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WP2 –
Trial Preparation

WP2 – Trial Preparation

The objective of this WP is to prepare and coordinate the clinical trial and monitor progress of preparation as well as providing operational support to trial centres in all countries.

The specific objectives of this WP are to:

  • finalize the clinical study protocol and essential study documentation.
  • obtain regulatory and ethical approval in all study countries.
  • ensure that drug management will be performed in accordance with European rules.
  • plan monitoring activities.
  • define strategies for a centralised safety management and an independent DSMB.
  • provide a clear, validated methodology for data management and outcome analysis
  • perform the final selection of European expert centres for patient recruitment

The clinical trial infrastructure will cover the following partners:
The KKS Heidelberg of UK-HD (as lead CTU) in cooperation with ECRIN will provide operational services to support EKUT in designing and planning the multinational trial according to current international standards and laws. The trial will be conducted in Belgium, the Czech Republic, Finland, Germany, France, Spain, Sweden and Switzerland. The lead CTU will be responsible for the operational services within Germany and for the overall activities for the whole study.
Each national ECRIN partner will be selected by ECRIN in close cooperation with the lead CTU (KKS Heidelberg) and the sponsor according to the investigational site, their skills/expertise and the availability of specific study resources and will provide services (regulatory submissions as well as clinical monitoring, national project management) on behalf of and as authorized by the Sponsor.
The EKUT is responsible for the overall study and will implement an appropriate project structure enabling its partners to comply with the project needs and regulations.
All partners involved in the conduct of the RCT (i.e. UZL, UHB, HUS, CHSA, VHIR, UGOT and CHUV) will support EKUT, KKS of UK-HD and ECRIN with trial preparations in their respective countries.

Task 2.1

Development and Finalization of the Clinical Trial Protocol and the Essential Study Documentation

Task 2.2

Regulatory and Ethical Approval and Follow-Up

Task 2.3

Monitoring Conception of the Clinical Trial

Task 2.4

Pharmacovigilance Conception

Task 2.5

The Independent DSMB

Task 2.6

Statistical Planning and Data Base Setup

Task 2.7

Perform the Final Selection of European Expert Centres for Patient Recruitment

Task 2.8

Ethics management