Southampton NIHR Wellcome Trust CRF Registration form

This form must be completed by all investigators wishing to use the clinical research facility rooms and/or laboratory services. Investigators must also complete this form if they require CRF nurse support for clinical research studies running outside the facility. Please ensure that all the sections are completed fully and submit your form to .

Please ensure that you have contacted the R&D facilitators prior to submitting this form.

1. PROJECT DETAILS
Project title:
Short title: / RHM number:
Investigators details
Principal investigator
Name: / Email:
Address: / Telephone number:
Co- investigator
Name: / Email:
Address: / Telephone number:
Planned Start Date / Study Duration
Study Type
Phase I / Phase II / Phase III / Phase IV
First in Human / Dose escalation / Observational / Experimental medicine
Other (please specify):
For all Phase I studies, please contact the Senior QA Lead – Chris Blackwell ASAP
Risk Assessment
(see registration guidance notes) / Low / Medium / High
Medical Cover (see registration guidance notes)
Name: / Contact telephone number:

For all CTIMP studies please ensure that there is a 24hr emergency contact available

Study Recruitment
Recruitment target for this site / Competitive recruitment?
Healthy Volunteers / Patients
Study Visits details
How many treatment arms does your study have? / Please specify how many visits for each arm:
How many visit types? (i.e. screening, vaccination, follow up, telephone visit, etc) / Please specify duration for each visit type:
CRF / Location outside the CRF (please specify):
Day visits / Overnight stay
Night visits / Weekends
2. CRF RESOURCES
Clinical Research facility rooms required
Adult consulting room standard / Paediatric consulting room standard
Temperature controlled room / Paediatric treatment room
Medical gases / Paediatric cot or bed
Negative pressure / Paediatric Environmental chamber
Ophthalmology / Endoscopy suite
Humidity controlled / Pulmonary function room
Adult Infusion / single bed / Physiology Lab
High dependency bed / X-ray scanner
Low dependency bed / Nutrition kitchen
Adult Environmental chamber / Other (please specify)
CRF Laboratory support
Cell Culture Laboratory
CL3 Laboratory
Prep Laboratory
Centrifuges / Refrigerators (4 to 8C / Freezers (-20 or -80 C)
Microbiological safety cabinets / Tissue culture hoods / Incubators
Basic sample processing / PBMC isolation/other specific sample processing / Out of hours sample processing
How many samples per patient will the CRF laboratory receive?
(if study has more than one arm please specify how many samples for each)
Nursing support
CRF / Paediatric
BRU respiratory / Adult
BRU nutrition / R&D nursing team
Other (please specify)
What nursing skills do you require?
Coordinator support (for early phase and complex studies)
Regulatory submissions / Recruitment / Advertising
Investigator site file / Study Document
Guidelines for registering a research study with the Clinical Research Facility

The NIHR Wellcome Trust Clinical Research Facility is a multi-user facility for clinical research involving adults, children, healthy participants and patients. It is based within the Southampton Centre for Biomedical Research (SCBR) which comprises the CRF, the Southampton NIHR Biomedical Research Centre, the Southampton NIHR Respiratory Biomedical Research Unit and the Cancer Research UK-NIHR Experimental Cancer Medicine Centre. The University Hospital Southampton NHS Foundation Trust and the University of Southampton jointly manage the SCBR.

For more information about the CRF please visit the website:

http://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Trials-and-facilities/NIHRWellcome-Trust-Clinical-Research-Facility/Our-facility.aspx

Getting started

Please remember that we are here to help you to conduct your research as efficiently, rigorously and successfully as possible. Our aim is to guide you through the regulatory process in order to protect volunteers and staff within the frameworks of Good Clinical Practice, clinical governance, and the law. Please do ask us at any stage if information is not clear.

Early contact with the CRF, preferably during protocol development, is encouraged to establish how we can best facilitate your study. Early contact will also familiarise you with our requirements, clarify how the proposed study should proceed and ensure you are aware of any cost implications. All appropriate funding arrangements should be in place before submitting your registration. Please contact CRF Clinical Research Project Manager (#4989) to discuss your project.

It is essential that you contact the R&D department and meet with the R&D research facilitators prior to submitting your registration. The CRF and the R&D department work closely together to support your research study.

Risk Assessment

All investigators are asked to assess the element of risk associated with their studies in terms of clinical cover. With a number of concurrent risks the highest one determines the overall allocation to one of the risk categories indicated below. At times we may require further clarification and the final classification rests with the CRF.

a)  Low risk – Medical cover/PI available via phone, clinical cover in keeping with the responsibilities of a trained, registered nurse, e.g blood sampling, punch skin biopsy, measurement of body composition, cannulation

b) Medium risk – Clinical cover above and beyond that expected of a registered nurse, but which can be provided by a doctor within the hospital, who is available by bleep, e.g skin prick challenge, airway challenge, food challenge, oral glucose tolerance test, drug infusions, apheresis.

c) High risk – The level of intervention required by this study requires a physician to be present constantly in the same room, until the risk diminishes to level a) or b) above, e.g bronchoscopy, liver biopsy, hyperinsulinemic euglycemic clamp, exercise ECG in ‘at risk’ patients.

Phase I studies

Phase I studies which are to be conducted in the CRF must be formally approved by the Early Phase Safety Committee (EPSC) before taking place. The PI for a Phase I study must submit a completed EPSC Risk Assessment form (and associated contingency plan), and this will be reviewed by the EPSC. Written approval from the EPSC must be obtained prior to conducting a Phase I study in the CRF.

Medical Cover

If required (according to the registration risk assessment) medical cover must be pre-arranged (see section 1). It is the PI’s responsibility to ensure that the clinician who has been delegated to cover is available when necessary, and for the required period of time.

The contact number provided must be a direct number. The CRF cannot commit to providing medical cover for your study. For all CTIMP studies please ensure that there is a 24hr emergency contact available

Registration process

In order to use the CRF you will need to register your study with us. This helps us ensure that we can provide appropriate support, effectively plan and monitor the use of resources, and identify any future needs. Please note that although registration can start at any time, studies can only start in the CRF following UHS R&D approval.

Following acceptance of a study, one of the nursing or laboratory teams will organise an initial meeting with you. Each study is allocated to a named nurse, or to the laboratory manager, whose aim is to facilitate the research and be a point of contact.

3. NEW PROJECT REPORTER REVIEW FORM – FOR OFFICE USE ONLY
3.1 To be completed by Reporter Prior to New Projects Meeting
Protocol Review
Background of the study:
Aim of the study:
Methodology/Study Design:
Safety
Please outline potential safety issues for this study:
Drug Info / dosage / ARs:
For Phase I studies
EPSC Risk Assessment Reviewer notes:
EPSC Approval Date:
Study Delivery
Recruitment strategy: (how and by whom)
Study visit details (additional information):
Nursing: (how many hours, nurse duties, training, study intensity)
Study Intensity:
WTE:
WTE/A:
Reporter details / NAME:
DATE:
SIGNATURE:
3.2 To be completed at New Projects Meeting
Date discussed at New Projects Meeting
CRF requirements – Topics to be discussed by all representatives of key teams – reporter led.
Notes from each section will be recorded on the New Projects Meeting Record Sheet
1. Study Approvals
2. Study Documents
3. Facilities (storage, equipment)
4. Laboratory
5. QA
7. Pharmacy
8. Finance details (travel for staff and participants, inconvenience payment etc)
9. Other
Signed off by (chair) / NAME:
DATE:
SIGNATURE:

SCBR/FORMS/V1/076 1