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DEVON DRESS CODE updated 6-24-08

It is standard policy that all individuals must dress in appropriate clothing prior to being scanned in any of the DEVON Scanners: MRD1( 3T Tim Trio), MRD3 (1.5T Espree,) or MRD2 ( 1.5T Avanto). Please note: the DEVON facility is considered a HUP clinical facility and we must respect it as such.

1) All clinical research patients, controls and volunteers being scanned must wear gowns. Changing room and gowns available.
2) All TECHDEV investigators, approved users and support staff doing scanning without tech services must also adhere to DEVON's Dress code, but have the option of several additional choices.
a) Gowns: provided by DEVON center
b) Scrubs - Bring your own
c) Sweat clothes or "scrub-like" clothes that do not have zippers, clips, or ornamentation that may be magnetic - bring your own

Shoes must be removed before entering the scanner. Booties are available at the front desk of DEVON.

1) RADIOLOGY SCRIPTS 6-17-08 (UPDATE)

As of June 17th 2008: EVERY research patient to have a "script" for registration. All patients must report to the Dulles Radiology Registration area and sign in. Let the receptionist know this is a CAMRIS research patient and you will be processed right away. After processing you may then take the patient to your designated scanner. .

Registration will document arrival and status of patients and subjects
Registration will verify patient information in the IDX V10 system.
Registration will confirm accession number with each script

This applies to all clinical research subjects, fMRI subjects, PRODEV’s, normal controls, etc. etc. Does not apply to TECHDEV volunteers.

Notes:
The script to be filled out by the investigator and/or the Research Coordinator. Scripts can be given to the patient prior to exam or dropped off at the registration desk earlier in the day.
Fill in examinations required ( body codes), History Number ( MRN), Sex, Birth date, pertinent clinical data, physician, name and address of subject.
Physician must be a MD: either the PI or a co-investigator.
Under pertinent clinical data write in RESEARCH
Under type of insurance: write in CAMRIS
Write in your name and designation (HUP5/6, MRD1, MRD2) on the bottom of the script

2) CAMRIS vs FAMILY ACCOUNTS 3-18-08

Patients who are enrolled in clinical trials who are receiving MR scans that are considered standard of care, reimbursed through third party payers, using standard clinical protocols, do not need to have their scans/protocols registered through CAMRIS. These studies should be ordered and scheduled clinically as always.

Patients who are enrolled in clinical trials who are receiving MR scans (or any imaging study) that are considered standard of care, using standard clinical protocols, but that will be reimbursed through the grant budget (for example, sponsor requires that all imaging be done at a single institution with collection of scans for centralized review—thus study funding is to be used when necessary to ensure that patients may receive imaging here regardless of insurance coverage/capitation issues) do not need to have their scans/protocols registered through CAMRIS. For these studies, the department can establish a “family account” which will send the technical and professional clinical charges to the grant # indicated by the PI. Imaging will still be done per clinical routine, and radiology report will be performed as in #1 above.

For patients who are enrolled in clinical trials who are receiving MR scans that are considered standard of care, but that will be reimbursed through the grant budget, and for which the sponsor or trial indicates a specific scanning protocol or the use of a single scanner throughout the study, the PI should consider using the CAMRIS mechanism. While the family account mechanism can be used for imaging that is considered standard of case, the department cannot guarantee that a study performed on a “family account” mechanism will always be performed on the same imaging equipment, etc. The department does require a nominal fee per case for providing anonymized CDs of patient exams for clinical protocols.

For MR studies that are not considered standard of care (e.g. imaging on volunteers/control groups, repeat/additional patient baseline studies, additional patient studies during the course of therapy at time points not normally indicated clinically, or studies using novel imaging acquisition techniques) registration through CAMRIS is required. This applies even if the imaging protocol is “standard”. The guidelines for protocol submission are indicated below. PIs should recognize that the CAMRIS charges cover only the technical scanning itself, and that the PIs may be responsible for independently arranging for a Penn radiologist to perform clinical interpretations.

Additional contact information for family accounts:
Betty Lou Ditz betty.ditz@uphs.upenn.edu (215) 552-3028

Additional contact information for CAMRIS:
Alex Kilger alex.kilger@uphs.upenn.edu (215) 349-5470

3) WIPS: WORKS IN PROGRESS 3-17-08
Testing of new pre-product MRI imaging techniques for image quality Made available through Siemens Medical USA.

