Radiology Research Feasibility Assessment

To ensure that Radiology resources will be available for human research at Jefferson, protocols that requires imaging assistance must be submitted for review by the Department of Radiology. A formal request for review is initiated by completing the RadRequest webform that may be found on the Jefferson Office of Human Research Protection site. A complete log of all correspondences will be maintained by the Department of Radiology.

ATTENTION – Study Team Must Read Before Proceeding

All fields below should be thoroughly read, comprehended, and answered to the best of your knowledge. Failure to do so may result in extended reviewing time.
Informal or verbal requests for Radiology resources will not be acceptable.
Any updates to the imaging guidelines after this submission or Radiology approval will need to be resubmitted for evaluation.
The PIs should review the imaging protocol and be mindful of patients’ implant status and imaging tolerance.
Please e-mail the latest protocol version to [email protected] to expedite the reviewing process. Protocol submission is REQUIRED even for standard of care requests. For non-standard of care, please also submit the imaging manual.
For approval, please allow us two weeks for standard of care requests, and up to one month for non-standard of care requests.

Form Completed by:

Name: *

Your email address *

Phone Number: *

Section I: General Information

Protocol Title *

2-3 words to identify trial (keywords)? *

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

Principal Investigator: *

Principal Investigator Phone Number: *

Principal Investigator Email Address: *

Department

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

Yes

JeffTrial Number *

Has this study has already been submitted to the IRB?

Yes

If yes, please provide IRB Control Number below:

Section II: Study Details

For this study, patients are:

In-patient

Out-patient

Other

What phase is the trial in?

Phase 1

Phase 2

Phase 3

Not applicable

Other (please add info)

If 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 *

Section III: Imaging Details

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.). *

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

Yes

If you answer “Yes”, this means there is no questionnaire, no training, and no phantom imaging required. If the protocol requires ANY of the above, please check “No”.

Is there any phantom imaging or a volunteer imaging required? *

Yes

*If yes, you may be required to supply a volunteer for imaging.

If Yes, please specify the requirement?

Is there specific online training required for imaging team? *

Yes

If Yes, please specify the online training requirement?

Is there a questionnaire to be completed? *

Yes

If Yes, please list the questionnaire.

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

Yes

Unknown

Who is responsible for imaging charges? *

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)

Please enter grant number, if the study sponsor is responsible for charges.

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

PET

Radiography

Nuclear Medicine

Ultrasound

CT/PET - outpatient studies ONLY

MR/PET

Can you attest that you, as the Study Coordinator, have fully read the Imaging Trial requirements for this study? *

Yes

Name of the Study Coordinator who read the Imaging Study Training requirements: *

Date Read *

Section IV: Staff Resources

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

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

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 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

Section V: Additional Comments

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