Name of person completing this form
Today Y-M-D
if applicable
New Submission
Modification/revised
Renewal
CACTIS Upload Instructions
CACTIS Upload Instructions
CACTIS Upload Instructions
You will need to upload the following research documents numbered 2 through 5 (as applicable) for the CACTIS review:
Please addend all files for upload by adding the investigator's last name and the IRB number before each document title. Use xxxxxx if IRB number is not available.
Example of original file title: "Protocol - Safety and efficacy of Spirituous-X001 in subjects with Pulmonary Fibrosis"
Example of adding investigator's name and IRB # before the file title for CACTIS upload: "SMITH-102030-Protocol -Safety and efficacy of Spirituous-X001"
2. IRB HS-ERA application or Research Study Protocol Summary
3. Research Study Full Protocol
4. Consent Form(s) - must be same version submitted to the IRB, does not need IRB approval prior to CACTIS review. One clean copy is acceptable. See the CACTIS website for required consent form language.
http://www.uphs.upenn.edu/radiology/research/labs/cactis/consent-forms.html
5. CT Protocol - imaging guidelines and lab manual if provided for biopsy procedures (you must submit all specific guidelines and site qualification forms, technologist training information, etc., if a custom CT scan protocol is being used)
For investigative CT contrast agents or non-departmentally approved CT contrast agents, the drug brochure (IB) or package insert for FDA approved contrast agents must also be submitted.
6. Lab manual (only if requested)
7. Other documents as needed
Brief description of the study protocol
Brief description of purpose and type of CT scan requested
Study Coordinator (this should be the person to be contacted if the CT department has questions on the day of the CT)
Radiology Faculty Member involved with this research
Contact/consult only
Sub-investigator
Other
Yes
No
NIH/NCI Grant
Industry Sponsor
ProDev
Other
Please provide an explanation for "other"
26 digit BEN Account #
Account number must be received by CACTIS prior to full approval. Contrast is not included in PRODEV accounts and will be billed to the above 26 digit account number.
Business Administrator Contact
Business Administrator Phone
Business Administrator Email
PI Signature:
(By signing, the PI acknowledges that the information provided to CACTIS is accurate to the best of his/her knowledge and that CACTIS will deduct the cost of the CT scans, and/or other services from the above account if using the service center for billing.)
Has this study been approved by the IRB?
Yes
No
Pending
Other
Today Y-M-D
Today Y-M-D
9. Please upload a current copy of the IRB approval
Please upload a current copy of the dated consent form
Approval will be withheld pending the receipt of the IRB approval letter and dated consent form.
Has this study been approved by Radiation Safety?
Yes
No
Pending
Other
8. Please upload a copy of the radiation safety approval letter
A copy of the radiation safety approval letter must be on file prior to full CACTIS approval
Does the project involve the testing of investigational drugs or devices?
Yes
No
Does the protocol require optional or mandatory biopsies for research which may need CT guidance or other imaging guidance?
Yes
No
If yes, submit a separate application to the Clinical Imaging Core: https://is.gd/clinicalimaging
Type of CT study (example: high resolution chest CT)
Radiology CT exam (study) codes:
(can be filled out by CACTIS)
Contact: Lisa Angilletta, CACTIS Coordinator, 215-662-4595 or Laura Posey, CT Manager)
Are you using IV contrast? (cost: $25 per administration)
Yes
No
Are you using oral contrast? (cost: $10 per administration)
Yes
No
List the CT location(s) UPHS site(s) where research CT scans are to be performed:
example: Penn Presbyterian, PCAM, PAH, HUP
How much scanner time will be necessary per session? Most CT's are completed within one 1/2-hour session. Biopsy procedures and oral contrast studies may take 1 hour or longer.
Describe CT scan schedule per patient according to protocol
Are there any limits to the scheduling availability of the subject?
Yes
No
Is the CT Imaging Protocol Custom or HUP/Perelman Standard?
HUP/Perelman Protocol
Custom Sponsor Protocol
Will studies need to be placed on a CD-ROM?
Yes
No
CDs for CACTIS service center accounts: Images will be de-identified by the radiology research clinical imaging core at no additional fee. Requests must be sent to Lisa.Angilletta@pennmedicine.upenn.edu within 24 hours of imaging and the CD request will take about 1 week to process.
sFTP accounts: Your sponsor may provide you with software that allows de-identification and sFTP uploading of images from your personal computer, but you may still require a CD to do this. The CIC (Clinical imaging core) may be able to assist you with sFTP set-up and training for a fee of $100. Contact Kathleen Thomas or Tom Ferrara for more information. The transfer of imaging data from Penn to off-site imaging management companies is the responsibility of the investigator and the study personnel.
CDs for non-service-center accounts: You may request CDs at the ground floor radiology imaging file room. The cost of burning images to a CD is $5 per CD, and you must set-up an account with the radiology imaging library. Account set-up takes two weeks, contact the radiology file room or Cathy Oliva of IOD via cathy.oliva@uphs.upenn.edu for an application. Note: the file room only puts the case number on the CD labels, make sure this is OK with the sponsor. The CIC core can process CDs for you, but the cost is $25 per CD.
Does your study require a report?
Yes
No
If yes, is the report to be documented in the medical record?
Is the report to be documented only in the research files?
