Today M-D-Y
Principal Investigator (PI) Name:
Proposed PI if early in development
PI Email Address:
* must provide value
Other Cardiology Endocrinology Medicine Neurology Neuro-surgery OBGYN Oncology-Irving Cancer Center Pediatrics Psychiatry Radiology Rheumatology Surgery
Please enter the PI department if it was not previously listed.
Is the study run by the PIs Primary department?
in other words, will the PIs Primary department be managing the study as a whole?
Yes
No
To be discussed
in some instances the PI may be in a different department to the department in charge of the study
Please enter the name of the department where the study sits if it is different from the PI's Primary department
Any other comments regarding the departments involved, describe here
Name of Person to Contact about this submission
eg. Study Coordinator, PI...
Email of Person to Contact about this submission
Enter the Working Title if the exact title of the project is not available yet
New Submission
Amended Submission
Project is still at developmental stage
What is the submission deadline (if applicable)
Today M-D-Y
Do you confirm that all activities in Radiology are limited to standard of care imaging and procedures, without any Novel/ research tracers, imaging or therapy or procedures ?
If any additional interpretation/ activities by Radiology are required , do not select YES to this question.
If you select yes, your survey submission is complete.
Remember to complete the Radiology Imaging Cost Estimate. This will be required to confirm each procedure is accounted for and invoiceable as needed.
Please use the link to submit the Imaging Cost Estimate https://radio-sftp.cpmc.columbia.edu/redcap/surveys/?s=H9K94F8DLN
Leave blank if this does not apply to your study
For your request, choose all that apply
Unless you can confirm all activities are as for clinical care, you will have to identify a collaborator in Radiology. (eg PhD, MD, physicist, etc)
choose all that apply
Describe Partnership with Radiology (Investigator & department)
Name of Radiology Investigator or Partner
* must provide value
Describe activities in Nuclear Medicine
Nuclear Medicine Activites: Who is your collaborator in Radiology? Please provide their name
* must provide value
Describe activities in Interventional Radiology
Activities in Interventional Radiology:
who is your collaborator in Radiology? Please provide their name
* must provide value
If study involves MRI:describe activities
write in all Divisions
MRI: Site Qualification activities:
choose all that apply
write in all Divisions
If a Radiology Investigator's study:which Division(s) of Radiology is/are involved
write in all Divisions
Radiology Investigator: Describe activities
Radiology Investigator: what other help is needed
choose all that apply
Radiology Investigator: describe other help that is requested
choose all that apply
Ultrasound, Breast Imaging etc: Describe activities
Type: Other: Describe activities
Interventional Radiology Support
What kind of support is required? Choose all that apply
Interventional Radiology Support: Radiology CRC
Outline required activities
Interventional Radiology Support: CRC
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Interventional Radiology Support: Blood Draws
Outline required activities
Interventional Radiology Support: Blood Draws
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Interventional Radiology Support: ECGs
Outline required activities.
How many timepoints required on one day?
Interventional Radiology Support: ECGs
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Interventional Radiology Support: vital signs
Outline required activities
How many timepoints required on one day?
Interventional Radiology Support: vital signs
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Interventional Radiology Support: IR Radiologists special role
Outline required activities
eg procedure, administer therapy
Interventional Radiology Support: IR Radiologists special role
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Interventional Radiology Support: Other
Outline required activities
Interventional Radiology Support: Other
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support
What kind of support is required? Choose all that apply
Nuclear Medicine Support: Radiology CRC
Outline required activities
Nuclear Medicine Support: Radiology CRC
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support: Blood Draws
Outline required activities
Nuclear Medicine Support: Blood Draws
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support: ECGs
Outline required activities
How many timepoints are required on one day?
Nuclear Medicine Support: ECGs
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support: vital signs
Outline required activities
Nuclear Medicine Support: vital signs
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support: NM Radiologists special role
Outline required activities
eg procedure, administer therapy
Nuclear Medicine Support: NM Radiologists special role
For how many visits will this be required?
provide any pertinent info
Nuclear Medicine Support: Dosimetry, Gamma counting or similar
Outline required activities, and how many visits
Nuclear Medicine Support: Dosimetry, Gamma counting or similar
For how many visits will this be required?
name the visits, eg C1D1, C1D8
Nuclear Medicine Support: Other
Outline required activities
Nuclear Medicine Support: Other
For how many visits will this be required?
name the visits, eg C1D1, C1D8
PET Center Activities
What kind of activities are required? Choose all that apply
PET: Small Animal studies:Choose activities
PET: Small Animal studies: who is your collaborator in Radiology? Please provide their name
* must provide value
PET: Human subjects:Choose all that apply
PET: Human subjects:who is your collaborator in Radiology? Please provide their name
* must provide value
PET Center : RadioChemistry
What kind of support is required? Choose only one
RadioChemistry: PET Tracer production
Choose tracer isotope from list below
C11 Tracer F18 Tracer Ga Tracer I don't know type of tracer Other
isotope or select I don't know
RadioChemistry: C11 Tracer production
Choose tracer from list below
[11C]-Raclopride, [11C]-PHNO [11C]-MDL 100907 [11C]-6-OH-BTA-1 (aka PIB) [11C]-CUMI-101 [11C]-DASB [11C]-PBR28 [11C]-ABP688 [11C]-Glutamine [11C]-Harmine [11C]-UCB-J [11C]-ER176 [11C]-MPC6827 [11C]-Vorozole
isotope or select I don't know
RadioChemistry: F18 Tracer production
Choose tracer (isotope) from list below
[18F]-DTBZ F18 [18F]-FLT [18F]-FPEB [18F]-THK5351 [18F]-FDOPA [18F]-MK6240 [18F]-FES [18F]Fludeoxyglucose (FDG) [18F]Sodium Fluoride (NaF) [18F]-MEFWAY [18F]-FAP -2286 (HKG301)
isotope or select I don't know
RadioChemistry: Ga Tracer production
Choose tracer (isotope) from list below
[68Ga] Dotatate (NETSPOT), [68Ga] PSMA-11 (ILLUCCIX)
isotope or select I don't know
PET Tracer - if you selected Other, write in the name that you know
write in any pertinent details
If you selected I don't know, please contact PET Center: email
Write in the name that you know the tracer by
Tracer Production by PET Center - timepoints
at what timepoints for each subject
eg screening, post Cycle 2, End of Study etc
Production by PET tracer - how many subjects?
