MIMP Research Approval Form Vers 8

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MIMP Research Approval Form Vers 8 Powered By Docstoc
					                                                                                         Diirecttorate off Mediicall Imagiing & Mediicall Physiics
                                                                                         D rec orate o Med ca Imag ng & Med ca Phys cs


          Medical Imaging & Medical Physics ( MIMP ) Imaging Research Approval Form
In order to comply with Research Governance regulations and the Ionising Radiation Medical Exposure Regulations (IRMER) it is important
that you fully complete the form below and give detailed explanations of the examinations required including the imaging reporting
requirements.
The MIMP Directorate includes Radiology, Nuclear Medicine, MRI and Ultrasound.

The fully completed MIMP Approval form plus an electronic copy of the Protocol, Patient Information Sheet, Consent Form, study
imaging manuals and the completed IRAS NHS REC application Form Parts A&B should be emailed to sally.fleming@sth.nhs.uk and
to bridget.billingham@sth.nhs.uk Please copy all research related correspondence to both Sally and Bridget.

                                  Questions                                                           Response
   Full title of study and protocol version number.



   STH Research Department Registration Number.

   Name and Title and of Principal Investigator.


   Name of Study Coordinator and contact details.


   Please supply the name of the Lead Site and the name of the
   Authorising Ethics Committee.
   Short title to be used for Radiology Information System - RIS code (No
   more than 3 words).
   Study commencement date and duration (including any follow up
   period).


Authors, SF/BB
Latest update 8th March 2011
Version 8
                                                                                           Diirecttorate off Mediicall Imagiing & Mediicall Physiics
                                                                                           D rec orate o Med ca Imag ng & Med ca Phys cs


   How is the study funded?                                                 Commercial
                                                                            Grant funded
                                                                            Charitable funded
                                                                            NCRN/SYCLRN
                                                                            Other, e.g. Directorate, own account, please state
   Number of patients to be recruited to the study.

   Site where examinations to be performed e.g. WPH, RHH or NGH.


RESEARCH PROTOCOL IMAGING REQUIREMENTS
  Include modality, area of body to be imaged and if contrast is required. Also specify any reporting and image transfer methods required;
  there may be additional charges for this service.

Examination/ Scan/    Maximum number       How many of        Frequency of            Specific reporting                Do you require images
Therapy Type e.g.     of examinations      these are          procedures to be        requirements; state if not        copying to disc
CT Head with          per patient          standard of        performed e.g.          standard hospital report
contrast                                   care?              Baseline, 6, 12, 18
                                                              months




Authors, SF/BB
Latest update 8th March 2011
Version 8
                                                                                               Diirecttorate off Mediicall Imagiing & Mediicall Physiics
                                                                                               D rec orate o Med ca Imag ng & Med ca Phys cs


The following section is to be completed only if using Nuclear Medicine imaging / therapy as part of your study.


ARSAC
If you have indicated that Nuclear Medicine Imaging / Therapy will be required for your research study a research Administration Radioactive
Substance Advisory Committee Certificate – ARSAC will be required.
The application for an ARSAC Certificate requires you to answer the following questions –
.

Has a suitably trained and experienced individual been identified to     Yes / No
hold the ARSAC Certificate for all radiation exposures included in the   Please give details
study?
If the study already has an ARSAC Certificate for another UK site then   RPC ……/…..…/…….
please supply the ARSAC reference number
Does the study involve the use of a radiopharmaceutical which is not     Yes / No
currently in routine use within STH?                                     Please give details
Does the study involve the alternative use of an existing                Yes / No
radiopharmaceutical?                                                     Please give details

If an IRAS form has not been completed / included we will require a one page summary of the study which should include a reference to any
test involving the administration of Radioactive Substances and the reasons why they are being used e.g. to assess disease progression or
cardio-toxicity.

If you require further information please contact –
Sister Sally Fleming
Sister Bridget Billingham
Office number - 0114 2711813 or Bleep 872.




Authors, SF/BB
Latest update 8th March 2011
Version 8

				
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