NEW APPLICATION REQUIREMENTS AND GUIDELINES

CAMRIS Applications
IRB/CAMRIS Concurrent Applications
Data Analysis Plan
MRI Billings
PRODEV Accounts
Radiology Reports
Contrast Prescriptions
Experimental Coils and Software

 

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ANIMAL STUDIES
a) completion of the 3 page CAMRIS approval form and MR protocol page.
b) copy of the study protocol and/or IACUC application form
c) copy of the IACUC approval letter
d) For all animal studies a copy of the "Animal Transport Letter" which allows transport of animals within the University System (obtainable from Infection Control Office 215-662-6995 )
e) attach a list of the potential risks and the steps to avoid them

For tech supported Animal studies: To be scheduled after all human scanning is done ( late afternoon/early evening) to prevent collisions with human subjects. Will be charged hourly rate scanner is in use.
For non-tech support Animal studies: must pay for the first hour via a funded account or a PRODEV account then subsequent hours of that same session can be "no cost" (note: a new day is a new session) To be done "after hours"

SPECIMEN STUDIES
A) HUMAN
a) completion of the 3 page CAMRIS approval form and MR protocol page
b) copy of the study protocol
c) copy of the "Claim of Exemption" from the IRB
d) attach documentation for obtaining the specimens. Note: If bringing in specimens from outside labs, a letter from Infection Control is required. Specimens coming from HUP's Pathology labs are considered "in-house" and can be scanned as such.
B) ANIMAL
a) completion of the 3 page CAMRIS approval form and MR protocol page
b) copy of the study protocol
c) copy of the regular animal form "A," as submitted to the IACUC, if as part of the protocol they will be euthanizing and harvesting tissues/organs/and body fluids from live animals.
d) or copy of the animal form "C,"as submitted to the IACUC, For investigators who want to use animal by-products ( fresh or frozen) obtained from other investigators. The Investigators may use tissues or individual organs of animals which were not exposed to infectious agents or chemical contaminants.
e) copy of the IACUC approval letter

ADDITIONAL NOTES:

EXPERIMENTAL COILS AND SOFTWARE must be approved prior to usage on the Siemens systems.
For approval of experimental coils and a serial number) contact Tom Connick
< rfmail1@mail.mmrrcc.upenn.edu >
For pulse sequence and software approval contact Larry Dougherty
< doughel@uphs.upenn.edu >

IRB/CAMRIS CONCURRENT APPLICATIONS from Investigators may be submitted to CAMRIS for review before their final submission to the IRB. Note: we are now listed on the IRB's FACE SHEET. Upon receiving a copy of the IRB approval letter and dated consent form, a MRI billing account will then be set up for your study. Note: all applications must be re-approved annually.

DATA ANALYSIS PLAN: Describes the investigator's plan to analyze the data such that a conclusion can be drawn. Looking for no specific details, but a plan for statistical analysis of the data to correlate with the purpose of your study and/or experiment involving human subjects. For small studies of limited risk, a short description of your analysis plan is sufficient while some of your more involved Drug studies may have up to 10 pages.

MRI BILLINGS
a) scan rates for government sponsored program grants is $425.00 per hour.
b) scan rates for Clinical Trials (Pharmaceutical Companies) is $575.00 per hour.
c) MRI IV contrast charges are $68.00 per 20 cc's

PRODEV ACCOUNTS are for 10 one hour slots. To be used within one year of approval date. If MRI contrast agents are to be used, PI must provide a source of funding. NO CONTRAST AGENT IS SUPPLIED FREE.

RADIOLOGY REPORTS are not provided as part of the Research Service. If you wish to have a report generated, you must make your own arrangements to have a Radiologist "on board" who will be responsible for the interpretation and dictation of a report.

 

revised: 8-15-06ak