expected enrollment, over how many years
Radiolabelling of PET Tracer that Sponsor provides:
Choose tracer from list below
Names Other
RadioChemistry
Radiolabelled PET tracer - how many subjects?
expected enrollment, over how many years
PET RadioChemistry: Site QualificationProvide details
Sponsor will provide PET Tracer in Injectable (Ready to Use) form:
Choose tracer from list below
[F-18]-MK-6240 [18F]Fludeoxyglucose (FDG) [18F]Sodium Fluoride (NaF) [68Ga] Dotatate (NETSPOT) [68Ga] PSMA-11 (ILLUCCIX) Other
PET: Site Qualification activitiesChoose all that apply
PET Large Animals Will the Sponsor provide the tracer in an injectable form ?
Note: Large Animal scans will be scheduled at the end of the day to allow for required prep and cleanup
Yes
No
PET Large Animals If the Sponsor will provide the tracer in an injectable form : provide details of the tracer
provide description of tracer
PET Large Animals if tracer is to be produced by the PET Center, choose the isotope :
FDG C11
provide description of tracer
PET Large Animals if tracer is to be produced by the PET Center, provide more details of tracer
provide description of tracer
PET Large Animal: Site Qualification activitiesChoose all that apply
Large Animal site qualification- other: describe activities
PET Center: Clinical Research Support
What kind of support is required? Choose all that apply
PET: Small Animal protocol
Do you have an approved or submitted protocol ?
Please contact Andrei ( am3355 ) to discuss info that needs to be included in the protocol.
Yes
No
PET: Large Animal protocol
Do you have an approved or submitted protocol ?
Please contact Andrei ( am3355 ) to discuss info that needs to be included in the protocol.
Yes
No
PET: Enter the Animal Protocol Number
eg IACUC number
PET: What Animals do you plan to use?
Choose all that apply
PET Animal: Do you require PET/CT or CT only study?
PET/CT CT only
Animal PET tracer / probe
choose from list below
F18-FDG F18-FDOPA C11-ER176 C11-UCBj Ga68-PSMA Other / custom tracer (please provide name and link to the published source)
Animal Tracer: Other If Custom Tracer is required, choose from below
PET tracer (ready to be injected dose) is provided by the customer Custom PET tracer needs to be developed / produced by the PET center (requires extra cost & time)
Animal Tracer: OtherIf Custom Tracer is required, please provide name and link to the published source
Animal PET Scans: Choose how many from the list
Single
Multiple
PET Animals: Do you need animals back after the scan
Yes
No
Animal Tissue: Do you need animal tissue dissected/ fixed
Yes
No
Dosimetry: Do you need dosimetry data for individual animal tissue
Yes
No
What Type of Animal Tissue for Dosimetry?
PET Radiochemistry: Radiolabelling of PET tracer
Describe
Describe Other activities in PET Center
PET tracer - are phantom scans required?
Describe what is required
how often?
Preparation of RadioTherapy dose:Provide details of required dose
How many subjects
Industry
NIH
Foundation
Internal (Columbia)
RFMH
Other
Duration of project (years)
you may write pending if you do not have this information currently
If this protocol was previously under a different IRB number and/or PI, please provide the previous IRB number and/or PI name here.
If you have already submitted a Radiology Imaging Cost Estimate, what is the Record ID?
eg Record ID 4-###
Expected start date for Dept. of Radiology involvement
Today M-D-Y
Expected end date for Dept. of Radiology involvement
Today M-D-Y
How many subjects do you expect?
How many visits for each subject?
Does your project involve any of the following: • Patent filing and IP management • Technology marketing • Technology license agreements • Material and data transfer agreements • Confidentiality agreements, Software "express" licensing for a Technical project • Inter-institutional collaborations • Executives in Residence (XIRs)
Yes
No
Tech Ventures
Name of Grant Administrator (if applicable)
your department's grant person who will work on the budget
Email of Grant Administrator (if applicable)
Yes
No
Please provide sponsor name.
The Study must provide funding for the Dept. of Radiology. Confirm if these services will be added to the initial budget, or with an amendment
* must provide value
initial budget
an amendment to the budget will be requested
funding is pending
If "other" is selected, please provide more details.
Protocol Upload
* must provide value
How many files do you need to upload?If you are using more than one modality, please upload a manual for each modality Please note: - If you have multiple files you can zip the files into 1 folder and upload the folder here. - For de-identification requests , please use the REDCap Radiology Cost Estimate request Project
1 2 3 4 5 6
Imaging Manual/Instructions (if available) Upload
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Imaging Manual/Instructions (if available) Upload 2
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Imaging Manual/Instructions (if available) Upload 3
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Imaging Manual/Instructions (if available) Upload 4
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Imaging Manual/Instructions (if available) Upload 5
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Imaging Manual/Instructions (if available) Upload 6
If you are using more than one modality, please upload a manual for each modality
Please note, if you have multiple files you can zip the files into 1 folder and upload the folder here.
Please upload any pertinent documents
Please provide additional comments or questions.
Submit
Save & Return Later