Application Form

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Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
Manchester Clinical Research Facility
Study Application Form
Please complete this form as fully as possible: contact us (rsm@wtcrf.nhs.uk) if you need any assistance.
Project Title:
Short Title:
Principal Investigator Details
E-mail address:
Name:
Postal address:
Employer:
Telephone number:
All members of the research team working at the Facility must be listed on the SSI.
Primary Day Contact
Best day-to-day contact, e.g. clinical fellow, research nurse, research coordinator, secretary…
Name:
E-mail address:
Telephone number:
Study Timeline considerations
Please detail recruitment start and end
dates, and projected date for end of followup (i.e., end-of-study date):
If study design means that there will be less
than seven days from participant approach
to appointment, please highlight this.
Participants
Source of recruits:
Participant age range:
Number of participants to be seen at CRF:
Are you aware of any other studies running within this field
which might affect recruitment?
NIHR/WT Manchester CRF Application Form
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Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
Value Added by Use of MCRF:
Specialist clinical support
One stop shop for participants
Environment
Specialist equipment
Administration/Appointments support
Other
Please explain how using the Facilities will improve delivery of the study:
Study Type
First Area
Second Area
Second Area
First Area
Second Area
First Area
Phase I
Please select the most appropriate project type:
(If 'Other', please give
details)
Please select the two most appropriate principal research areas:
Blood
Infection
Oral & Gastrointestinal
Cancer
Inflammatory & Immune System
Other
Cardiovascular
Injuries & Accidents
Renal & Urogenital
Congenital Disorders
Mental Health
Reproductive Health & Childbirth
Ear
Metabolic & Endocrine
Respiratory
Eye
Musculoskeletal
Skin
Generic Health
Neurological
Stroke
NIHR/WT Manchester CRF Application Form
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The user of this document is responsible for referring to Q-Pulse for the current version
Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
Main Funding Organization:*
Please select the category of the main
funding organization for this study:
Please give the name of the main funding organization, and the total amount awarded:
Name:
Award Amount:
Secondary Funding Organization:
Please select the category of the second
funding organization for this study, if there is
n/a
one:
Please give the name of the second funding organization, and the total amount awarded:
Name:
Award Amount:
Grant Administrating Organization:
Please select organization which will
University of Manchester
administer the research grant: *
Please give the grant reference (if known),
and details of organization if ‘Other’:
Research Governance Sponsor:
Please give details of the organization acting
as research governance sponsor:
Has research governance sponsorship been
confirmed?
Has the study been adopted by a study
network?
(If yes, please give details of network, and whether the adoption is in
application, or has been confirmed.)
Eg: Cancer RN, CCRN, DeNDRoN, Diabetes RN, MCRN (or
PNMR), Mental Health RN, Primary Care RN, Stroke RN.
Are any research fellowships, or Masters or
PhD students, attached to or supported by
the study?
(If yes, please give details.)
NIHR/WT Manchester CRF Application Form
Page 3 of 6
Free to Print
The user of this document is responsible for referring to Q-Pulse for the current version
Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
MCRF Resources
Overview
Please briefly outline your requirements for MCRF support:
Clear explanation of resource needs is crucial for assessing applications.
Please note that children are usually seen at the CCRF in RMCH, and adults (18 years
and over) in the CRF in the MRI.
Would you like your study to run in:
CRF
CCRF
Both
Will the study require CRF staff to conduct visits outside the Facility?
Yes/No (if yes please give details)
Will all visits in the protocol require CRF support (staff or space)?
Yes/No (if no then please indicate which visits need support)
Will any visits be Day case visits (4-8 hours long)?
Yes/No (if yes please give details)
Will any visits be In-patient visits (8 hours or longer)?
Yes/No (if yes please give details)
Are other departments in CMFT involved in supporting the study?
Yes/No (if yes please give details)
Will you be paying travel expenses? (Details of how this will be organized will be discussed at the application
meeting.)
Yes/No
Does the study require any of the following?
Nursing
Medical Cover (see below)
Pharmacy
Human Performance
3T MR Imaging
Minor Procedures
lab
Room
Equipment (please state what equipment is required)
NIHR/WT Manchester CRF Application Form
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Laboratory Facilities
Ultrasound
Temperature controlled
room
Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
If the pharmacy will be
involved, please contact
Carolyn Davies, MRI
Clinical Trials Pharmacist
(CMFT)
0161 276 4623
clinical.trials@cmft.nhs.uk
If laboratory support is needed,
please contact Aisling Flatley,
Senior Biomedical Scientist at
the CRF, or Annelise Waite at
the CCRF
0161 906 7500
aisling.flatley@wtcrf.nhs.uk or
annelise.waite@cmft.nhs.uk
You will need to discuss any study
with imaging needs before
submitting an application: please
contact Frances Davies, MRIF
Project Manager
0161 275 0006
frances.davies@manchester.ac.uk
Please ensure that the necessary contact is made at the same time as applying to the
Manchester CRF, and before the study’s application meeting.
Medical Cover
The CRF may be able to provide, at a cost, a general medic and/or Advanced Nurse
Practitioner (AP) to support study activities such as physical examination and medical
history. They can also review ECG’s and adverse events if needed, as well as provide
immediate support for drug reactions. Any specialist medical support for the study will
need to be provided by the PI or his team. Please indicate below who will provide any
specialist medical support and be available if needed in the event of any serious adverse
events or reactions
MCRF AP/MedicError!
Reference source not
found.
Please note: The MCRF cannot provide 24 hour medical cover for studies or out of hours
support
NIHR/WT Manchester CRF Application Form
Page 5 of 6
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The user of this document is responsible for referring to Q-Pulse for the current version
Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
Clinical Research Facility
Central Manchester University Hospitals
NHS Foundation Trust
A1: MR Imaging Appendix
Please complete this section only if the 3T MR scanner at the MCRF is required.
If the study requires the use of other MR or PET equipment, please complete the Joint
Imaging Facilities Application form instead of this document. See
www.mhs.manchester.ac.uk/mrif/
Is a full scanning protocol available? *
If ‘no’, please detail specific protocol:
n/a: no MRI
If assistance is required in developing the scanning protocol, please contact Sue Stubbs
before submitting the application.
Scan cost for MR imaging
£
per hour
Number of participants being scanned: *
Number of scans per participant: *
Scheduled time per scan: *
hours
Total scanning time for study: *
hours
Estimated scanning time/month (based on recruitment
hours
target): *
Does the scanning component of the study have funding?
Yes
If yes: account code to be charged:
If no: is this an application for MRIF Grant for Scan Time?
Not Applicable
Will the study require MR scan contrast?
No
Total study costs for contrast agent(s):
£
Account code to be charged for contrast agents:
NIHR/WT Manchester CRF Application Form
Page 6 of 6
Free to Print
The user of this document is responsible for referring to Q-Pulse for the current version
Reference No: STU-FRM-1
Version: 7
Active Date: 06-Jun-2013
Next Review Date: Refer to Q-Pulse
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