Submit applications to the IRB and CAMRIS
IRB application includes:
• Signed IRB
face sheet and attachments
• Cover Letter to
IRB
• Patient
Oriented Research (POR) Training Certificates for
all involved in study
• Protocol Summary for
study subjects
• Full Protocol description
• Informed Consent Forms
• Copy of HIPAA consent
form (if not contained in ICF)
• Recruitment materials
(e.g., advertisements, screening forms)
• Federal grant application
(minus appendices and budget information)
• All applications
must be re-approved annually by IRB.
CAMRIS application includes:
• CAMRIS approval
form (online in Redcap) and MRI protocol page with Cover Letter
• Copy of FACE SHEET
and STUDY PROTOCOL as submitted to the IRB
• Copy of IRB approval
letter and copy of the dated informed consent form
• For all NCI/NIH
grants, a copy of the "Study Plan" that
was submitted for the grant application
• Protocols must include a Radiology Department Sub-Investigator or Co-investigator,
not just a "contact." This person much be an MD with a faculty appointment
in Radiology.
• All applications
should be re-approved annually ONLY if any changes have been made to the protocol's MRI sequences or if level of risk has changed.
.
You may submit to both the IRB and CAMRIS at the same time and forward
the approved consent form to CAMRIS when it is returned from the IRB.
CAMRIS has a new website in 2016! Please be sure to bookmark this new link:
http://www.med.upenn.edu/camris/
Click here to read the "out of epic/PennChart" tipsheet for MRI research scanning (Sept. 3, 2015)
Click here for a CfN fMRI pulse sequence list
IRB information is located at:
http://www.upenn.edu/IRB/
The Center for Human Phenomic Science (CHPS and formerly called the CTRC/GCRC) information is located at: https://www.med.upenn.edu/chps/
Office of Clinical Research
(OCR)
information is located at:
http://www.med.upenn.edu/ocr/
Click here to read the revised registration guidelines for MRI and Ultrasound studies
Click here for Clinical Research Training in Humans (e.g., HIPAA & CITI POR).
Individuals should also complete the MRI Safety Trainin Module in Penn's Knowledgelink.
Need CITI Protection of Human Subjects Training and it is not yet on your
Knowledgelink profile? Click here. Also, click here for the CITIGuide.
Don't Forget to establish a Reseach Billing Number (RBN) for each protocol which requires EPIC scheduling. Click here for the application portal. For the official users guide to RBN's, click here. For the Dept. of Radiology's Manual of Procedures for ordering and scheduling Radiology studies using EPIC, click here.
NEW: Click here for PennChart help/procedures for non-clinical fMRI scans on HUP6.
Scheduling of clinical research patients (studies using PennChart) is to be done as follows:
1) Research Coordinators establish and/or clarify existing patient medical
record numbers.
a. This was previously done by calling Central Registration at (215) 615-2240. However,
effective June 30, 2014, this patient registration line will be discontinued. If your department/division does not have a designated central registration/scheduling staff, and you currently use this service, you can call Radiology registration at 215-662-3000 and the schedulers can assist with obtaining a Medical Record Number (MRN) for your research subject.
b. All information for the patient should be updated if they have not
been scanned in the last 30 days or have had recent changes to demographic
information.
c. The Radiology registration staff will ask all this information, mainly for demographics, plus for emergency numbers and such. No Patient will be scanned with inaccurate information.
1) Name
2) Date of birth
3) Social Security Number (note, on the new patient registration form it is ok to list 999-99-9999 if you don't have a SS#) Please click here for the form.
4) Address
5) Mother and father's first name (identifying and verification of ID)
6) Doctor
7) Employment information (if a student, may just say "student")
8) Emergency contact
9) Insurance information: for our purposes just say "Self-pay Research"
Finally at the end when they ask for insurance information.....just say "self pay research" which allows them to fill in the blanks (for demographics). When it is time for the MRI study, our own HUP5/6 Techs will then enter the research billing code thus overwriting the "self pay annotation". If the Medical registration people will not accept "self-pay research" due to changes in their own policies, give them the name of the subject's own insurance company. And again, when it is time for the MRI study, our own HUP5/6 techs will then enter the research billing code thus overwriting the Insurance company annotation.
Note: As per FDA standards on record keeping, reports are considered a "source documentation".
