational non-interventional study of huntington's disease
  1. O Handley1,
  2. J Giuliano2
  1. 1University College London, Institute of Neurology, Queen Square, Institute of Neurology, London, UK
  2. 2CHDI Foundation, USA


Introduction Enroll-HD is an observational non-interventional global study of Huntington's disease. The study aims to improve understanding of the disease's characteristics, develop evidence-based guidelines to inform clinical decision making and improve health outcomes, and establish a platform to support the design and conduct of clinical trials. To achieve these goals, de-identified data and bio-specimens collected in the course of the study will be made available through a web-based platform to qualified researchers. Enroll-HD will cover the following regions: North America, Europe, Latin America and Asia Pacific. Data Protection Law varies from country to country and one critical aspect in the planning of this global study has been to establish methods for assessing, managing and implementing strategies to ensure compliance whilst maintaining the integrity of the study.

Methods A series of methods are being used to ensure global compliance to data privacy and data protection. (1) identify and understand the Data Protection Laws that apply in each country and develop a study infrastructure that complies in a global capacity, (2) establish study governance that ensures accountability and allows data only to be shared with appropriately qualified researchers, (3) apply and obtain all required Data Protection approvals, 4) develop monitoring plans to verify Data Protection compliance with reference to applicable laws.

Results/discussion The authors will present the plans and implementation of the following critical elements that impact on compliance with data protection laws:

1) IT infrastructure

2) Understanding and reconciling regional requirements

3) Putting together successful applications for review by data protection governing bodies

4) Developing a robust study infrastructure with clear lines of responsibility and accountability for compliance issues with independent oversight

In the near future these plans will be tested during the regulatory review and approval process and their success will be measured.

  • Data protection
  • observational
  • governance

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