Study design and CRF staff support

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

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

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.

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

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

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.

The CRF has a PPIE manager and over 30 members of the public with or without lived experience ready to provide public involvement and engagement guidance and support.

If you would like further information on PPIE or would like to seek advice on your PPIE plans for your research, please contact Aime Palomeras (aime.palomeras@nhs.net) 

What is public involvement?

NIHR defines public involvement as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. This includes, for example, patients, carers, and members of the public working with us to prioritize research, offering advice as members of a project steering group, commenting on and developing research materials, and undertaking interviews with research participants.

Find out more - Public involvement in research | NIHR

What is public engagement?

Unlike involvement which is a collaborative way of working with the public, engagement is a one-way approach where information and knowledge about research is provided to, or shared with the wider public. This includes a range of activities such as science festivals and fairs, schools open events media awareness and many more.

Find out more - The Centre for Societal Engagement at Imperial | Be inspired | Imperial College London

Useful resources for Researchers:

• Guidance for researchers new to public involvement - Briefing notes for researchers - public involvement in NHS, health and social care research | NIHR
• A framework for what good public involvement in research looks like and a tool to help people and organisations identify what they are doing well, and what needs improving - UK Standards for Public Involvement - The UK Standards
• A values based approach for public involvement i.e. budgeting, reaching public members and disseminating -  www.publicinvolvement.co.uk 
• For PPI Training, Guide to Public Involvement/Co-Production and PPI support for researchers affiliated with NIHR Imperial BRC research - Public Involvement Resource Hub | Faculty of Medicine | Imperial College London) 
• Guidance on PPI and qualitative research methods in health and social care research with an emphasis on how they differ - RDS_Guide_to_PPI.pdf