August 2nd, 2018
CAMRIS is informing all researchers to the recent FDA Update regarding use of Gadolinium-Based Contrast agents (GBCAs) in MRIs. The FDA has specifically updated the Prescribing Information due to concerns with gadolinium (a heavy metal) remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.
However, the FDA has stated that after additional review and consultation with the Medical Imaging Drugs Advisory Committee, they are requiring several actions to alert health care professionals and subjects about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide*--providing educational information that every subject will be asked to read before receiving a GBCA, in addition to requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.
All research MRI studies that are currently using--or plan to use--a GBCA contrast agent please read the FDA Update found here:
Changes to the CAMRIS Policy Regarding Use of GBCAs in MRI Research
CAMRIS has determined that a reference to these deposition issues must be included in all ICFs for studies that require use of a GBCA. The FDA Update mentions Medication Guides should be provided to subjects. These guides are now available for all subjects requiring a GBCA for their MRI study & should be provided to each research subject during the consenting process (Note: downloadable documents can be found on the CAMRIS website under "MRI Contrast Info" tab).
In addition to the revised CAMRIS GBCA Risk Language, it will be up to each Investigator to ensure his/her study teams adequately explain the GBCA risks to each subject during the Informed Consent process.
The new, updated GBCA Risk Language for the ICF which should read as follows:
Retention: Traces of gadolinium may remain in the body long-term after contrast administration. This risk increases with the number of administrations, but reviews to date have not identified adverse health effects from gadolinium retained in the brain or bodily tissues after MRI ([Gadolinium agents administered in this study are thought to minimize or eliminate this risk *]).
If you would like more information, please go to this link https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm or ask the study team for more information.
*excluded for studies using linear GBCA.
When shall I update my study documents?
For current, ongoing CAMRIS studies—
Studies that are currently enrolling must modify their ICF with the new CAMRIS GBCA Risk Language within 90 days of the GBCA update notification. Those subjects who will be returning for additional MRI time points must be re-consented with the IRB-approved, updated ICF.
For studies not currently enrolling—
Non-enrolling studies can submit this change with another planned modification to update their ICF with the new CAMRIS GBCA Risk Language.
Principal Investigators & Study Medical Staff
Updated--CAMRIS GBCA Administration Policy
Macrocyclic agents will be used in all CAMRIS research studies requiring Gadolinium contrast based upon evidence of significantly lower Gadolinium retention from macrocyclic agents versus linear agents.
The following limited exceptions will be considered, but require review and approval by the CAMRIS scientific/safety review process prior to study approval:
Protocols where the research MRI studies are performed in conjunction with clinical MR imaging procedures that use non-macrocyclic agents.
Multi-center protocols specifying a non-macrocyclic agent.
Strong consideration will be given to recommending against non-macrocyclic agents in the above circumstances in the absence of patient benefit- for example, clinical interpretation of the research study or requirement for access to a potentially beneficial treatment.
Dose and GFR
Any subject without known renal disease will not need to undergo a creatinine level. CAMRIS will accept attestation of medical history regarding absence of known renal disease.
Any subject with known renal disease of any severity undergoing administration of a contrast agent for research imaging in MRI must have a creatinine level available for the calculation of their GFR. The creatinine level must be within the last 6 months from the date of the research MRI. The most recent creatinine level must be used for the GFR calculation. ISTAT creatinine levels can be made available through arrangement with CAMRIS for a fee. Use of the ISTAT is not part of the scheduled time on MR scanner and will be in addition to the projects’ scheduled slot. Please plan accordingly. This service is charged on a per-session basis. ISTAT values can be used for subsequent scans out to the 6 month limit.
All contrast imaging will be performed using the Clinical Macrocyclic Agent, unless otherwise specified and arranged through CAMRIS by the Investigator.
Any change in dosing as described below must be arranged through CAMRIS.
All GBCA’s administration will follow the clinical standard.
Any GFR calculated below 45ml/g/m3 the Investigator must provide must a signed Gadolinium prescription from a UPENN Radiologist (situation #2,#3 below)* and the prescription must give dose and type of GBCA to be administered.
