Application and FAQ
Please complete the CAMRIS application. (You may save the application at any time and return to it).
Required documents:
- Study Protocol (brief study summary)
- IRB Protocol (HSERA form filed with IRB)
- MRI Imaging Protocol (PDF of the MRI sequences)
- Informed Consent Form (ICF)
- Site Qualification Survey (if applicable)
- IRB Approval (if available at time of submission)***
- Prospective Reimbursement Analysis (PRA) Spreadsheet
Once the application has been filled out and signed online, please press “Submit.”
If you are not able to completely answer all questions on the survey, please press “Save & Return Later” which will result in a “Return Code” necessary for reaccessing the application you started.
***IMPORTANT! Do you intend to use a device as part of your MRI protocol? If so,be sure to contact Norman Butler to discuss this aspect of your study, and then submit a request for a Device Assessment.
MRI Research at PPMC or PAH: CAMRIS does not review research studies that plan to scan at Penn Presbyterian Medical Center or Pennsylvania Hospital.
PPMC: If you need to perform your research MRI scans at PPMC, please fill out the PPMC Application form and work directly with the PPMC team who can better assess your needs.
Application Submission Deadlines
Please refer to the CAMRIS Important Dates page for information regarding when the monthly review meetings will be held and the deadline for submissions for each meeting.
If your protocol does not use PennChart/Radiant, then please complete the Research MRI Screening for Non-contrast Studies form for all subjects being scanned.
If you are interested in applying for a new ProDev award, please fill out the main CAMRIS Application. The application will request information on your current project and the plans to obtain future funding.
Awards are generally for 10 (one hour long) scan sessions.
To gain approval for a Continuation of an existing award, the study Principal Investigator (PI) will need to provide a justification as to why the additional time is needed.
CAMRIS will review all ProDev requests during the monthly review meetings and respond within 5 business days of the meeting.
-
Go to the LAIF webpage for general information
-
Complete the Application form & requirements (signed by the PI)
-
IACUC approval letter
-
IACUC Form “A”—the protocol document submitted to IACUC
-
MRI protocol (listing the sequences/parameters)
Once we receive, review and approve the protocol through CAMRIS, then access to the scheduling calendar is granted.
If the MRI portion of the protocol has been modified and/or amended, you must resubmit to CAMRIS. Go to the following link to access the Redcap Online CAMRIS Modification Form.
- If requesting a change of facility to Stellar Chance: Please complete the Stellar Chance Safety Stipulation Agreement form.
- List all requested MRI protocol modifications (for experimental sequences, send an email-approval from CAMRIS physicist Larry Dougherty or Hee Kwon Song), for amendment re: a device, send in manufacturer information & refer to CAMRIS Device Policy.
- Informed Consent Form (ICF)
- Imaging Manual/Imaging protocol .pdf download from the scanner
- Note: If your modification includes the addition of a device to be part of the scan process, this device will need testing, clearance, and approval from CAMRIS prior to use.
- You will need to fill out the required CAMRIS Device Assessment Form.
- If you have questions while developing a device or plans to purchase one, please contact Norman Butler, CAMRIS MRI Tech Manager.
Note: if you have added experimental sequences or coils with this modification request and do not currently have the experimental device clause in your consent form, you will need to send in a modification to the IRB for approval.
No, you do not need to renew your CAMRIS MRI protocol with the committee every year. However, it is the responsibility of the PI and/or his delegates (BA, Lab Managers) to ensure the CAMRIS Billing System has up-to-date funding and all appropriate staff listed under the protocol to ensure billing compliance. Failure to ensure this information is up-to-date will prohibit your approval to scan. Please see our Billing System page for more info on this topic.
Once you have sent in your new submission, you will await the next scheduled CAMRIS meeting (Note: be sure to check the CAMRIS Important Dates page to see the submission deadlines for each monthly meeting) for the review. Once the Review Meeting has been scheduled, CAMRIS requires 5 business days to process the review notes from various reviewers and send either the stipulation letter or approval letter. During this wait period it is a great time to ensure you have applied for your RBN (remember to check off ‘MRI Service Center’ on your Research Billing Application) and the CAMRIS PBR Billing System is set up with the funding source as well as ensure all study staff are listed under the protocol in the system.
Calendar Access Issues
If you received a CAMRIS approval letter and you are having difficulty scheduling on the CAMRIS PBR Scheduling calendar, please check the following:
- Did your PI/BA/Lab Manager add you into the PBR system as study personnel under the protocol # which would provide you with the access you need?
- If no, PIs/BAs/Lab Managers should follow these instructions for getting added to PBR.
- Did your Business Administrator enter the 26-digit BEN# into the system and link it to your protocol # to show active funding is available?
- If no, BAs can follow these instructions for adding a BEN#.
If YES to both questions above, then please contact CAMRIS Administrator, Margaret Ryan.
CAMRIS meets once every month for a review meeting (generally the first week of every month).
CAMRIS requires submissions to be received approximately 2-3 weeks from the Monthly Review Meeting. Please check the CAMRIS Important Dates page for information on meeting dates and submission deadlines.
No, CAMRIS no longer requires Continuing Review. However, it is required for each PI to ensure their funding information and study staff assigning is up-to-date in the CAMRIS billing system in order to continue scanning.
If your modification includes the addition of a device or a new experimental MRI sequence to be part of the scan process, this device/sequence will need testing, clearance and approval from CAMRIS prior to use.
Device(s)
If you have questions while developing or plans to purchase a device, please contact Norman Butler, CAMRIS MRI Tech Manager at Norman.butler@uphs.upenn.edu. Once this initial conversation has taken place, please go to this link to submit a request for Device Assessment.
Sequence(s)
All research pulse sequences (non-product sequences or product that has been modified) must be approved by CAMRIS prior to human use. Note that Siemens WIP (Works-in-Progress) sequences do not need CAMRIS approval. Please provide documentation via REDCap online submission which includes the following:
- A description of the sequence, including any changes to an existing sequence;
- How SAR and dB/dt are calculated ;
- A timing diagram, showing each component of the sequence with sufficient detail;
- Sample phantom images; and
- The range of relevant scan parameters that can be used.
Scan parameters that are changed at the console and that fall within the range submitted do not need further approval. Also, please submit the source code (just the relevant parts to sequence operation) to CAMRIS. Executable files need not be submitted. Submissions are confidential and will not be redistributed.
Subsequent changes to the sequence that are superficial in nature and do not change the fundamental imaging sequence do not need the full documentation described above. However, please submit a short description in REDCap that informs us of the change and the new sequence name. For example, modifying the UI that makes it easier for a user to adjust scan parameters does not need full documentation. However, please submit this description in REDCap that informs us of these changes.