WP01: Accomplishment of GCP, GMP, IMPD and ethical standards

Objectives

The main objective for work package WP01 is the support of the Sponsor-Investigator fulfilling GCP requirements, dealing with the responsibilities of the Sponsor such as Quality Assurance and Quality Control. Support in creating Standard Operating Procedures (SOPs), Working Instructions (WIs) and templates (e.g. study protocol) during the study preparation phase as well as during the conduct of the trial as well as monitoring and audits in Switzerland can be provided.

A further objective for work package WP01 is the support in the development of internet based online databases and support during the study.

Workpackage Description

The CTC will support the team of the Tissue Biology Research Unit (Partner 01a UZH-TBRU) and the University Children’s Hospital (Partner 01b UZH-UCH) of Zurich in the realization and the procedure of the clinical phase of the project with regard to GCP standards and Clinical Trial Management.