WP02 - Set up framework

Objectives

  • To develop an effective scientific management framework (coordination, managerial and administrative tasks to facilitate the clinical trial) which will ensure the correct progress of the project towards its planned objectives
  • To facilitate the foundation for study participation at each individual centre (protocol, safety, legal, ethical issues & pharmacy issues)

Workpackage Description

Work package 2 will involve the following tasks:

Task 1: Development & finalisation of trial protocol and standard operating procedures

Task 2: Creation of study documents

Task 3: Final selection of centres for the study

Task 4: Development of monitoring network for NILVAD in Europe

Task 5: Coordination of regulatory and ethical approvals in different European countries

Task 6: Drug Procurement, packaging & distribution

Task 7: Establishment of the Scientific Advisory Board (SAB)

Task 8: Establishment of the Data Monitoring and Safety Board (DMSB)

WP Leader

King's College London (Prof. Robert Howard)