Cambridge Clinical Research Centre

Cambridge Clinical Research Centre

Application Form

Applicant Details

Name / Email / Ext or Bleep
Post / Box / CUHFT Contract Status Substantive / Honorary

Principal Investigator

Name / Email / Ext or Bleep
Post / Box / CUHFT Contract Status Substantive / Honorary

Research Team including trainees

Name / Post / Substantive / Honorary / Medical

Project Details

Acronym | Short Title / Version / Date
Full Protocol Title
Explain why you need access to Cambridge Clinical Research Centre facilities
Protocol Peer Review undertaken by: name of organisatione.g. University, Charity, Pharma, Other
NRES No / Approval Date / R&D No / Approval Date
UKCRN No
if applicable / known / EudraCT No if relevant
Is this study supported by NIHR? please specify / Biomedical Research Centre / Biomedical Research Unit / NIHR BioResource / Translational Research Partnership / Collaboration

Project Type please select:

Experimental Medicine / Epidemiological / Observational / Otherspecify
Phase 0 / Phase I / Phase IIa / Phase IIb / Phase III / Phase IV
Other Clinical Trial / Feasibility / Pilot / Interventional specify
If your project is not experimental medicine or early phase i.e. Phase IIb | III | IV please select option(s) below
study requires specialist facilities | support | equipment / nested experimental medicine study

Project Funding Source

Name of Main Funding Organisation >50%
Category
please select / Industry Contract / Industry Collaborative / Industry Investigator initiated / supported
Research Charity / Research Council / Other non-commercial e.g. EU / DH/NIHR
For DH/NIHR
please select / EME / HS&DR / HTA / i4i / PGfAR / PHR / RfPB / Other / NIHR Research Schools / Other NIHR
For Industry
select all that apply / Pharma / Biotech / Medtech/device / Diagnostic / Non life science / CRO / SME
Study Sponsor / Lead Centre for study
NON COMMERCIAL STUDIES Does this study receive industry support? / No  Yes  Drugs / Kit / Grant

Session Planning

Start Date / End Date / Non-EU Participants / Y/N / Country
Study recruitment target / Site recruitment target / Visits per participant

Session Request Facilities Required

Sessions

/ 08.00-13.00 / 14.00-17.00 / 17.00-21.30 / 22.00-08.00 / Please select / Charges apply*
Monday / Inpatient Bed / Audiology Room*
Tuesday / Investigation Room / Calorimeter*
Wednesday / Exercise Test Room / Body composition*
Thursday / Day Case Bed / DEXA*
Friday / Outpatient Room / Endoscopy suite*
Saturday / Ophthalmology Room / Exercise testing
Sunday / Dietetics / Sample handling

Study Interventions

Visit types / For CTIMPs please specify cycle(s), week(s),day(s), / CCRC Team / Study Team
Screening
Baseline
Dosing
PK sampling
Follow-up
Other interventions / visit types please specify
Does the study involve the use of Ionising Radiation? yes / no If yes please specify

Medical Cover

On site Medical Cover for participants will be provided by:
Name / Email
Job Title
Department / Ext no / Bleep Number
Out of hours and emergency arrangements: if different from above
Name / Email
Job Title
Department / Ext no / Bleep number
Does this study require overnight medical cover to be present on the unit? yes / no If yes please specify below
Name / Job Title
Department / Bleep Number

Lead Investigator obligations to CUH NHS Trust and CCRC

I agree to charges for diagnostic and laboratory investigations being made to the Principal Investigator
I agree that research team nurses when working on the CCRC are accountable to the Nurse Managers
I confirm all study staff involved in the study have: Trust, Honorary or Honorary Research contracts with CUHFT
I confirm that responsibility for indemnity against negligent harm is held by my employing Trust
I agree to acknowledge the use of the facilities in any publications and or publicity arising from the study
I agree that members of my team will comply with local CCRC policies and procedures

Document Checklist please submit with yourthis application

Documents to be included / Y | N | NA / Comments
Final version of Protocol
Final version Participant Information Sheet(s)
Final version of Consent Form(s)
Copy of IRAS Form
Copy of NHS REC approval letter
Copy of NHS R&D approval letter
Copy of SSI
Investigators Brochure
Lab manual
Any other relevant documents Patient diaries | questionnaires | adverts
Applicant’s Signature / Date

Please send completed application form and documents to:

OR by Email or Post to: Lindsay Carr, Clinical Trial and Study Application Manager

Cambridge Clinical Research Facility, Box 411, Addenbrooke’s Hospital, Hills Road, Cambridge, CB2 0QQ

For advice: Telephone:01223 256754

Access to CCRC facilities is granted for 1 year and reviewed annually thereafter. Allocation of space is subject to availability.

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager
This document is reviewed and updated in line with emerging evidence or local requirements at least every three years
CCRC/FRM001 Associated with CCRC/SOP002 / Version 13 / Approved: 28/11/2017 / Page 1 of