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WP3 –
Performance of Clinical Trial Logistic, Monitoring and Quality Assurance

The main objective of this WP is to conduct a European, investigator-initiated, multicentre clinical trial to assess the effects of NBHO in IS. The specific objectives of this WP are to:

  1. organise investigator training workshops (to standardise the administration of study treatment and the scoring of tests and rating instruments).
  2. set up sites and implement measures to ensure recruitment.
  3. provide advice and support to clinical sites throughout the duration of the study.
  4. complete the clinical trial on time.

In close cooperation with the ECRIN (the WP-Leader), UK-HD (KKS Heidelberg), EKUT and partners with expertise in IS will conduct this WP. They will be responsible for facilitating and ensuring smooth performance of the study and providing the required investigational support to clinical sites.
The involvement of top international experts in IS and the national networks for clinical research in IS led by our consortium partners (namely UZL, UHB, HUS, CHSA, VHIR, UGOT and CHUV together with the SAB) guarantees the support required to implement, perform and analyse the results of the RCT. A first meeting of the consortium including the SAB will be held at the 2nd annual conference of the European Stroke Organisation in Barcelona (Mai 10th-12th 2016).

The centres will be responsible for recruitment, safety assessments, efficacy assessments, outcome measures, performance of the study (in accordance with a standardized protocol, GCP and applicable regulations), data collection and responses to data queries from the sponsor.

Task 3.1

Non-clinical Project Management and Regulatory Affairs

Task 3.2

Pharmacovigilance During the Clinical Trial

Task 3.3

Quality Management During the Clinical Trial – Central and On Site Monitoring

Task 3.4

Organize Rater-Training Workshops for Standardising the Administration and Scoring of Tests and Rating Instruments

Task 3.5

Provide Ongoing Support to Clinical Sites

Task 3.6

Interim Analysis – Completion of the Clinical Trial