CRF for investigators
Our Clinical Research Facility (CRF) provides dedicated space, facilities and staff to support the conduct of early-phase, complex and high-risk experimental medicine studies. Our staff can support your research by helping to deliver clinical procedures, treatment administration, data collection, laboratory processing and study management.
The CRF is located within the Royal Free Hospital with ready access to a wide range of medical expertise and close to specialised services.
We are integrated with the following support services, institutes and national centres to ensure you have the support you need to conduct your research and develop new treatments. On the Royal Free Hospital site, we are co-located with:
- pathology
- radiology
- imaging, including three CT and four MRI scanners nuclear medicines and radio pharmacy
- clinical trials pharmacy
- Centre for Cell, Gene & Tissue Therapeutics
- UCL Institute for Liver and Digestive Health
- UCL Institute of Immunity & Transplantation
- Katherine Dormandy Haemophilia and Thrombosis Centre
- MRC/LifeArc national hub for gene therapy vector manufacture
We are active in the UK Clinical Research Facility Network (UKCRF Network) benefiting from close relationships with colleagues across the UK and the Republic of Ireland, sharing best practice and developing support tools for the delivery of clinical trials.
Early phase trial capability
The CRF is equipped to manage early phase clinical trials, mitigate risk and manage emergencies. It is fully integrated within the Royal Free Hospital with direct links to its acute and emergency care teams, including 24/7 emergency response and intensive care, is equipped with a resuscitation (crash) trolley and has treatment and intervention areas with wall mounted piped oxygen and suction.
CRF staff participate in regular skill development and emergency scenario training and there are extensive safety and quality assurance procedures and oversight mechanisms in place specifically for the delivery of early-phase clinical trials.
Ensuring quality
The CRF works to the standards laid out in ICH Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trials) Regulations, the Research Policy Framework for Health and Social Care and the UKCRF Network’s Framework for Conducting Highest Risk Phase I and Experimental Medicine Studies within NIHR Clinical Research Facilities and wider NHS acute trusts. These standards are embedded in the CRF’s Quality Management System (QMS). All users of the CRF are inducted into the CRF and the QMS.
Monitors, auditors and inspectors can request read-only access to the CRF’s policies and procedures while conducting their duties in the CRF and under the supervision of our quality assurance manager.
Flexible support according to your study needs
When undertaking research at our facility, investigators can choose from three different levels of support best suited to their study:
· Space provision: Where principal investigators (PI) run their study within the CRF with their own (non-CRF) research staff.
· Mixed model: Where PIs run their study within the CRF and select specific skills and/or services they require from the CRF to deliver their study.
· Full service: Where PIs lead the study within the CRF and CRF staff complete all protocol and administrative duties.
Regardless of the level of support we provide, all studies run within the CRF are delivered in accordance with our policies and procedures and under the clinical oversight of the CRF.
Our facilities
The CRF is located on the second floor of the Royal Free Hospital in Hampstead, North London. It is designed with safety, participant comfort and flexibility in mind, accommodating adult healthy volunteers and patients, and supportive of mobility and access needs. Participants have access to an open waiting area, kitchen, and accessible toilets.
We offer:
Spacious clinical areas for patient review and treatment
Generously sized clinic rooms and treatment bays are fully equipped to complete protocol activities from consent and screening to clinical procedures, exercise tests, administration of investigational products, serial sampling, and monitoring.
Flexible treatment areas are offered across a range of bays and side rooms, equipped with recliners (infusion chairs) or beds, to ensure patient comfort and safety during treatment or extended visits.
Regulated piped oxygen is available to all recliners and beds and the equipment provided includes digital blood pressure and O2 saturation machines, suction, ECG, fluid stands, infusion pumps, syringe drives and a resuscitation (crash) trolley.
Clinical trials pharmacy
Our in-house clinical trials pharmacy offers a comprehensive range of services including formulation, stability investigations, manufacturing, blinding, randomisation, packaging, labelling, storage, and distribution under its MIA (IMP) 11149 licence.
The pharmacy includes temperature controlled and monitored investigational product storage at ambient, cold (2°C to 8°C) and ultra-cold (-20°C and -80°C) ranges.
Sample handling and processing laboratory
The CRF includes a dedicated sample processing lab and storage facility including dual ambient/refrigerated centrifuges, 2°C-8°C fridges and -20°C and -80°C freezers.
We are also supported by a dedicated radiopharmacy for the manufacture and quality control of routine and research radiopharmaceuticals.
Patient accommodation for extended stays
For patients and participants who need to stay overnight, the adjacent research centre, the Pears Building, includes hotel style accommodation.
For participants requiring close monitoring we offer overnight inpatient beds in our Private Patient Unit (PPU) on the 12th floor of the hospital. All inpatient stays are staffed by a member of the study team and supported by a full complement of medical and nursing staff from the PPU.
For more information about patient accommodation, see here.
Applying to use the CRF
To undertake research in the CRF, a principal investigator (PI) with a Royal Free London NHS Foundation Trust contract (substantive or honorary) must be selected by the study sponsor.
The CRF operates an adoption committee which reviews each study for risk, capacity and capability and provides ongoing clinical oversight of the delivery of the study within the CRF.
The organisational confirmation of capacity and capability review for studies run in the CRF is completed by the RFL Research and Development (R&D) Office. All study costings and contracting are completed through this office. Clinical Trial Agreements (CTA) for studies run in the CRF are agreed between the study sponsor and the Royal Free London NHS Foundation Trust.
To request further information, please email the CRF at rf-tr.crf-studies@nhs.net or the R&D Office at rf.randd@nhs.net