Clinical Imaging Facility MRI Project Application

Instructions

  1. Please complete the Project Application form--Sections 1-7
  1. All human studies will require Ethics
  1. All ABMU studies will go through ABMU R&D Department.
  1. All healthy volunteers will go through Clinical Imaging Facility
  1. Forward completed application form with relevant documentation to

Paola Griffiths

Clinical Imaging Facility

Ground Floor

ILS2

College of Medicine

Swansea University

SA2 8PP

Useful contacts in the MRI Unit

Contact / Position / Email / Telephone
Prof
Rhodri Evans / Chair of Imaging / / 01792
606479
Paola Griffiths / Operational
Lead / / 01792
606739
Dr
Jonathan
Phillips / MRI Physicist / / 01792
606739

Section 1 – Applicant Details

1.1 Project Title

1.2 Principal Investigator Details

Name
Address
Department
E-mail
Telephone
MainEmployer
Honorary Contract
Please use CV template
template_cv.doc / attached

1.3.1 Co-Applicants Details (if any)

Name
Address
Department
E-mail
Telephone
Main Employer
Role in Study

1.3.2 Co-Applicants Details continue (add more as necessary)

Name
Address
Department
E-mail
Telephone
Main Employer
Role in Study

1.3.3 Co-Applicants Details continue (add more as necessary)

Name
Address
Department
E-mail
Telephone
Main Employer
Role in Study

1.4 Collaborators on the Project (all individuals involved with design and conduct of the research)

Name / Contact Details / Role in Study

2.1 Project Objectives - Protocol Synopsis

Title
Primary Objectives
Design and Duration
Sample Group
Evaluation Criteria
Data Collection
Data
Analysis
Time lines

2.2 Peer Review(required for all projects unless grant funded and already peered reviewed)

Group Name / Date

Section 3 – Participant Details

3.1 Total Numbers of Participants

3.2 Number of Healthy Volunteers(if relevant)

3.3 Patients(ABMU approval and honorary contract needed)(if relevant)

Trust / Department / Contact Name Person
Email and telephone

3.5 How will participants be recruited to your study?

3.6 Please state the inclusion and exclusion criteria? other than MRI safety

Inclusion
Exclusion

3.7 Ethical Approval of ALL Human Studies is requiredfrom 1 of the following committees.

Committee / Ethical Approval / Copy Attached
ResearchEthics Committee
REC
Health and Human Sciences Ethics Committee
School or College Specific Ethics Committee

3.8 MHRA approval (if relevant)

Document / Date / Attached

Section 4 – MRI Operational Details

4.1What is theMRI projected protocol? (Attached a copy)

4.2 What is required (any additional equipment, procedure or staff involvement)

fMRI
Contrast
And
Blood test
Scan Operator
Incidental findings
(reporting)
Data Analysis
MRI Physicist

4.3Number of MRI hours

Scans per participant / Total scan hours

4.4 Booking requirements(please indicate, booking is 9-5 Mon to Fri only)

Block-booking
Dates
Times

4.5Health and Safety(any risks issues related to this study or the participants being recruited?)

4.6 Medical Cover (all studies involving an invasive procedure or drug administration must name a medically qualified person who take responsibility and is available for IMMEDIATE MEDICAL ASSITANCE)

Name / Contact details / Relevant H&S training undertaken

Section 5 – Funding Information

5.1 Contact person for Invoice Details

Name
Address
Email
Telephone

5.2Invoiced details for Costs of the MRI Project(to be completed by CIF staff)

Funding / Amount / Account Code / Invoice Total
Internal
University Department
External
(to Swansea University)

5.3 Insurance(Swansea University will have indemnity cover for its responsibilities and activities, and likewise the external party should arrange their own cover)

Insurance for External Parties / Attached
Company
Name
Address
Email
Telephone

5.4 Sponsorship (The Sponsor is an institution or organisation that takes on the legalresponsibility for the initiation, management and conduct of the research study)

Internal Swansea University / Institutional Endorsement Form
(from DRI ) / Attached / Yes/No/NA
External Company
E.g. MRC or
Welcome Trust / Relevant form or Sponsorship letter / Attached / Yes/No/NA
ABMU R&D Department / Research Governance Form
R&D Form / Attached / Yes/No/NA

Section 6 – User Agreement

Agreement and Declaration

We agree the following terms:-

a)Following approval, the study will be conducted in accordance with the protocol and all other details in this application.

b)The study will only commence when relevant ethical approval from the Ethics Committee has been obtained.

c)That appropriate funding has been arranged and is in place for this study.

d)All documents have been received and checked.

e)A copy will be kept by both parties.

f)Publications from work carried out at the MRI facility should carry due acknowledgement.

g)All operators must undertake the MRI Training program and read the Standard Operating Procedure relevant to the MRI Unit.

h)Any cancellations of booked MRI Slots with less than 5 full working days (Mon-Fri) notice, will be charged at full costs. If 5 or more days notice is given, no charge will be levied.

All signatures must be original signatures

Signature of Principal Investigator

CIF MRI Project Application Form Jan 14 Private and ConfidentialPage 1 of 10

Principal Investigator: / Date:

CIF MRI Project Application Form Jan 14 Private and ConfidentialPage 1 of 10

Signature of JCRF/CIF Director.

JCRF/CIF DIRECTOR / Date:

Section 7 – Documents

7.1 List of attached

Documents / Attached
CV
Ethics
Protocol
Sponsorship
Research Governance Form (DRI)
Insurance
MHRA

Section 8 – MRI Office Use Only

8.1 Project Code

MRI Code / Start Date
Completed Date
Checked / Signed
Risk Assessment
Sponsor Letter
MRI Costs
Staff Allocation
Incidental Finding
Authorisation

End of document

CIF MRI Project Application Form Jan 14 Private and ConfidentialPage 1 of 10