2) Research Coordinators must contact MR Technologists for available time
slots or use the web-based scheduler.
a. HUP6 time slots are available on-line
b. HUP5 time slots are allocated via phone or E-mail correspondence at this
time.
3) MR Techs will allocate the time necessary for the study and verify this with the Research Coordinator. This only provides a tentative time slot to be filled through the following steps with Radiology scheduling. Research Coordinators must have the correct and current billing code assigned to their specific research study available. Any questions about the Billing Code to be used must be reconciled prior to scheduling as the ability to reschedule will be eliminated. The billing code is the IRB protocol number.
4) Research coordinators must be properly trained by OCR (the Office of Clinical Research) for access to the PennChart system at UPHS. Coordinators are able to use the online EPIC system and link the subject to the research protocol per the OHR policies. Click here for an overview of the billing process.
5) Research Coordinators will call central radiology scheduling at (215) 662-3000 extension 1 with the
following information. If this information is not given the patient will
not be scheduled:
a. Correct and Current Patient MRN and Demographics
b. Date and Time of Exam
c. MR Scanner to be utilized (MR 6 in most cases)
d. Research Billing Code - the code is your study's 6 digit IRB protocol number (formerly was your CAMRIS account name). Note, your study must have an established RBN (research billing number) or the scan can't take place.
e. Diagnosis code - Tell the scheduler it is “Radiology Research" utilizing "V70.9" Also note that for most fMRI studies, the exam code for routine head only no contrast MRI is: "MRHDUZ"
f. Don't forget to write down the Accession #
6) Research Coordinators should check with the MR Technologists to verify their scheduled time slot in the scheduling system. Research coordinators must also appropriately check the subject into the Radiology Dept. outpatient service as outlined below-see #5). Please note that If your subject's MRN does not match with the MRN associated with the Accession Number, you will not be allowed to scan that subject.
7) Please note that CAMRIS/Radiology is now using the Path BioResource system for MRI billing procedures.For the manual, click here.
REVIEW OF SCHEDULING AND TERMS:
Radiology scheduling: call 215-662-3000 extension 1
Scheduler will ask for date and time of study, Name, MRN and/or birthdate of subject.
1.) When the scheduler asks about "Modifiers"....this references that this is a research study and designates whether or not this study gets a report. There are currently 3 modifiers. .
a. RNR research no report
b. RES research with report generated by grant supported radiologist
c. RESREPORT research with report generated by Independent Neuroradiology Reader Services at $50.00 per exam
2) when the scheduler asks about "Billing"..
A scheduling discount code has been implemented. All investigators and coordinators calling Central Radiology Scheduling (215-662-3000) are to use the study's IRB protocol number (also have your research billing number available) as the designated "discount" code. (Prior to EPIC, the discount code was simply "CAMRIS".) This will indicate that this is a MRI Service Center Research Study and will be recognized as such.
Please be aware, this applies for scheduling in the system only. Investigators to continue to use their individual MRI Service Center Account codes for the HUP5, HUP6 and Devon 3T and Devon 1.5T research bookings, scanning protocols, charges and online calendars.
3) When the scheduler asks about "Exam Code"
Exam code: for example: MRHDUZ (head only, no contrast). If you are not too sure what your exam code should be, contact Shannon Long at 215-349-8553 or mail to: Shannon.Long@uphs.upenn.edu
4) When the scheduler asks about "location"
Scanner to be utilized "MR5" (HUP5 1.5T) / "MR6" (HUP6 3T) / "MRD1" (DEVON 3T) /
"MRD2" ( DEVON 1.5T AVANTO) / "MRD3" (DEVON 1.5T ESPREE) / "MR7" (Stellar-Chance 7T)
5) Checking a subject into Radiology Dept. for their scheduled research MRI:
On day of the scheduled scan, study personnel should check their research subjects in at the Radiology Reception desk located on Ground Dulles Bldg. in HUP. There you will sign a check in sheet with the subject's name, DOB, etc. and wait to be called to the registration desk. You will be asked to fill out the MRI safety form for the subject via a tablet. Once checked in, proceed to the MRI scanner with your subject.
to view the current Radiology SOP on this topic as of December 2011. This final step before the actual scan session is especially important now that EPIC has been implemented by UPHS. Subjects must be shown as "arrived" in the EPIC system.
If you have any questions about the process, please contact Shannon Long for further instructions.
Phone: 215-573-9765 Email: shannon.long@uphs.upenn.edu