Subjects with a GFR ≥ 45ml/g/m3 may receive the standard 70% dose of the Clinical Macrocyclic Agent Subjects with a GFR ≥ 30ml/g/m3 AND < and45ml/g/m3 may receive the standard 50% dose of the Clinical Macrocyclic Agent* Subjects with a GFR < 30ml/g/m3 call and arrange directly through a Radiologist* Pregnant subjects** cannot be administered gadolinium for research. If your protocol seeks to include pregnant subjects and administer gadolinium please contact the IRB.
FDA-Approved GBCAs* currently available in HUP Radiology/CAMRIS
Dotarem† :gadoterate meglumine--(used in instances of lower GFR and/or CVI Imaging studies)--Macrocyclic
Gadavist†: Gadobutrol (used in replacement of Dotarem in specific CVI cases)--Macrocyclic
ProHance†: Gadoteridol (used for Neuro Imaging studies)--Macrocyclic
Eovist: gadoxetate disodium (used for Liver & Body imaging studies)--Linear
MultiHance: gadobenate dimeglumine (used for Musculoskeletal imaging studies)--Linear
*Linear GBCAs result in more gadolinium retention in the body than macrocyclic GBCAs.
†Gadolinium levels remaining in the body are LOWEST and similar after use of these agents.
CAMRIS website link to recent FDA Update regarding contrast use in MRI Research:
September 28th, 2017
To: MRI Approved Users—those CAMRIS-trained individuals who have clearance to run their own CAMRIS MRI scans.
CAMRIS has been made aware of PBR scan sessions that ‘time out’ before you can formally “Finish” an active scan session.
Simply closing the browser window DOES NOT fix the issue.
This can actually cause billing issues for your protocol.
During your active scan session, if you notice your PBR window says “Session Expired” please do the following:
1. DO NOT close the browser window
2. Click on “CHECK-IN” tab on the upper left side bar, just as you would to start a scan
3. Log-in with your study team member pennkey (any study member listed on the protocol in PBR)
4. On the right side of the page you can choose the correct “Open Session” to get back to your active scan
--this will resume the current scan session that timed out, then hit “Finish” to properly end the scan.
Please email or call me with any questions or if you need clarification.
Thank You Everyone!
Ms. Shannon Long
September 22, 2017
RE: MRI Service Center (CAMRIS) Rate Changes
Dear Research Community,
Effective, January 1, 2018, the MRI rate will be increased by $50. The increase is needed to support additional resources and increased costs by our vendors. You should expect an increase of 2-3% annually moving forward.
In addition to the increased rate, we are instituting a no show/late cancellation fee of $50. This fee will be charged if you do not cancel your slot > 24 hours of the scheduled appointment time and/or do not communicate with the MRI team on justification for not showing up at the scanner.
MRI Rates Effective January 1, 2018
Human MRI (government)
Human MRI (Industry sponsored)
Human MRI (investigator initiated)
Thank you for your understanding,
Director, Research Operations
Tuesday, September 5th, 2017
7T Prodev Funding Award
Deadline for submission 9/15 and 12/15
- 7T (non-contrast) MRI scans
- Collaborative work with Radiology and another department (Radiology faculty and/or staff must be listed on protocol)
- Clinical research (human subject)
- Max number of scan awards per award: 18 (can only apply for an extension one time).
- Progress report must be submitted to the committee within 6 months of award (lack of progress award will result in cancellation of award)
Apply through this link: https://redcap.med.upenn.edu/surveys/?s=FFK83F3TXX
Funding will be awarded to 5 PIs each of the cycles noted above. Awards will be granted based on scientific merit.
Awards will be announced the week of October 2, 2017.
Monday, April 3rd, 2017
IMPORTANT CAMRIS SCHEDULING UPDATE—TRAINING SESSIONS INFO
May 1st 2017
CAMRIS will fully switch to a new scheduling calendar “CAMRIS PBR Scheduler”
The current CFN will be locked on May 1st.
This PBR Scheduler is the final piece of the mandate from OCR in our effort to create a system that ties together system scheduling, billing, and protocol information.
