Is this a new study or a modification of an existing study?
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New study
Modification
Is this study a NCI/NCTN cooperative group trial?
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Yes
No
Study Protocol
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full study protocol. If not available, the protocol summary
HS-ERA application (pdf of application)
IB for radiopharmaceutical
Pharmacy manual for radiopharmaceutical
Modification Summary/Form
PRA or MCA (if available)
Other Supporting Documents
Optional
Study Title
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Penn IRB Protocol Number
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UPCC Protocol Number (if applicable)
PI Name
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Please include credentials (MD, PhD, etc)
PI Phone
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PI E-Mail Address
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PI Department
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Anesthesiology and Critical Care Biochemistry & Biophysics Biostatistics & Epidemiology Cancer Biology Cell & Developmental Biology Dermatology Emergency Medicine Family Medicine and Community Health Genetics Medical Ethics Medicine Microbiology Neurology Neuroscience Neurosurgery Obstetrics & Gynecology Ophthalmology Orthopaedic Surgery Otorhinolaryngology Pathology & Laboratory Medicine Pediatrics Pharmacology Physiology Physical Medicine and Rehabilitation Psychiatry Radiation Oncology Radiology Surgery Other
select primary if dual appointments
Federal Industry Internal (Grant) Foundation/Non-Profit Professional Development Funds (ProDev) Internal (Other) Other
If Internal (Other), please name
Is this a Multicenter or Industry Sponsored Trial?
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Yes
No
Is a site qualification required?
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Yes No Not applicable
Nuc med qualification needed?
Site Qualification Documents
Nuc med qualification forms
Has an Imaging CRO been identified by the Sponsor?
Yes
No
If yes, please list the name of the Imaging CRO
* must provide value
Is there an increase in total number of participants?
Yes
No
If yes, describe the change in number of participants
Number of anticipated Penn subjects
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Modality involving radiation
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Please check all that apply
If other modality, please describe:
Timepoints of protocol CT imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Imaging Protocol: Please describe the image procedure details, including; contrast/non-contrast, area of scanning, length of scan, CTDIvol and/or DLP, dual and/or single energy, or any other pertinent information.
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Imaging Protocol: Please describe the image procedure details, including; contrast/non-contrast, area of scanning, length of scan and the frequency of scans per patient
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Imaging Protocol: Please describe the image procedure details, including; contrast/non-contrast, area of scanning, length of scan and the frequency of scans per patient
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Imaging Protocol: Please describe the image procedure details, including; contrast/non-contrast, area of scanning, length of scan and the frequency of scans per patient
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....). You may also upload a study calendar under Other supporting documents and refer to that for protocol timepoints
Are procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List non-SOC Research timepoints (number of timepoints per category)
e.g. CT Non-SOC x 3 (screening, 12 wk, EOT)
Imaging Protocol: Please describe the image procedure details, including; contrast/non-contrast, field of view, length of scan, type of fluoroscopy (DA, cine, pulsed), low dose/high dose/frame averaging, estimated total beam on time, or any other pertinent information.
Does this study have a general nuclear medicine component?
* must provide value
Yes
No
General Nuclear Medicine Procedure Type Requested
Please describe for Other
Timepoints of protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....)
Are general nuclear medicine procedures SOC?
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List Non-SOC Research timepoints for scans (include number of scans per category)
e.g. MUGA x 1 Non-SOC (screening)
Are general nuclear medicine scans standard clinical protocol for these procedures?
* must provide value
Yes
No
Unknown
e.g. Bone scan, MUGA, SPECT/CT
Imaging Protocol: Please provide a brief description including radiotracer if applicable (e.g. DAT) or radiotherapy drug.
Does this study have a PET/CT component?
* must provide value
Yes
No
PET/CT Scan Type Requested
Please describe for Limited Area
Please describe for Other
Timepoints for protocol imaging
Provide timepoints that imaging will occur per protocol (e.g. screening, baseline, wk 12....)
