Study design and regulatory staff support

Study design

The CRF Director and Head of Clinical Studies are able to provide advice on study design, including:

• Design and implementation of early phase clinical trials, in particular, first-time-in-human and mechanistic studies
• Selection of the most appropriate patient populations
• Development/validation of marker endpoints
• Expertise in access to experimental medicine tools

Regulatory support

The CRF focuses on science-driven, investigator-led, academic and commercially-sponsored studies, both single and multi-site. In addition to supporting the timely and cost-efficient implementation of studies, the CRF regulatory staff can help with the following:

• Submission to the CRF Protocol Review Board (PRB)
• Development of study-related documentation including protocols, participant information sheets, consent forms, GP letters and case report forms
• REC submissions
• MHRA applications
• R&D approval
• TMF/ISF set up and maintenance
• Project Management
• Data Management
• Monitoring of Imperial College London sponsored clinical trials

Clinical staff support

The CRF provides a team of qualified clinicians, research nurses and physician associates who provide support for studies if required. Each study is assigned a named contact within the nursing team who will ensure that studies are set up and performed to GCP standards.

Medical support

The CRF provides medical support during core working hours (9-5). Principal Investigators are required to identify medical cover outside these hours.

The CRF Director and Head of Clinical Studies provide the following medical support:

• Senior medical advice and support for all clinical studies in healthy volunteers and patients
• Agree the level of medical cover required for all studies with the PI, ensuring that they are carried out safely and in compliance with protocols
• Review, approve and sign-off clinical incidents within the CRF

The CRF employs Trust doctors and physician associates who provide the following support where agreed at PRB:

• Medical assessment and clinical cover
• Assist in dosing of study medication,
• Perform clinical procedures as appropriate to the assigned study,
• Assess adverse events and manage medical emergencies
• GCP and ALS trained

Nursing support

The CRF has an establishment of 15 research nurses who provide clinical care and research activities for all CRF studies. The research nurses work closely with researchers to ensure that the studies are conducted safely and to the highest standards. All of the nurses are clinically experienced and GCP trained.
Our nurses are able to provide the following specialist activities:

• 24-hour ambulatory ECG
• SACT administration
• Euglycaemic clamp studies
• Non-invasive haemodynamic monitoring
• Pulse oximetry
• Phlebotomy
• Pharmacokinetic sampling

Reception and administration support

The CRF reception is manned from 8:00 to 5:00 Monday to Friday. Reception staff support the following activities:

• Schedule participant appointments
• Book participants into the facility
• Arrange study-specific taxi accounts and manage patient expenses where applicable
• Manage general enquiries
• Administration
• Healthy Volunteer Database

The Imperial CRF hosts a Healthy Volunteer Database, providing a panel of pre-screened healthy volunteers who have demonstrated an interest in volunteering in clinical research studies. Panel members have been recruited into CRF studies in a wide range of fields including dietetics, imaging, neurology, geriatrics, fertility, addiction and obesity research. This resource is available for studies registered with the Imperial CRF.