Prior to May 1st
There are two things you must do:
1. Add all key users onto your account
2. Attend Information Session
PIs, Business Administrators, Lab Managers!
It is imperative that all those involved in the scheduling of CAMRIS MRI protocols can access the new calendar.
PIs, BAs and Lab Managers have the authorization to add any personnel by pennkey to their protocol (this is not to be done by CAMRIS for auditing reasons).
Access to scheduling on the new calendar is ONLY provided to those study team members currently listed in PBR.
Establishing and updating access is the responsibility of PI/User groups/BAs & Lab managers.
CAMRIS does not manage user access.
Study Team Members—Coordinators, Research Assistants, etc.
Assist your PI, BA and/or Lab Manager with this effort by using the link below to check your access.
If the study/IRB# does not show on the list, then you need be added to the system ASAP.
PBR Checker tool: https://weblogin.pennkey.upenn.edu/login?factors=UPENN.EDU&cosign-bioinformatics-pathbio-0&https://pathbio.med.upenn.edu/pbr/secure/camris/camris/camris.php
RVSP below with the session will attend:
Session 1: April 20th will be held in the Donner Auditorium, 1:30-2:30pm
Session 2: April 27th will be held in 252 BRB, 10-11am
We appreciate your efforts, enthusiasm and constructive feedback during this transition period. Thank you!
Adding Study Team Members to a CAMRIS Protocol
(Note: disable your pop-up blocker)
1. Click on: https://somapps.med.upenn.edu/pbr/portal/
2. Click on your appropriate access link (either PI, Lab Manager or Business Administrator).
a. BAs and Lab Managers--choose PI name from the list & select which study you need to amend
3. Now on Lab Management page, hover over light blue bar towards top that says ‘Additional Management Tools’
4. Click on CAMRIS Protocols located in yellow pull-down area
5. Click on the IRB protocol # you want to amend
6. In the pop-up screen go to “Add New Member” and place pennkey username in this area and hit submit. Done!
March 22nd, 2017
CAMRIS Submissions Deadline Change
CAMRIS will be moving their monthly review meeting from the 3rd week of every month to the first week of every month. Occasionally these dates may change due to holidays and/or resource conflicts so please be sure to check the website for any changes.
Therefore, CAMRIS will now require that all submissions of NEW protocols be received by the submission deadlines outlined below.
(Note: Modifications to previously-approved CAMRIS protocols will be reviewed on a rolling basis)
2017 CAMRIS Important Dates
April Review Meeting—4/5 (Wed)
Submission deadline for April meeting—3/23 (Thurs)
May Review Meeting—5/1 (Mon)
Submission deadline for May meeting—4/17 (Mon)
June Review Meeting—6/5 (Mon)
Submission deadline for June meeting—5/15 (Mon)
July Review Meeting—7/11 (Tues)
Submission deadline for July meeting—6/19 (Mon)
August Review Meeting—8/1 (Tues)
Submission deadline for August meeting—7/17 (Mon)
September Review Meeting—9/11 (Mon)
Submission deadline for September meeting—8/21 (Mon)
October Review Meeting—10/2 (Mon)
Submission deadline for October meeting—9/14 (Thurs)
November Review Meeting—11/6 (Mon)
Submission deadline for November meeting—10/16 (Mon)
December Review Meeting—12/4 (Mon)
Submission deadline for December meeting—11/16 (Thurs)
How do I submit to CAMRIS?
CAMRIS Pregnancy Policy—REMINDER!
CAMRIS is receiving a number of protocol submissions with outdated Pregnancy language in the ICF and protocol. Please ensure your study documents are updated to reflect the change set forth in September 2015.
MRI and Pregnancy Testing:
Consistent with clinical care standards, pregnancy testing is not required prior to conducting MRI scans for research purposes. Attestation of pregnancy is accepted at the time of MRI screening. Existing studies that currently include pregnancy testing prior to scanning should be amended to remove the requirement and be submitted to the IRB for approval.
CAMRIS no longer guarantees the availability of urine pregnancy testing kits.
For protocols that require mandatory pregnancy testing, the responsibility will rest with the PI to purchase the urine pregnancy testing kits and for the administration of those tests.