Submission of a 2 page application form to Abe Voohees <abram.voorhees@siemens.com > for approval and signature with copies going to Norman Butler < reltubs@comcast.net > CAMRIS for research applications and
to Beverly Farrar < beverly.farrar@uphs.upenn.edu > for clinical applications.

Abe installs the software: Only affects the 3 scanners in the devon building at this time

Every WIP technique prior to incorporation into a study must meet the FDA guidelines for minimal risks to the subject
Evaluation of each WIP technique will continue until the technique is either approved by the FDA or found to be of low quality and dropped.

TECHDEV
Need WIP request form and CAMRIS approval
Only to test sequences in the 1.5 and/or 3T environment. No data generated.

RESEARCH studies
Need WIP request form and CAMRIS approval
WIP can be incorporated into a research MR protocol. Data can be generated
Need the "experimental device clause" in the consent and in the study protocol
Case report/rating scale to be filled out for each study and submitted to Siemen's Abe Voorhees

CLINICAL studies.
For clinical faculty memebers interested utilizing experimental pulse sequences on clinical patients.
Need WIP request form and CAMRIS approval
Separate WIP consent must be signed by subject.
WIP is considered an "Add-on" to the clinical MR protocol. Data can be generated
Case report / rating scale to be filled out for each study and submitted to Norman Butler

4) OPTIONAL SERVICES 2-15-08

Neuroradiology, offers two optional "services" both now billable to your CAMRIS account.

a) Coordinator Services $50.00 per scan: Includes services by a MR Research Coordinator (i.e., scheduling, monitoring, visits/audits, database entry and documentation ) for any research clinical trial not covered or supported by a grant/sponsor.

b) Reader Services $50.00 per scan: Includes neuroradiologist clinical expertise and reader services for any research clinical trial not covered or supported by a grant/sponsor.

Body MRI now also offering the two optional “services” both billable to your CAMRIS account

a) Coordinator Services $50.00 per scan: Includes services by a MR Research Coordinator (i.e., scheduling, monitoring, visits/audits, database entry and documentation ) for any research clinical trial not covered or supported by a grant/sponsor.

b) Reader Services $50.00 per scan: Includes radiologist clinical expertise and reader services for any research clinical trial not covered or supported by a grant/sponsor.

For all questions regarding arrangements for coordinator and/or reader services contact Alex Kilger <alex.kilger@uphs.upenn.edu>

For all questions reqarding billing practices contact Laurie Cesaro <cesarol@uphs.upenn.edu> and/or Bill D'arcy <darcyw@uphs.upenn.edu> from our Radiology Research Business Office.

5) INDIVIDUAL SCREENING FORMS 1-26-08
All personnel ( investigators, Coordinators, technical support, etc.etc.) entering any magnet room is to have a signed INDIVIDUAL SCREENING FORM on record before entering. Hard copy forms are available by HUP5, HUP6, Devon1 and Devon2.
Note: This is a one time signing…May give it to Norman Butler and he will add it to a database of approved personnel.

6) TECHDEV DATA FORMS 1-25-08
Individuals wishing to use Mitch Schnall's technical development consent forms for both the 3 Tesla and the 1.5 Tesla systems need to be aware that screening and data forms must be filled out.
NOTE: forms are attached to the consents.

1) The first page contains demographics and a brief history: all questions should be answered in their entirety. Please check off either male or female and be sure to fill out the portion of the race demographics. All subsequent answers on the first page to be "NO" and remember that females of childbearing age must take a pregnancy test prior to participation. Urine pregnancy sticks can be made available by asking one of the technologists at the 3T or the 1.5T systems.

2) The second page evaluates your medical history and determines whether or not you can be included as a normal volunteer. In general, all answers should be NO. All yes answers must be acccompanied by a brief explanation.

3) The third page is a reminder list for individuals to read over and make sure that they do not have any of these specific items on their persons before entering the room. The list should be reviewed and signed by both the interviewer and the subject.

4) The fourth page deals with system specific modifications and documentation of any adverse events that take place during the course of your technical development imaging session. The RF coil used must be documented and if that coil is an in-house coil a letter of approval and/or a serial number must be given. Your TECHDEV project name is assigned through your primary investigator. Each PI has been given a specific project name and if you are unsure of that name contact Norman Butler and he will make it available to you. All non-product pulse sequences used for the session must be documented

CONSENT FORMS: The last page of the consent form should have a legibly printed name accompanied by the signature of the subject. The same applies to the authorized person obtaining consent.