Are PET procedures Standard of Care*
* must provide value
All SOC
Mixed SOC and Non-SOC Research
All Non-SOC Research
*Standard of care determined by whether a standard patient would undergo the procedure regardless of study participation based on clinical practice for the condition
List Non-SOC Research timepoints (number of timepoints per category)
e.g. FDG PET/CT Non-SOC x 2 - (Screening, EOT)
Are these scans identical to the standard clinical PET/CT procedure for this scan?
Yes
No
Unknown
All aspects must match standard clinical protocol procedures, including scheduling on any scanner
Imaging Protocol: Please describe the image procedure, including the radio tracer (e.g. FDG), uptake time (time from tracer injection to scan), length of scan and the frequency of scans per patient
Planned imaging location - nuclear medicine
* must provide value
* PAH may not be an option for some imaging studies depending on the protocol requirements
RES: designated Nuc Med Physician will read images and dictate only an abbreviated safety report
Clinical report : clinical service will read images and dictate a standard report
Designated Nuc Med Physician for reports
* must provide value
Do images need to be uploaded electronically to the sponsor (or imaging CRO)?
Yes
No
If YES, does your team require staff to be set up with MIM access?
Yes
No
If yes, additional instructions will be provided
Is there technologist or other technical training requirements?
Yes
No
Which of the following will the use of diagnostic radiopharmaceuticals in this study be performed under?
* must provide value
If you select IND Exemption please submit an IND exemption request along with this application under other supporting documents or email to RRSC administrator at ehrsrhr@ehrs.upenn.edu
Name of FDA approved diagnostic radiopharmaceutical (e.g. FDG)
* must provide value
IND Exemption request form
Supplier of the diagnostic radiopharmaceutical
* must provide value
PENN Cyclotron (investigational radiopharmaceuticals or FDG)
Outside Vendor (for investigational radiopharmaceuticals)
Clinical Supply for SOC scans (other than FDG)
Name of investigational diagnostic radiopharmaceutical
* must provide value
Please provide IND or RDRC Number for diagnostic radiopharmaceutical
* must provide value
If "Other" please provide the IND number
* must provide value
Please provide name of IND holder or PI
* must provide value
Department of Radiology
Other
If "Other" please list name of IND holder or PI
* must provide value
Does the study involve investigational radiotherapy?
Yes
No
Radiotherapy drug name (include isotope)
* must provide value
If number is unknown you may enter "Pending"
Radiotherapy drug dose per administration (activity in MBq and/or mCi)
Frequency and number of cycles of radiotherapy
(e.g. 4 cycles, every 8 weeks)
Name of Outside Vendor (may list more than one if there are multiple possibilities)
Nuclear Medicine Authorized User Name
* must provide value
HUP Nuc Med - for FDA approved radiopharmaceuticals only PAH Nuc Med - for FDA approved radiopharmaceuticals only Jacob Dubroff Michael Farwell David Mankoff Ilya Nasrallah Daniel Pryma Paco Bravo Mark Sellmyer Austin Pantel Sophie O'Brien David McCarthy (Cardiac only)
If this radiopharmaceutical is under an IND or RDRC you must name a Nuclear Medicine Authorized User. If it is an FDA approved radiopharmaceutical you may choose a specific AU or HUP Nuc Med or PAH Nuc med. Please contact the NM committee administrator if you are unsure about how to complete this question
Special Procedures in Nuclear Medicine: Please describe any special procedures required to be done by nuclear medicine personnel during the protocol (e.g. blood draws, ECG, vitals) and timing of the procedures.
Will radioactive biosamples be collected for PK or other testing (blood or urine)?
Yes
No
If Yes, describe samples to be collected and any special handling or processing
Will radioactive biosamples need to be shipped?
Yes
No
Email
* must provide value
Phone
* must provide value
Please let us know if there is anything else we should consider when reviewing your protocol.
Please note that incomplete applications will not be processed.
Name of person completing application
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Email of person completing form
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