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How to conduct a study on the 7T

The following describe step-by-step the process needed to get a project approved and executed:

Project description

You must first submit a short resume of the study to the executive committee (click here for the template). The project description should be emailed to . It will then be processed at the first upcoming meeting, which takes place approximately every 3 months. It is important to state in the project description what the aim of the study is, the type of subjects, how many and for how long in the scanner. It must also be justified why the ultra-high field 7T is necessary for the project, rather than using a clinical field strength of 3T. To avoid disappointments, it is crucial to submit the project description as early as possible, i.e. before applying for funding, etc. In addition, it is recommended that you consult the 7 tesla group (Esben Thade Petersen: ) to discuss the feasibility of the study and whether the study would require additional equipment and/or human resources that will need to be included in future grant applications.

Formalities

Initial approval from the executive committee is under the condition that the following formalities are subsequently in place before project initiation: 

  1. Ethical Committee Approval (Videnskabsetisk komité)
  2. Danish Medicines Agency (Lægemiddelstyrelsen)
  3. Good Clinical Practice (GCP)
  4. Danish Data Protection Agency (Datatilsynet)
  5. Registration of the project with Philips Healthcare
  6. 7T Project Safety
  7. 7T Training and Access

Project initiation

After finalization of step 1 and 2: 

  1. Documentation in the form of softcopies of all documents and approvals in step 2 must be sent to
  2. Danish Medicines Agency 
    1. Must be notified when the first subject is recruited.
  3. Good Clinical Practice initiation
    1. GCP to be informed about the study initiation.
    2. Trial Master File must be located at DRCMR and remain updated (Overview of Trial Master File content).
    3. GCP will perform an initiation visit on site before the first subject.

Project execution: 

  1. MRI Scanning and Safety Procedures
    1. To be followed according to the 7T training.
  2. Good Clinical Practice monitoring
    1. Audit approximately every 6 months at the scanner.
  3. Philips Healthcare
    1. All research projects need to fill out a form (annex to research contract), and provide a copy of the letter stating that the study is approved by the ethical committee 
    2. Philips Extended Collaborations:
      1. Regular status reports.
      2. Manuscripts to be handed to Philips 30 days in advance of submission.
  4. Ethical Committee 
    1. Yearly reporting to the ethical committee
  5. Unexpected findings
    1. Responsibility of the medical adviser of each study
  6. Serious Adverse Events (SAEs)
    1. Immediate reporting to Hvidovre Hospital
    2. Subsequently to the Danish Medicines Agency, the ethical committee and Philips
    3. SAEs must be logged in the GCP Trial Master File

  

A. Ethical Committee Approval (Videnskabsetisk Komité):

  1. Within Region H: https://www.regionh.dk/til-fagfolk/Forskning-og-innovation/Kliniske-test-og-forsoeg/Sider/De-Videnskabsetiske-Komit%C3%A9er.aspx
  2. We can provide templates
    1. Informed consent form
    2. Screening form (fixed template) 
    3. Post scanning questionnaire (fixed template)
  3. Copies of the protocol and approval must reside in the Trial Master Folder (GCP) at Hvidovre Hospital.
  4. The protocol must match the one sent to the Danish Medicines Agency. 

B. Danish Medicines Agency (Lægemiddelstyrelsen):

  1. Required documentation:
    1. Cover letter
    2. Project protocol
    3. Investigators brochure 7T (fixed document, although additional documents may be required depending on the project)
    4. Description of the equipment's labeling (two fixed documents)
    5. Philips 7T user manual (fixed document)
    6. Safety aspects (partly fixed document)
    7. Statement from Philips regarding the risks associated with the current study 
    8. Written participant information
    9. Informed consent form
    10. GCP monitoring plan and contract (the project protocol must state that GCP is involved and responsible for full monitoring). 
  2. Please contact Vanessa Wiggermann () or Henrik Lundell () for advice and the latest document requirements and templates. 
  3. We advise to use our latest template to ease the processing!
  4. Everything can be written in English!
  5. Be aware of the approximately 22000 DKK processing fee!
  6. Decision within 60 days and typically little response time for additional information! 

C. Good Clinical Practice (GCP):

  1. GCP of RegionH monitors all projects, also from Aalborg, Aarhus and Odense
  2. Involve them early
  3. 100 Hours for free for each project registered at Danish Medicines Agency
  4. Will check documentation in Trial Master File and that source data is stored and organized
  5. GCP initialization before the first subject is scanned (inform them well in advance)
  6. Audit approximately every 6 months at the scanner
  7. All documents must be in the Trial Master Folder (CV’s of all involved personnel, protocols, forms, etc.).
  8. Please contact Vanessa Wiggermann () or Henrik Lundell () for advice and the latest document requirements and templates. 

D. Danish Data Protection Agency:

  1. As original source, data must reside at Hvidovre Hospital, agreements must be made with all partners outside RegionH. 

E. Registration of the project with Philips Healthcare: 

  1. Contact our Clinical Scientist from Philips (Paul de Bruin, ). 

F. 7T Project Safety:

  1. Projects using the default setup:
    1. No additional safety assesments required.
  2. Introduction of new equipment:
  3. For safety validation, a specific quality assurance protocol will be put in place. This will follow the IEC guidelines (IEC60601).  
  4. This protocol includes: (1) testing of basic electronic parts; (2) electromagnetic field simulations (SAR), matched with electromagnetic field measurements; and (3) high-duty cycle heating measurements in tissue-matched phantoms. This is required to ensure MR conditional use of all newly developed coils. 
  5. To be verified and approved in collaboration with the 7T physics group.  
  6. Contact Vanessa Wiggermann () or Henrik Lundell () for further information 

G. 7T Training and Access:

  1. To gain access to the 7T the following is required. 
    1. An approved project must exist where the operator (the responsible for scanning) or assistant (helping with subject handling) are participants
    2. The operators and assistants must go through a general introduction to Hvidovre Hospital and DRCMR
    3. The operators and assistants must take the MR safety courses
    4. The operators must take the full 7T driver license
    5. The assistants must take the parts of the 7T driver license
    6. When all requirements are fulfilled, there will be given access to the booking system and access cards will be made
  2. Contact Vanessa Wiggermann () or Henrik Lundell () for further information on how to initiate these steps