All completed screening, data and and consent forms are to be placed into the "IN BIN" in Norman Butler's office immediately following the completion of the session.

7) RENEWAL POLICIES 1-14-08

<http://www.mmrrcc.upenn.edu/CAMRIS/human.consent.guidelines.shtml >

All research projects on our MR scanners must undergo yearly CAMRIS reviews. Investigators to submit a new application, a copy of the MR imaging protocol, a copy of IRB's request for continuing review and its progress report ,a copy of the consent, a copy of the data analysis plan, and a copy of the protocol summary. Notices to be sent out in a timely fashion

Also required: a copy of the IRB approval letter and the stamped consent when available.

There are 5 specific areas that CAMRIS specifically looks into (in both the consent and the protocol summary) relating to the MRI portion of the study.
a) pregnancy clauses
b) flying objects clause
c) experimental device clause
d) gad and renal disease clauses
e) targeted enrollments

Please note: CAMRIS and the online calendar expiration dates are the same as the IRB expiration date.

8) MULTINUC TIME 12-18-07

MULTINUC time is reserved for the following Blockley Hall Research Groups & investigators: Ravinder Reddy, Mark Elliot, Ari Bohrtakur, Jerry Glickson, Harish Poptani
These researchers are to enter themselves into the CfN calendar as alternates to indicate their intent to use a particular slot.
If no alternate sign-up is made 48 hours prior to a slot's time, then the HUP6 user community in general may sign up as an alternate for that slot, reserving it for their own use.

10) TECHDEV vs PRODEV: NOT THE SAME THING 12-10-07

TECHDEV ( Technical Development ): TECHDEV's are typically phantom experiments of limited scope. Limited human scanning is allowed to further access the results of experimental pulse sequences and/or coils. Not for acquisition of preliminary data. A global Human Use protocol and stamped consent have been made available under Mitch Schnall's IRB approval to use for technical developments. Scanning may be done by an approved user. TECHDEV time is free after 7 PM and on weekends.

Note: Because Mitch Schnall is the PI, he keeps all of the signed consents. Also, Mitch fills out his own yearly IRB Request for Continuing Review and all of the TECHDEV’s done over the past year are considered part of his total count.

PRODEV ( Protocol Development ): PRODEV accounts are departmental endowments available to nonfunded investigators who need MR slots and preliminary data (pilot studies) for grant submission, award applications and funding agencies that they hope will support their work in the future. The awards are generally allotted in blocks of 10 one hour slots ($4250.00). Investigators must provide their own study protocol and consent. They must maintain their own IRB approval and regulatory binder. Scanning must be done by a MRI tech. PRODEV time to be scheduled during day hours as per MRI tech availability.

10) IDX V10 REFERRING PHYSICIANS 12-6-07

Changes in “referring physician” status during IDX radiology scheduling have been upgraded to allow Radiologists involved with research studies as an Investigator or Co-investigator be the designated “referring physician”. Can only be in reference to research exams scheduled with RES, RNR or RESREPORT modifiers.

Updated list now includes: Mitch Schnall MD, Mark Rosen MD, Evan Siegelman MD, Laurie Loevner MD, Elias Melhem MD, Harold Litt MD, Drew Torigian MD, Ron Wolf MD.

If I’ve missed anybody, please let me know.

11) TARGETED ENROLLMENTS 12-6-07
The number of subjects to be recruited as part of your study needs to be stated in both the consent and in the study protocol
The number of MRI’s each subject will undergo for research purposes needs to be stated in both the consent and in the study protocol
The length of time each subject is to be in the study needs to be stated in both the consent and in the study protocol.

Please note: number of "targeted enrollment" as listed on the CAMRIS application, the IRB request for continuing review, the study protocol and the consent should all match.

12) IDX PHONE TREE 11-30-07
IDX Phonetree: is an automated system which calls patients the day before their scheduled exams, whether for MRI, CT, PET, MAMMO, US, etc, as a reminder of their upcoming appointments.