Sample consent language if your protocol lists pregnancy as exclusion criteria:
Pregnancy Risk: Although there are no known risks related to MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. Since there is no possible benefit from participating in this protocol for a pregnant woman, we will exclude pregnant women.
July 12th, 2016
CAMRIS: Important Info regarding Scheduling/CAMRIS PBR Billing System log-in
ATTENTION ALL CAMRIS Users:
BE AWARE there is an increasing number of Investigators/Coordinators that are coming to the scanners without being able to log-on to the PBR system. In the majority ( if not all ) cases this problem rests with the Investigative group not making sure they can log-on before they show up at the scanner. You should be using this PBR Checker tool https://pathbio.med.upenn.edu/pbr/secure/camris/camris/camris.php to make sure you are able to process billing.
Beginning in the LAST WEEK OF JULY if you are unable to find your IRB and/or cannot log into the system this will be YOUR PROBLEM and you will not be able to scan for the session.
Please work with your PI, BA or Lab Managers to be sure this is not the case.
Those groups that do schedule in EPIC/Radiant and take slots on the CFN calendar will be subject to the 72 hour rule. If we cannot corroborate the CFN time slot with a valid RADIANT scheduled subject, the slot is FORFEIT without question. This could be a painful situation for some so be sure to get the study scheduled.
Those Out-of-EPIC groups that want to scan in time slots on the HUP scanners will need to CONFIRM all of those slots by placing the word “CONFIRMED” into the study notes on the CFN calendar.
Those slots not showing the “CONFIRMED” status are subject to FORFEIT. Also, if there are groups that develop a habit of ‘no-shows’ for those Out-of-EPIC slots there will be a direct punitive action of deletion of slots following that no-show.
Please use your time as you are being given a break in not needing to place your studies into the RADIANT system. Thank You.
Norman Butler, CAMRIS Committee
June 8th, 2016
NEW PBR Scheduler/Calendar coming July 2016
Dear CAMRIS Community,
CAMRIS is excited to announce a new ‘Scheduler/Calendar “component to the existing CAMRIS PBR Billing System. This new calendar is slated to launch July 2016 for testing.
Full implementation is expected by October 2016 or sooner. Until notified the current CFN Calendar is still your scheduling resource.
BAs, PIs and Lab Managers
It is IMPERATIVE that all protocol accounts are updated in the CAMRIS PBR system before the transition can take place. This means that all funding sources need to be current, all studies must have IRB approval, and ALL personnel that will be escorting subjects to the scanner MUST be listed in the PBR system.
As always if funding and/or IRB are expired, or if you are currently study staff and not listed in the PBR system, you will not be able to block time. You risk the chance of not being able to scan as manual entry will not be possible.
Use the account checking tool (link is below) to check the status of the protocols you assist with. Get in touch with your BA/Lab Manager/PI and make any necessary changes now. Please keep them updated on any email blasts so when information is moved to the new scheduling system you are ready and can log into the PBR system without issues.
“PBR account checking tool” link:
CAMRIS will schedule Q&A/training sessions for this new PBR Scheduler in a few weeks.
Please be on the lookout for future CAMRIS email updates titled “CAMRIS PBR Scheduler” in the subject line.
Thank you for your attention and cooperation!
April 11th, 2016
NEW! CAMRIS Online Submission Portal (REDcap)
CAMRIS is excited to announce a NEW online application/submission process for researchers interested in utilizing the CAMRIS service Center.
The CAMRIS application has been recreated in REDCap and accessible via any web connection.
Link to application: https://redcap.med.upenn.edu/surveys/?s=WJD8JW9NEN
This new application requires additional information regarding the technical needs of your MRI protocol. Please be sure to consult with your Radiology contact on your study for any questions (e.g., coil type, sequences (experimental or standard?), length of MRI study based on your specific MRI protocol (60, 90 min, etc), brief description of the inclusion/exclusion criteria for subjects), do images need to be uploaded to a server (PACS)?).
CAMRIS requires all new submissions to utilize this new online application moving forward.
