Aim
Our main aim in relation to clinical trials management is to build the methodology to design and conduct academically initiated transnational prospective clinical trials in stem cell transplantation in Europe, in accordance with the EU Directive on Clinical Trials and the standards of Good Clinical Practice (GCP).
Description of work
| Task 1: |
To harness Industry knowledge and experience in clinical trials management |
| Task 2: |
To develop a review process for the approval and prioritisation of clinical trials which comply with standards of GCP |
| Task 3: |
To produce Standard Operating Procedures (SOP’s) for the conduct of clinical studies |
| Task 4: |
To conduct clinical trials following the review process and SOPs which are put in place |
For a progress report on the activities and deliverables related to the clinical trials work package visit work package 1.