This Phonetree is now being modified to exclude all research subjects on MR5, MR6, MR3, MRD1, MRD2 and MRD3 (by using one of the 3 stated modifiers: RES, RNR or RESREPORT as an exclusionary factor) Any and all future calls to subjects will now only come from you.

13) BODY READER SERVICES 10-30-07
Only good for studies in which there is no grant supported radiologist already "on board" to read cases.
Reader services will be billed at $50.00 per exam (professional fee)
All investigators implementing this service to use RESREPORT modifier when scheduling in the IDX V10 system.
No " back tracking" of cases already done. Service starts the day of request.

Request slips may be faxed to Body Reading room at 215-662-6455
or placed in special bin located next to the teleradiology section.

Arrangements made through Alex Kilger < alex.kilger@uphs.upenn.edu >
Will require CAMRIS Application Packet modifications to set up the billing

14) PART TIME TECH COVERAGE 10-29-07
Part time coverage. We now have two techs ( Kelly Salvato and Joan Sporano) , both currently working part time for Beverly Farrar, and both available for "extra hours" as research techs for Norman. We are now hoping to open up some weekend slots to help ease the scheduling demands during the week.

15) POSTER REVIEW 10-25-07
Need to start looking at some of the posters/advertisements being made by our investigators for recruitment purposes..…Making sure they don't say that MRI involves "No risk"….when in fact there is "minimal risk"…etc. etc. <www.upenn.edu/regulatoryaffairs/human/guidance/recruitguide.pdf >

16) PRODEV ACCOUNTS (RENEWALS) 9-4-07
We currently have 22 PRODEV active accounts: 9 of them are 2-5 years old with little or no activity.

PRODEV accounts are for Investigators who need preliminary data ( pilot studies) for grant submissions. To be used within one year of approval.

For all extensions and renewals investigators will need to make a personal presentation to CAMRIS committee. (NEW)
a) Present a progress report of their work up to date
b) List the type of award and funding agency for grant submissions that will support this work
c) Indicate the status of the proposal ( in preparation or submission)
d) Indicate how the additional time and/or data will help your proposal
f) Submit a copy of the "Preliminary Results ( section C) of their NIH grant application.

Note: Currently exploring the possibility of offering “Coordinator services” …for those projects having difficulty “getting off the ground” …At $50.00 per study and billable to PRODEV monies. Anybody interested in such services?

17) WORKS IN PROGRESS CRF's 3-27-07
Note: A global Human Use protocol and consent form has been made available under Mitch Schnall's IRB approval to use for testing of WIPS on clinical scans.

WIP Case Report Forms (CRF)
a) A CRF must be available on each patient who signs consent with some demographics as per IRB "request for continuing review" standards.
b) CRF's are to be filled out by either the person doing the consenting and/or the investigator.
c) MRI clinical techs and support staff who have completed their POR's may consent the patients to be part of the investigative WIP sequence.
d) CRF should be attached to the signed stamped consent when filled out
e) Line D3, "event numbers" are designated numbers which appear on the consent ( for cross referencing the CRFs)
e) Box for collecting consents and their CRF's will be located in the Devon Center; large cabinet next to MRD1.
f) Investigators responsible for keeping their own records of which WIPS done on which scans.

two forms available:
a) one for onsite manual data entries ( for those who prefer to "jot" info at the site)
b) and one for on-line data entries ( for those who prefer the keyboard, pop-ups and returns)

18) CREATININE CLEARANCE LEVEL 2-28-07

CAMRIS Policy revision

RE; Creatinine clearance level modified from "less than 25" to "less than 30" may not receive Gadolinium.

Updated CAMRIS excerpt:
"Those with Moderate to Severe Renal Disease as defined by a Creatinine Clearance level of less than 30 may not receive Gadolinium based contrast agents as part of their study protocol. Note: they may undergo the MRI.... just cannot be administered Gad."

19) REVIEW OF IDX SCHEDULING TERMS 2-19-07

A) 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. .
1) RNR research no report
2) RES research with report generated by grant supported radiologist
3) RESREPORT research with report generated by Independent Neuroradiology Reader Services at $50.00 per exam

B) 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.

C) 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 >

D) When the scheduler asks about "location"
Scanner to be utilized "MR5" (HUP5) / "MR6" (HUP6) / "MRD1" (DEVON 3T) / "MRD2" ( DEVON 1.5T)

20) FDA AND GADOLINIUM ALERT 2-9-07

Recently we received an FDA ALERT regarding the use of Gadolinium in patients with severe renal disease. There have been several reports of serious, Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) following exposure to gadolinium based contrast agents.