If you are experiencing any technical difficulties, please contact Shannon Long at CAMRIS 215-573-9765 or email at Shannon.firstname.lastname@example.org
CAMRIS Website Link: http://www.med.upenn.edu/camris/
November 17th, 2015
Dear CAMRIS Community,
A few things…
CAMRIS PBR Billing System Reminders
- You MUST log in with your OWN pennkey. You cannot use another person’s pennkey to log on. This is against HUP and university policy.
- Check whether you will have issues logging in prior to coming to the scanner with your subject by using this—‘PBR checker tool link’-- and entering your pennkey username https://pathbio.med.upenn.edu/pbr/secure/camris/camris/camris.php
**If your protocol# is NOT showing up, or lists the protocol is expired or the funding is frozen, contact your BA, or contact Shannon Long 215-573-9765 to troubleshoot.
PIs, BAs and Lab Managers
Note: This billing system is subject to financial audit, therefore It is the responsibility of the PI, BA or lab manager to add personnel onto a protocol in the PBR system which signifies PI authorization for those chosen study members to bill scans to the linked account. Please encourage your study team members to check for issues prior to coming to the scanner with the provided link for the ‘checker tool’ in #2.
Next PBR Q & A Session
When: Wednesday, Nov. 18th
Location: MRI Small conference room, 1 Founders, MRI Education Center
In Attendance: Shannon Long, CAMRIS Manager and Bill D’Arcy, Radiology Business Administrator
Anyone with questions, concerns or confused about how to navigate the PBR system please come see us.
This is an informal meeting, just walk-in for a one-to-one sit down.
Updated CAMRIS website link, please bookmark:
October 27th, 2015
Subject: ICD9 to ICD10: Changes to Research
Attention Research Community:
This email is a follow up to the email sent on September 30th with information regarding the replacement of ICD-9 diagnosis codes to ICD-10 codes. As specified in the previous email, the v70.7 code that is attached to visits/ test/ procedure performed on a research subject and billed to insurance will no longer be utilized and should be replaced with ICD 10 code Z00.6.
For studies which previously used v70.9 code (general unspecified) the new ICD-10 code is Z00.8. The options under Z00.8 are for non-specific diseases. Select the code that best matches your population of research patients/ participants. Regardless of what is chosen in this drop down, the ICD-10 code in EPIC will route to Z00.8
The PennChart team has drafted two tip sheets which are included with this email to assist with the following:
- Utilizing the Z00.8 and Z00.6 ICD-10codes - http://www.med.upenn.edu/ocrobjects/secure/announcements/ICD-10_TipSheet_PennChart.pdf
- Adding the RES Modifier for Service Center Procedures - http://www.med.upenn.edu/ocrobjects/secure/announcements/RES_TipSheet_PennChart.pdf
If you have any questions regarding ICD 10 codes or the tip sheets please contact either the Office of Clinical Research (OCR) at email@example.com
For more information on the ICD-10 transition:
Please visit: http://uphsxnet.uphs.upenn.edu/ICD-10Project
Send your questions to: ICD-10.Questions@uphs.upenn.edu
Office of Clinical Research (OCR)
October 5, 2015
Attn: All CAMRIS Investigators/Coordinators
Subject: ICD-10 codes announcement
As of October 1, 2015, ICD-9 diagnosis codes were replaced with ICD-10 codes.
The V70.7 code that is attached to visits/tests/procedures performed on research subjects and billed to insurance will no longer be utilized.
This code will be replaced with the ICD-10 code Z00.6, which will reflect "encounter for examination for normal comparison and control in clinical research program."
The new code for “general unspecified” is Z00.8 (This code is in place of V70.9).
For more information and education resources concerning the implementation of the new ICD-10 codes, please http://uphsxnet.uphs.upenn.edu/ICD-10Project/
and login with your Penn Key. If you have any questions or concerns, please contact the Office of Clinical Research at firstname.lastname@example.org.
September 11, 2015
Attn: All CAMRIS Investigators/Coordinators
Subject: PBR Billing System
There will no longer be manual corrections made to time stamps that are recorded on the PBR billing system.
This means if you clock out past the allotted time you will be paying for that time. Starting and end times are shown to the left of the submit button.
