Application to use Addenbrooke’s Clinical Research Centre

Wellcome Trust Clinical Research Facility and Clinical Investigation Ward

Applicant Details

Name / Box No / Ext No
Job Title / Trust Contract Status Substantive / Honorary
Research team memberscontract status with Addenbrooke’s NHS Trust
Name / Job Title / Trust / Honorary / Medical

Project Details

Protocol Title
Study Summary
Project type please circle
Experimental / Observational / Epidemiological / Screening
Other please state
Clinical Trial / Phase I / Phase II / Phase III / Phase IV
Specialty / Disease area
Principal Investigator / Ext no
Job Title / Box no
Contract status
Please circle / Trust / Honorary / Honorary Research / Medical
REC No / Approval date
Trust R&D Approval / Date
Project Funding Source

Sponsor

Value of GrantIfapplicable
Purpose /use of funds
Funding Organisation
Funding Source
Please circle / UK based charity / charitable Trust / UK Health / hospital authority / Research Council
Local fund / own account / Commercial / NIHR BRC
Commercial Studies
Please circle / Investigator-led / Yes / no
Industry-led (contract research) / Yes / no
ACRC costs agreed / Yes / no
Session Planning
Expected start date / End Date
Number of participants to be recruited / Participants / session
Will participants be recruited from Non-EU Countries yes /no
Preferred Days / Times space is allocated on a first come first serve basis
Sessions
/ 08.00-13.00 / 14.00 -17.00 / 17.00- 21.30 / 22.00- 08.00
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Facilities Required
Inpatient bed / Day case bed
Outpatient couch/room / Investigation room
Body composition* / Calorimeter*
Audiology test room* / Endoscopy suite*
DEXA* / Overnight stay
Dietetic advice / Special Dietplease specify
Other please specify
* charges may apply to use these facilities please contact Clinical Manager for details
Study Interventions
Intervention / Frequency / By ACRC staff / By research team
Observations
Sampling
Sample Processing
Other study related activity likely to impact on nursing time please specify

Drug administration

/ Frequency / By ACRC staff / By research staff
Please specify
Isnursing care to be shared between ACRC staff + research team yes / no
Pleasespecify
Does the study involve the use of Ionising Radiation yes / no
If yes please specify
Medical Cover
On site Medical Cover for participants
Name
Job Title
Department / Ext no / Bleep Number
Out of hours and emergency arrangements if different from above
Name
Job Title
Department / Ext no / Bleep number
Does this study required 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 Addenbrooke’s NHS Trust and ACRC
I agree to charges for diagnostic and laboratory investigations being made to the Principal Investigator
I confirm acceptance of the Trust Policy governing Intellectual Property Rights
I agree that the research team nurses when working on the ACRC are accountable to the Clinical Manager
I confirm all study staff involved in the study have: Trust, Honorary or Honorary Research contracts with Addenbrooke’s NHS Trust
I confirm that responsibility for indemnity against negligent harm is held by my employing Trust
Documents to be included with this application
Study Protocol including date & version
Patient Information sheet including date & version
Copy of REC application and any relevant parts eg Part C site specific assessment
Copy of approval (favourable opinion) letter from REC
Copy of Trust R&D approval letter
Applicant’s Signature / Date
Name

Permission to use ACRC facilities is granted for one year and reviewed annually thereafter.

A renewal letter will be sent 2 months prior to the annual review date, failure to reply will mean the study is no longer eligible to use the facilities.

Please return toCaroline Saunders, Clinical Manager

Wellcome Trust Clinical Research Facility, Box 127 Addenbrooke’s Hospital

Hills Road

CambridgeCB2 2QQ

Telephone01223 596057

ACRC Application Form Version 15 (July 2007) 1