(When a research report is only to be documented in the research files, you should discuss this requirement with a radiologist.)
Radiology reports are not automatically provided as part of the research service. This cost is not included as part of the CT scan. If you would like to have a report generated you must arrange this with the radiologist on your study or use one of the reader fees. In some protocols, it is more beneficial to have only one radiologist read all of the research exams for consistency in the reporting. Compensation for this effort is negotiated separately between the radiologist and the PI. It is strongly recommended that reports of research images be recorded in the medical record, but there are times when you need a report that is only documented in the research record. This should be discussed with a radiologist.
Special evaluations or measurements that are research-study specific, require that a radiologist be part of the research study team, and he or she must be listed as a sub-investigator.
Radiologist responsible for image evaluation
Reader Service Fee
The reader service provides a routine clinical report and/or a report when screening for incidental findings are required. It will generally not provide research-study-specific measurements if they are beyond what is typically included in a routine clinical report. The reader service may not be used when research-specific evaluations or measurements are required per the protocol.
Policy: A radiologist must review all research CT scans for incidental findings when the images are of diagnostic quality and could reveal incidental findings that are unexpected and unrelated to the research question.
When may the reader service be used?
A. When a patient is under active treatment at Penn and the images are being sent off site for analysis by the research team, a report for incidental findings by a Penn radiologist is required.
B. When a patient is not under active treatment at Penn, but is in a research study and is not receiving similar imaging for cancer or other conditions and the research images are of diagnostic quality that could reveal unexpected incidental findings, then a report for incidental findings is also required.
Who reads for the reader service?
Any radiologist reading on the day of the exam, based on the anatomic reader sections listed below.
Will this study use the reader services?
(Any radiologist reading on the day of the exam will read for the reader service, based on the anatomic sites selected below.)
Yes
No
Which reader service will be needed? Please check all that apply.
Total Anticipated Enrollment
Inpatient
Outpatient
Both
Will pregnant subjects be excluded from this protocol?
Yes
No
If yes, then it is the responsibility of the study team to determine and document in their records non-pregnancy. The CT technologist will only ask if there is a possibility of pregnancy.
CACTIS no longer requires urine pregnancy test 24 hours prior to the CT scan if the study team is already performing these tests to exclude pregnancy such as is common with new drug studies, chemotherapeutic agents, etc.
If the protocol does not include pregnancy as an exclusion, then a pregnancy test is required 24 hours prior to the CT scan to rule out pregnancy. CACTIS excludes pregnant women from research studies because of the possible harmful effects to the fetus from the x-radiation.
Is it possible that the patient will have motor or mental difficulties? If yes, this may requiring monitoring by research staff. Explain below if research staff will not be required to monitor the subjects.
Yes
No
Will the patients need monitoring*?
*Patient monitoring is the responsibility of the study team.
Policy: The CT Staff will NOT monitor study patients once they leave the CT scan room. All patients receiving IV contrast must remain in the department and be monitored for at least 30 minutes post contrast to rule out delayed contrast adverse events.
Patients that need monitoring for other reasons will need a research staff member to be present for the CT scans.
Yes
No
If yes, explain the monitoring that will be necessary and who will monitor the subject and record any adverse events post CT scan or CT procedure
Do you need radiology research staff to assist with this monitoring requirement? There is a fee for this service.
Yes
No
Contact Kathleen Thomas for rates
Does your consent form have the standard language required for CT scans, IV contrast, biopsy risks, pregnancy, etc.,? Refer to the CACTIS website.
Consent form language and more information may be found on the CACTIS website:
http://www.uphs.upenn.edu/radiology/research/labs/cactis/
Yes
No
Unsure
Visit the website listed above or contact the CACTIS coordinator (215-662-4595)
CT Contrast Agents:
Standard CT contrast agents currently used at HUP/Perelman
1. IV contrast agent used at HUP: ISOVUE 370, cost $25/per injection
2. Oral contrast agent used at HUP: Redicat2, cost $10/per single use
3. Other
Will the following contrast agents be required?
IV contrast HUP/Perelman: ISOVUE 370
Yes
No
Oral contrast agent used at HUP/Perelman: Redicat2
Yes
No
Yes
No
if yes, please list the name and manufacturer
Is this contrast agent experimental?
Yes
No
List the name and manufacturer of the agent:
Please upload the investigator brochure if available
Will the CT technologists need training?
Yes
No
If yes, describe type of training and how much time is needed for this.
Are site qualification forms and/or CT phantom/test images required?
The cost is $150 per phantom scan or test image scan
Yes
No
Does your protocol require that the same CT scanner be used for all follow-up CTs?
Yes
No
Are you submitting a custom CT protocol?
Yes
No
Routine Clinical Protocol
Custom Protocol
Please provide parameters through the questions below. If your study includes a separate scanning protocol for the CT, please fill in the below information and attach a copy of the scanning protocol to this application.
IV contrast injection rate
Is standard post processing required?
Note: post-processing, including sagittal or coronol multi-planar reformatting, etc., is done automatically on the CT console. Custom protocols must be loaded on specific scanners; this is determined at time of CACTIS review.
Yes
No
I don't know
List the reconstructions:
Are additional reconstructions required?
Yes
No
Please provide an explanation
Any additional post-processing will be charged at a separate rate. This rate must be negotiated and signed off on prior to the study start date.
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