for Committees and Working Groups

Enroll-HD Governance


The governance of Enroll-HD is overseen by a Steering Committee, which has overall responsibility for the study.

The oversight and management of Enroll-HD is handled by the following committees. In the future, meeting reports and information about the activities of each of the committees will be available here.

Steering Committee

The Enroll-HD Steering Committee has overall responsibility for the study:

  • Scientific direction
  • Maintaining scientific integrity
  • Achieving the study aims
  • Promoting ethical practices and data privacy
  • Monitoring data distribution
  • Resolving conflicts
  • Ensuring safety of the research participants

Chair: G. Bernhard Landwehrmeyer, MD, University of Ulm · Clinic of Neurology, Ulm, Germany

Members: Claudia Perandones, David Craufurd, Jody Corey-Bloom, Cristina Sampaio, Jean-Marc Burgunder, Joaquim Ferreira, Bernhard Landwehrmeyer, Francisco Cardoso, Martha Nance, Francis Walker, Mark Guttman

 

Data Safety Monitoring Committee

  • Review all reportable events
  • Address CAG discrepancies between study research genotyping and local CAG results
  • Discern any issues of overall safety that are of concern
  • Monitor the CAG testing procedures to ensure high quality

Chair: Arvid Heiberg, MD

Members: Susan Fox, MD; Daniel Weintraub, MD; Sandrine Andrieu, MD, PhD; Ken Cheung, PhD

Care Improvement Committee

  • Responsible for strategies aimed at improving clinical care through evidence-based clinical research
  • Outcomes research, standards of care and quality improvement initiatives

Co-Chairs: Martha Nance, Mark Guttman

Members: Zofia Miedzybrodzka, RIchard Roxburgh, Daniela Rae, Erika Bjorklund, Mary Edmondson, Jan Frich, LaVonne Goodman, Eugene Nelson

 

Scientific Planning Committee

  • Sets scientific strategy and priorities
  • Recommends centrally activated data analysis
  • Reviews applications for studies that seek to use the Enroll-HD platform and decides which should go forward

Co-chairs: Karen Anderson, MD, Georgetown University Medical Center, Washington DC, USA and Julie Stout, PhD, Monash University, Melbourne, Australia

Members: Erik van Duijn, Hugh Rickards, James Gusella, Nellie Georgiou-Karistianis, Blair Leavitt, Anne Rosser, Cheryl Fitzer-Attas, Ray Truant, Jeff Carroll

Scientific Publication Review Committee

  • Oversees data sharing processes and publication policy
  • Reviews and approves requests for data and bio-specimens
  • Provides expert advice on proposals as requested by researchers

Chair: Joel Perlmutter, MD, Washington University School of Medicine, St Louis, Missouri, USA

Members: Andy Feigin, Don Higgins, Anne-Catherine Bachoud-Levi, Ralf Reilmann, Oliver Quarrell, Sarah Camargos, Richard Roxburgh, Martin Delatycki, Doug Langbehn, Claudia Perandones

Operations Committee

  • Provides operational support and leadership for the study
  • Data quality monitoring
  • Manages data and sample sharing processes
  • Tracks and reports study metrics
  • Determines feasibility of studies that want to use the Enroll-HD platform, and reports to governance committees 

Chair: Joe Giuliano, CHDI (Princeton, USA)

Working Groups

Communications

The primary function of the Communications Working Group is to manage the overall communication around the Enroll-HD study. This includes, but is not limited to, developing a new Enroll-HD website, logos, e-newsletters, etc. The Working Group will survey the major stakeholder groups involved in Enroll-HD and determine appropriate communication strategies that ensure an effective and efficient sharing of information about the new study.

Data Management

The CRO partner and their assigned data management experts will have the primary responsibility for providing a data migration plan template, writing the data migration plan, managing the migration activities between CTCC and 2MT, and will work closely with the Data Management Working Group to obtain advice, support and coordination.The primary responsibility of the Data Management Working Group is to ensure that the Enroll-HD database and data will be available to go live on the date defined by the Executive Committee. This includes either the successful migration of data from COHORT and REGISTRY to the Enroll-HD database or a detailed plan that can be implemented to migrate the data at a later date. This plan should involve minimal risk and/or disturbance to the Enroll-HD database.

Responsibilities
  • Provide assistance, advice and support to the CRO partner
  • Provide liaison support between the CRO, the University of Rochester CTCC and 2MT
  • Review and comment on key documents and plans produced by the CRO and 2MT
  • Ensure flexible database structure
  • Ensure ability to incorporate data from other sources as appropriate

European Transition

The European Transition team is responsible for migrating the Registry Sites into Enroll-HD which involves managing and delivering on tasks that occur before, during and after a site’s transition.  Activities include setting up ethics approvals/notifications (and any additional governance-related matters), executing contracts, training of site staff, and ensuring the successful migration of Registry data into the Enroll-HD EDC.