Download Advice should be obtained from the Radiation Protection Advisor If

9d. UHL IMAGING CBU
RESEARCH PROPOSAL FORM – Instructions for completion
This form must be completed by the investigator of a new research study that requires patients to undergo
tests performed by the Imaging CBU / Nuclear Medicine department.
Please include a copy of the study protocol with this form.
STUDY TITLE:
Full title
Short title:
Please place a short, consistent, title here that we can use to identity the trial on
request forms
Investigator:
Lead Investigator name
Is the trial funded and
by who?
What is the funding for
the radiological tests?
If no funding, why not?
State funding for tests
UHL Site:
Site at which Imaging
will be conducted
State reasons: e.g. imaging would have been performed anyway, standard
management, Imaging CBU agreed to cover costs etc.
Proposed start date:
Proposed end date:
Number of patients:
This is the number of anticipated patients at UHL only
Investigations
required:
Imaging Protocol
Frequency / Timing
~ no: Ix per patient
Specific protocol for imaging, if it is not stated we may do the wrong thing. For example:
Chest x ray
Standard PA
PA and Lateral
Baseline, visit 6, end of
study
3
Ultrasound
Abdomen / Pelvis / Liver
Screening
1
CT or MRI eg Chest /
Abdomen / Pelvis / Head /
Neck etc
None Specified / Standard
Reported to RECIST/
WHO etc
Baseline, Screening, end
of cycle 3, 6 etc
6
PET CT
Eg Base of Brain to groin /
Local protocol
Screening, 6 months, 1
year
3
Nuclear Medicine:
Bone Scan / Isotope scan /
Dexa / Muga
None Specified / Standard
Screening, 1 year
2
Are there any additional archive requirements?
If yes, please give details.
If images are required for external review please state
number of CDs and frequency of submitting data etc.
Revised Jan 2011
Are these investigations part of normal medical management?
*Advice should be obtained from the Radiation Protection Advisor
Investigation
EITHER
Indication
If so please give indication
If not please give estimated dose
OR
Dose reference limit*
1:
List clinical indication
2: e.g. Brain CT
Possible brain metatases
3: CXR
Normal volunteer
4: eg CT visits 3 & 6
Above standard care, required for study
protocol.
Seek advice from Radiation Protection
Advisor
PRINT NAME:
SIGNATURE:
Must be lead investigator. This is a legal form to
justify imaging tests
Must be signed by lead investigator
CONTACT NO:
DATE:
Please sign and send original to:
Professor B. Morgan
Radiology Dept
Leicester Royal Infirmary
Please sign and send original copy to Professor B Morgan. (Copy email may be sent if
required).
IMAGING APPROVED BY
DATE:
COMMENTS
Once approved by Imaging CBU you will be required to send this form with your R&D
application
Revised Jan 2011