Symptoms include: burning, itching, swelling, hardening and tightening of the skin: red or dark patches on the skin: yellow spots on the whites of the eyes; stiffness in joints with trouble moving or straightening of the arms, hands, legs, or feet: pain deep in the hip bones or ribs: and muscle weakness. Gadolinium deposits have been identified in skin biopsies of patients with NSF/NRD.

As per CAMRIS Policy:
Those with Moderate to Severe Renal Disease as defined by a Creatinine Clearance level of less than 30 may not receive Gadolinium based contrast agents as part of their study protocol. Note: they may undergo the MRI.... just cannot be administered Gad.( revised 2-28-07)

All investigators to start modifying their protocols to designate Severe Renal Disease as an exclusion critieria for contrast. .

Formula and calculators

Creatinine Clearance = [[140 - age(yr)]*weight(kg)]/[72*serum Cr(mg/d)

Example: Patient's age: 40 patient's weight: 72kg creatinine level: 2

a) Formula:
For Men

<(140-40 ) x 72 = 7200 > = 50 creatine clearance level.
(72 x 2 ) = 144

For Women Multiply by 0.85

< (140-40) x 72 = 7200 > x 0.85 = 42.5 creatine clearance level
(72 x 2 ) = 144

b) Online computerized calculations
<http://www.intmed.mcw.edu/clincalc/creatinine.html>

18) POLICY REVIEW: CONSENTING SUBJECTS 1-10-07
Under no circumstances....can a TECHDEV, PRODEV, normal subject, control subject, research subject, etc. etc. be scanned in one of our research scanners without a signed consent. This is considered a serious Protocol violation

Excerpt from PennManual.
Protocol Violations:
"Serious variances to the protocol have the potential to change the risk/benefit ratio, the validity of the study results, or a subject's rights or well-being. When such a variance occurs and prospective approval was not obtained, this is then considered a Protocol Violation."

"Examples of protocol violations include: subjects enrolled who did not fulfill eligibility criteria, failing to obtain informed consent, confidential information disclosed, enrolling subjects during a lapse in IRB approval, conducting unapproved research tests or procedures, and administering investigational medications in a manner not specified in the study protocol."

"The IRB should be notified of any protocol violations promptly after the violation is discovered. The investigator should include a detailed plan of how to prevent serious protocol violations from occurring in the future. If necessary, the IRB has the authority to intervene by terminating approval for the project or suspending an investigator for extremely serious or repeated non-compliance issues."

19) FAMILY MEMBERS and CONTROL GROUPS 12-14-06

Family members of faculty and/or staff can participate in low risk studies ( not TECHDEV) as normal volunteer/control.
Family members of PI and/or co-investigators can also participate in low risk studies but will require a third party witness signature on the consent.

As per Mitch Schnall 12-14-06

17) CLINICAL ADD-ONs 12-5-06
A clinical "add-on" is a mechanism by which extra pulse sequences and/or coils, may be 'added" on to a clinical study for research purposes. This involves use of clinical facilities and clinical tech support.

CAMRIS:
a) application form
b) review of study protocol and consent for CAMRIS compliance relating to flying objects and pregnancy
c) must have IRB approval letter and stamped consent

CLINICAL:
a) all additional sequences to be approved by Evan Siegelman.
b) must provide a copy of the extra sequences to be "added" to the Beverly Farrar and the clinical techs
c) must schedule during clinical time: bill to Insurance
d) Add-ons must not excede allotted timeslots on the magnet. Note: Clinical magnets are set up for 40 minute slots
e) PI is responsible for monitoring ADD-ON sequences

20) MEDICAL RECORDS REGISTRATION (5-23-06)
When calling Medical Registration: 215-615-2240. They will ask all this information, mainly for demographics, plus for emergency numbers and such.
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".

a) Name
b) Date of birth
c) Social Security Number
d) Address
e) Mother and father's first name ( identifying and verification of ID)
f) Doctor
g) Employment information ( if a student, may just say "student" )
h) Emergency contact
i ) Insurance information: for our purposes just say "Self-pay Research"

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".

..

last update 1-24-08ak