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
• Recruitment materials
(e.g., advertisements, screening forms)
• Federal grant application
(minus appendices and budget information)
• All applications
must be re-approved annually.
CAMRIS application includes:
• 3 page CAMRIS approval
form 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 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-investigational, not just
a "contact."
• All applications
must be re-approved annually.
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.
Click here for STANDARD fMRI CONSENT FORM WORDING
Click here to download
our Consent Form Template for fMRI studies
CAMRIS information is located at:
http://www.mmrrcc.upenn.edu/CAMRIS/
IRB information is located at:
http://www.upenn.edu/regulatoryaffairs/IRB.html
Office of Human Research
(OHR)
information is located at:
http://www.med.upenn.edu/ohr/
Click here for
Clinical Research Training in Humans (e.g., POR, HIPAA)
Scheduling of research patients is to be done as follows:
1) Research Coordinators establish and/or clarify existing patient medical
record numbers.
a. This can be done by calling Central Registration at (215) 615-2240 -
it is important to call even if the subject has a pre-existing MRN to have
it listed as "research."
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. When calling Medical Registration: 215-625-2240. They 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
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, IDX 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 assigned by CAMRIS during the approval process.
4) 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 "CAMRIS"
e. Diagnosis code “Radiology Research"
f. Don't forget to write down the Accession #
5) Research Coordinators should check with the MR Technologists to verify
their scheduled time slot in the V10 system. 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.
REVIEW OF IDX 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 IDX V10 scheduling discount code has been implemented. All investigators and coordinators calling Central Radiology Scheduling (215-662-3000) are to use "CAMRIS" as the designated "discount" code. 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 IDX 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 ex:MRPL (pelvis), MRAB (abdomen), MABI (abdomen with injection), BRBI (breast with injection), MRSP (spine), etc. etc. etc. If you are not too sure what your exam code should be..contact Norman Butler at 215-349-5298 or < mailto:reltubs@comcast.net >
4) When the scheduler asks about "location"
Scanner to be utilized "MR5" (HUP5) / "MR6" (HUP6) / "MRD1" (DEVON 3T) / "MRD2" ( DEVON 1.5T)