If you need to enter text and don’t see the field ask the MR Tech for assistance.
If you forget to log out or face some other situation you MUST enter an explanation into the free text area at the bottom of the expense sheet. These entries will be reviewed and credited on merit.
September 4, 2015
Attn: MRI Research Community
Subject: MRI Research Scans
We are writing this memo to follow up on the OCR announcement that was distributed via email yesterday afternoon regarding MRI research scans. If you have an existing protocol that includes MRI scans that are conducted solely for research purposes and would like to move your existing protocol outside of Epic, we recommend the following:
Review your study design.
- If your study includes multiple scan sessions and you currently have subjects’ active on study with future MRI appointments, you will need to continue ordering through PennChart. If you chose not to follow this route, you will need to re-consent your active subjects with the new clause: Revise your Informed Consent Form to include the following clause: The MRI performed under this protocol is not for medical purposes, and the images are not planned to be interpreted by a physician.
- If your study includes one MRI scan session and your subjects are currently completed on study, you will need to consent all new subjects with the newly revised consent that includes the new clause: The MRI performed under this protocol is not for medical purposes, and the images are not planned to be interpreted by a physician.
You can continue the process of having your MRI scans order within the EMR for this study.
PLEASE READ THE ATTACHED CAMRIS TIP SHEET REGARDING THIS CHANGE. http://assets/user-content/documents/MRI Exam Categories_2015-Sep-3.docx
Also, PI, and BA’s: please forward this email to your research teams to ensure this message reaches all involved.
If you have further questions about this process please contact CAMRIS.
September 2, 2015
Attention: Research Community
Subject: MRI, US Research Scans
This memo provides guidance to investigators and staff on (i) when research orders for MRI and Ultrasound need to be placed in EPIC and (ii) when pregnancy testing is required prior to MRI. Please note this memo does not apply to CT, nuclear medicine or interventional radiology.
All MRI and US, scans that (i) are conducted as part of a clinical trial, (ii) require a clinical read, and/or (iii) require the use of Gadolinium, require an order signed by a licensed provider and must be scheduled through Radiant (the Radiology system) by calling 215-662-3000. Results will be placed in the subjects EMR. The standard IRB approved consent language is to be used.
MRI and US, Scans conducted solely for research purposes, that do not require a clinical read or storage of images on the Radiology PACs system, can be ordered and scheduled outside of EPIC by a member of the research team. No information about the scan will be entered in EPIC. In this situation scheduling occurs as described below
* MRI scans can be scheduled by blocking time on the CFN calendar:
* Ultrasound scans can be scheduled by calling Susan Schultz: 215-573-0972
The modified consent language to be included when imaging is being conducted outside of EPIC has been approved by the IRB and is as follows, "The (insert name of the imaging: MRI and/or US) performed under this protocol is not for medical purposes, and the images are not planned to be interpreted by a physician."
MRI and Pregnancy Testing:
Consistent with clinical care standards, pregnancy testing will not be required prior to conducting MRI scans for research purposes. Attestation of pregnancy will be accepted at the time of MRI screening. Existing studies, that currently include pregnancy testing prior to scanning, can be amended to remove the requirement now and be submitted to the IRB for approval. Alternatively the study can be amended at the time of the next IRB continuing review. If you elect not to amend the study until the time of the next IRB continuing review, CAMRIS will continue to supply pregnancy tests for the next 12 months.
Effective August 31st 2016, when a protocol requires mandatory pregnancy testing the responsibility will rest with the PI to ensure the testing completed.
If you have any questions, please do not hesitate to contact Dr. Schnall, Dr. Meagher, Kathleen Thomas, Radiology Clinical Research Operations Director or the Office of Clinical Research Staff at 215-746-8334 or email@example.com.
This information can also be found on the OCR website at http://www.med.upenn.edu/ocr/announcements.html
Mitch Schnall, MD, PhD
Chair, Department of Radiology
Emma A. Meagher, MD
Senior Associate Dean and Chief Clinical Research Officer
© The Trustees of the University of Pennsylvania | Site best viewed in a supported browser. | Site Design: PMACS Web Team.