Radiology Research Feasibility Assessment

In order to ensure that radiology imaging equipment/resources will be available for human research at Jefferson, research protocols that require radiology assistance with imaging should be submitted for review by the Department of Radiology. The request for review is initiated by completing a webform that may be found on the Jefferson Office of Human Research webpage. A complete log of all imaging research requests and responses will be maintained by the Department of Radiology to facilitate imaging research on campus.

Note: Radiology will provide a clinical report on every study (as per department policy) to the requesting physician or PI. Any standard imaging procedure, non-standard imaging, post-processing, measurements, case report form, data transfer request, or non-routine radiological interpretation required for the study must be specified on this form, or they will not be provided when patients are imaged for the study.

Form Completed by:

(A copy of your responses will be emailed to the address you provided.)

Name: *

ResearchTitle *

Your email address *

Phone Number: *

IMPORTANT INFORMATION: Informal/verbal requests for equipment availability and study prices will NO LONGER be acceptable.

A formal request for review MUST be submitted by the initiating investigator PRIOR to submission for IRB approval, or any time information is required about availability and/or cost of imaging for a specific study/proposal.

Has this study has already been submitted to the IRB?

Yes

If yes, please provide IRB Control Number below:

Section I: General Information

JeffTrial Number *

Indicate which of the following:

Initial Submission

Amendment/Renewal Submission

Principal Investigator: *

Principal Investigator Phone Number: *

Principal Investigator Email Address: *

Protocol Title

Department

Is the PI the author of the protocol/study? *

Yes

Study sponsored by * Please enter grant number

Who is responsible for imaging charges? *

Section II: Study Details

For this study, patients will be:

In-patient

Out-patient

Other:

What phase is the trial in?

Phase 1

Phase 2

Phase 3

Not applicable

Other:

REALISTIC estimated number of patients to be seen at Jefferson Radiology *

Estimated number of radiology visits per patient at Jefferson *

Estimated start date of study *

Estimated end date of study *

Please list all Jefferson locations where the study will be performed *

Synopsis: Provide a brief (2-3 sentences) lay-language synopsis of the study *

Please briefly (1-2 sentences) identify specifically what the Sponsor/Principle Investigator is looking for on the imaging exam (why the study is being requested, what specific issues need to be addressed in the radiology report, etc.). *

Are there any special instructions or specification for conducting or interpreting the images? *

Does the study require any phantom imaging prior to approval?

Yes

Unknown (If Unknown, please reach out to sponsor)

Identify all Radiology modalities for which imaging is required for the study:

PET

Radiography

Nuclear Medicine

Ultrasound

CT/PET - outpatient studies ONLY

MR/PET

Is contrast required for study? *Please note, double dose contrast is not permitted

Yes

Unknown

Is the TJUH standard clinical imaging protocol acceptable for this study?

If the TJUH standard clinical imaging protocol is not acceptable, please specify your imaging protocol requirements that deviate from our standard protocol, and specify on what pages these requirements appear in your study protocol:

Section III: Imaging Data

Identify if additional Radiologist support for this study is required:

Dual Reads

Blind Reads

Utilizing specific measurement tools

3D volumetric evaluation

RECIST

RANO

modified RECIST

Other

Not applicable

Section IV: Staff Resources

Has a radiologist with knowledge of the protocol been identified as a co-investigator?

Yes

Radiologist name (if applicable; if not applicable, type N/A) *

Radiologist Phone Number (if applicable; if not applicable, type N/A) *

Radiologist Email Address (if applicable; if not applicable, type N/A) *

Clinical/Regulatory Research Coordinator name (if applicable; if not applicable, type N/A) *

Clinical/Regulatory Research Coordinator's Phone Number (if applicable; if not applicable, type N/A) *

Clinical/Regulatory Research Coordinator's Email Address (if applicable; if not applicable, type N/A) *

Technical, sponsor or imaging vendor contact name (if available): *must have knowledge of the protocol *

Technical, sponsor or imaging vendor Contact Phone Number (if applicable; if not applicable, type N/A) *

Technical, sponsor or imaging vendor Contact Email Address (if applicable; if not applicable, type N/A) *

Section V: Additional Comments

Please provide any additional information you deem applicable to our assessment of the feasibility of your study: