CAMRIS

CAMRIS Application and FAQ


If applying for a ProDev, please visit this webpage: https://www.med.upenn.edu/cbi/operational-support.html 

How Do I Apply?

Please go to this link and complete the application. (You may save the application at any time and return to it).

The link to the application: https://redcap.med.upenn.edu/surveys/?s=WJD8JW9NEN

Required documents:

  1. Study Protocol
  2. IRB Protocol (Protocol Details Page)
  3. MRI Imaging Protocol
  4. Informed Consent Form (ICF)
  5. Site Qualification Survey (if applicable)
  6. Prodev Approval (if applicable)
  7. IRB Approval (if available at time of submission)***

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 ( norman.butler@uphs.upenn.edu ) to discuss this aspect of your study, and then submit a request for a Device Assessment   https://redcap.med.upenn.edu/surveys/?s=LT9WPJ84CC

Application Submission Deadlines

Please refer to the CAMRIS Important Dates tab for information regarding when the monthly review meetings will be held and the deadline for submissions for each meeting.
http://www.med.upenn.edu/camris/importantdates.html

If your protocol does not use PennChart/Radiant, then please complete the following form for all subjects being scanned: Research MRI Screening for Non-contrast Studies

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How do I apply for an Animal Study?

CAMRIS would need the following information sent to this email box: camriscommittee@uphs.upenn.edu
 
1.       Go to the LAIF webpage for general information https://www.med.upenn.edu/camris/about-laif.html 
2.       Application form & requirements (signed by the PI) https://www.med.upenn.edu/camris/laif-apply.html
3.       IACUC approval letter
4.       IACUC Form “A”—the protocol document submitted to IACUC
5.       MRI protocol (listing the sequences/parameters)
6.       Animal Safety Statement form (signed by PI)
 
Once we receive, review and approve the protocol through CAMRIS, then access to the scheduling calendar is granted.

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What if I want to use the Stellar Chance MRI facility?

Please complete the following form and upload it with your New Application Submission for review or with your Modification Submission: Stellar Chance Stipulation Form: Stellar Chance Stipulation Form

This applies to the following two situations

  1. New applications requesting Stellar Chance
  2. Modification to an existing protocol requesting a change to the Stellar Chance facility

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MRI Protocol Modifications/MRI Protocol Amendments – Submission Required

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:  https://redcap.med.upenn.edu/surveys/?s=X3ECRLT9A3

  1. If requesting a change of facility to Stellar Chance: Please complete this form
  2. 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
  3. Informed Consent Form (ICF)
  4. Imaging Manual/Imaging protocol .pdf download from the scanner
    1. 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.
    2. You will need to fill out the required CAMRIS Device Assessment Form which is accessible via this link:  https://redcap.med.upenn.edu/surveys/?s=LT9WPJ84CC
    3. If you have questions while developing a device or plans to purchase one, please contact Norman Butler, CAMRIS MRI Tech Manager at norman.butler@uphs.upenn.edu.

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.

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Where Do I Find The Application?

Human MRI Scanning: Access the Redcap Application for Human MRI Research scanning here: https://redcap.med.upenn.edu/surveys/?s=WJD8JW9NEN

Large Animal Imaging (LAIF) Application can be accessed here: https://redcap.med.upenn.edu/surveys/?s=MFWLFJK9WJ

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Do Human Subject protocols need to be reviewed every year?

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 separate section “CAMRIS PBR Billing System” for more info on this topic.

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I’ve applied, now what?

Once you have sent in your new submission, you will await the next scheduled CAMRIS meeting (approximately 2 weeks from the submission deadline) 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.

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I’m approved but am unable to schedule, what do I do?

CALENDAR ACCESS ISSUES
If you received a CAMRIS approval letter and you are having difficulty scheduling on the CAMRIS PBR Scheduling calendar, please call one of the following CAMRIS Administrators:

Protocols that utilize Stellar Chance magnets & resources--Margaret Ryan at 215-573-8486 or email at ryanm@pennmedicine.upenn.edu

Protocols that utilize HUP-based scanners (Founders, Devon or PCAM scanners)--Shannon Long at 215-573-9765 or email at shannon.long@uphs.upenn.edu

Please ensure you are listed on the protocol in the CAMRIS PBR billing system first as this is a requirement in order to block time on any protocol on the calendar system. Your PI or BA can add you onto the protocol if you find you are not listed.

 

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How often does CAMRIS meet for review?

CAMRIS meets once every month for a review meeting (generally the first week of every month).

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When is the deadline for submissions?

CAMRIS requires submissions to be received approximately 2-3 weeks from the Monthly Review Meeting. Please check the CAMRIS Important Dates tab for information on meeting dates and submission deadlines.

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Does CAMRIS require Continuing Review?

No, CAMRIS no longer requires Continuing Review. However, it is required for each PI to ensure his/her funding information and study staff assigning is up-to-date in the CAMRIS billing system in order to continue scanning.

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If I have a device or new, experimental MRI sequence I want to use, how do I go about getting approved by CAMRIS?

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.  https://redcap.med.upenn.edu/surveys/?s=LT9WPJ84CC

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:

(1) a description of the sequence, including any changes to an existing sequence; 
(2) how SAR and dB/dt are calculated ;
(3) a timing diagram, showing each component of the sequence with sufficient detail;
(4) sample phantom images; and
(5)  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.

REDCap link: https://redcap.med.upenn.edu/surveys/?s=EK3NTJE7FX

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