We are the Haematology Clinical Trials Team which is part of the Haematology Clinical Practice within the Leeds Teaching Hospitals Trust. Currently spread across 5 sites in Leeds, as of January 2008 we will be based at the Bexley Wing, St James Hospital.
The team consists of Consultants, Specialist Registrars, Research Nurses, Pharmacists, Co-ordinators and Assistants. We play a vital role working collaboratively as part of a multi-disciplinary team, involved in the planning, implementing, delivery and evaluation of care to patients participating in clinical trials.
We are an integrated team, responsible and accountable within the current Institute of Clinical Harmonisation Good Clinical Practice standards as well as working to local policies and procedures. Good Clinical Practice GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects (ICH Guideline for GCP 2006).
The Consultant Haematologists perform the role of the Chief or Principal Investigator with the responsibility for the conduct of the individual trials. With the other members of the medical team, often the Co-Investigators and Specialist Registrars, they provide support and advice by performing trial related procedures.
The Haematology Clinical Trials Nurses act as advocates for patients and related others participating in the clinical trial. Working within NMC Guidelines and trial protocol the nurses perform the clinical procedures required including the monitoring of patients and their progress.
The Clinical Trial Coordination Team are actively involved in trial set up and day to day management ensuring the trials are correctly approved by the appropriate governing bodies including R&D and Ethics Committees.
The Pharmacists are an important part of the clinical trials supporting the whole process.
Adhering to the guidelines of a trial protocol, we are developing and maintaining a high standard of care, providing clinical/administrative leadership, direction and supervision as part of the multidisciplinary team. An audit trail is necessary to uphold Good Clinical Practice guidelines which are supported by standard operating procedures (SOP) within the team.
We are highly trained and dedicated staff who recognise the patients' rights to independence, choice, privacy and dignity. We are committed to promoting a high standard of care.