V8 27.01.14
Research Approval Pro-forma for Radiotherapy and Radiology
This form should be completed by the research team and agreed with relevant staff in radiology and radiotherapy and in conjunction with the study Protocol, REC application
form and localised Patient Information Sheets. For further guidance on when and how to complete this form please refer to our pro-forma guidance or contact the Research &
Innovation department on 0117 342 0223.
Section A- Study information
R&I Number:
Study Title:
Principal Investigator (PI) at UH Bristol:
Tel:
Funding arrangements:Choose an item.
Estimated study start date (at this site):
/
/
Estimated number of participants:
Section B – Radiation Procedures
(i) Ionising Radiology
Ionising procedures (full
description)
Visits
Where more visits are required (i.e. the patient is routinely scanned
until disease progression, please make a note in the comments box)
Estimated
maximum dose per
procedure (Medical
Physics Expert to
complete)
Comments (including whether ARSAC
approval required)
*Please record all ionising radiology procedures to be carried out for the protocol, by marking it as RC if part of routine clinical care or X if required in addition to routine clinical
care.
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(ii) Non-ionising radiology
Non- Ionising
procedures (full
description)
Visits
Comments
Where more visits are required (i.e. the patient is routinely scanned
until disease progression, please make a note in the comments box)
*Please record all non-ionising radiology procedures to be carried out for the protocol, by marking it as RC if part of routine clinical care or X if required in addition to routine
clinical care.
(iii)
Radiotherapy/Radioisotopes
Radiotherapy/Radioisotopes Procedure
Description of standard care
Additional requirements for
research study
Comments
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Section C- Authorisations
These authorisations are encouraged to be obtained via email. This pro-forma should be sent to the necessary signatories in pdf format who
should return the pdf pro-forma with an accompanying email confirming authorisation. There is no need to document this agreement on the form.
If it is easier to obtain hard copy signatures please complete these below:
All ionising procedures require sign off by a Medical Physics Expert and an IRMER practitioner
IRMER practitioner authorisation:
Date:
Medical Physics Expert authorisation (diagnostic):
Date:
Medical Physics Expert authorisation (therapeutic):
Date:
Overall capacity/resource authorisation for radiology is required for all radiology procedures related to this study and should be completed by a site specific
radiologist).
Resource Authorisation:
Date:
Overall capacity/resource authorisation for radiotherapy/radioisotopes is required for all radiotherapy procedures related to this study.
Radiotherapy Resource Authorisation:
Date:
ARSAC:
If your study requires ARSAC please complete the relevant form on IRAS with assistance from the relevant Radiologist.
For guidance on who the appropriate signatories are please refer to our guidance document or contact Research and Innovation on 0117 342 0223
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