UCD School of Medicine & Medical Science : Our Team & Facilities

The UCD CRC has a significant track record in supporting clinical trials. From single site, to multi national, from investigator-led to industry-sponsored, from Phase 2a to Phase 4, we have undertaken over 150 clinical trials and have significant experience and knowledge of both the regulatory and the operational environment.

In addition to clinical trials, we also provide supports for non-interventional studies including sample collections. We recognise that all clinical trials are different and so provide tiered supports so we can tailor supports required to the needs of the investigator. These supports include:

State-of-the-art facilities within major acute hospitals for high quality clinical research
An environment which is:
Supportive to clinicians to undertake hypothesis-driven investigator-led clinical studies
Recognised by regulators, pharmaceutical companies and clinical research organisations as being professional, of the highest quality and suitable for the conduct of clinical trials.
Attractive to patients and encourages participation in clinical research and trials by providing excellent clinical care and access to latest clinical interventions
- A cohort of professional and experienced research scientists, data managers and clinical research nursesthat can ensure studies are conducted and managed to the highest levels
- Complete study management, oversight and sponsorship

Staff

The UCD CRC has a dedicated team of expert staff including research nurses, research assistants, laboratory staff and others that are available to support a clinical trial. Importantly, all our staff are expert trained and operate under regularly reviewed Standard Operating Procedures, ensuring compliance with all ICH-GCP and other regulatory/statutory requirements.

Facilities

The CRC has a suite of clinical consulting rooms, as well as procedure and recovery rooms supporting moderately invasive procedures such as arthroscopy. There is also access to a research dedicated DEXA scanner located at CRC MMUH.

Dedicated waiting areas
Fully equipped consultation rooms
Clinical suites for minor procedures
Laboratory services for processing of samples

The clinical trial facilities are operated under both the CRC and also the hospital governance systems, with specific CRC Standard Operating Procedures designed to ensure international best practice under ICH-GCP, and to ensure that patients’ rights and safety are at the forefront of all activities undertaken.

CRC Quality Management

UCD CRC has a Quality Management System for the conduct of clinical trials. This is divided into 3 main areas:

1. UCD CRC Personnel Induction and Training

All personnel starting at UCD CRC undergo a staff induction process which encompasses orientation and training in all areas within the CRC and responsibilities specific for staffs’ job role. Induction and training is documented and maintained on an ongoing basis.

2. Personnel Responsibilities & Compliance

Before being initiated onto any clinical research study all staff must have signed off acknowledgement and compliance to all Standard Operating Procedures (SOPs) established in the CRC. The SOPs are specific to all clinical, laboratory, regulatory and quality aspects vital in the conduct of a clinical trial at the CRC.

3. Study Conduct and Integrity

Before any clinical studies can commence, there is an internal application review and approval process for any entity wishing to conduct clinical research on site, as well as an independent review and approval from both the Ethics Committee and the Regulating Authority for Ireland – the HPRA. Internally within the CRC as well, there is the function to monitor and carry out audits on CRC systems and research activities to ensure compliance with SOPs and continual improvement of the quality of the research being conducted.