Protocol Development
Investigators must apply to the protocol development committee and gain approval for funding before a study will be reviewed by CACTIS. To apply for protocol development funds, contact Kathleen Thomas, Clinical Research Operations Manager.
Once protocol development funds are approved, investigators may submit the appropriate CACTIS application for CACTIS review.
Investigators seeking PRODEV accounts need to list the type of award and the funding agency that will support the work in the future. CACTIS will provide time on the CT scanners and charge the radiology PRODEV account as long as the following conditions are met:
- The investigators are actively seeking funding. The status of your research proposal (preparing or submitted) should be specified upon submission for each potential funding source.
- The study is not for industry-sponsored research. CACTIS must comply with the university and hospital accounting procedures. For industry-sponsored studies, no research may be conducted until all accounts have been established and the sponsoring company has provided the initial payment as outlined in the study's legal contract. PRODEV may not be used to start a project "early". PRODEV may be used to collect pilot data, which may lead to an industry-sponsored study [so long as the sponsor is not initially involved].
- PRODEV slots are to be used within one year of the approval date.
- The investigator must be able to cover certain costs:
- Technologist’s time (if needed after normal hours, an overtime rate applies)
- CT contrast agents
Scheduling Procedures
All human research studies are to be conducted between the hours of 7:00 am and 4:00 pm. It is the responsibility of the study team to recruit subjects, even if radiology coordinator services are utilized.
All volunteers must be scheduled according to instructions provided by the CACTIS Coordinator.
Animal Studies
- All requests should be made at least one week in advance and include:
- Date and time for animal research
- Amount of time required per case
- All IACUC documentation should be completed, including the animal transit letter.
- Only personnel who have their certification in radiography/fluoroscopy are permitted to operate the CT scanners.=
All animal/specimen/phantom scheduling requests must be sent to the CACTIS Coordinator.
Contact: Lisa Angilletta, Clinical Research Coordinator
lisa.angilletta@pennmedicine.upenn.edu
More on Animal Studies
Human Study Subjects
Once an investigator’s protocol has full approval, and the BEN account number for the research study has been forwarded to CACTIS and confirmed by the investigator’s department business administrator, the CACTIS Coordinator will email instructions for patient scheduling.
Please Note: When using the CACTIS service center, a family account does not to be created for the CT portion of the protocol. However, if the study requires other radiology exams (i.e., chest x-ray) a family account will need to be established for the other studies.
All CACTIS billing is done through the CACTIS Coordinator, not the hospital. Therefore, correct scheduling is essential. The billing/discount/research code for scheduling all CACTIS patients is "CACTIS". Failure to utilize this code will result in the hospital system billing the patients' insurance for the study. To avoid billing errors email the CACTIS Coordinator all patient information prior to the study date to allow for patient entry into PennChart.
The CACTIS Coordinator will need notification of all patients scheduled under your study to ensure proper billing by the third Friday of the month.
More on Human Studies
Technical Development
Due to the radiation exposure incurred with CT scans, only animals, phantoms or specimens may be scanned for this type of research.
In most cases, a CT technologist will be required to operate the CT scanner and technical time is only made available when a technologist is available. All animal studies require a technologist or radiologist to operate the CT scanner.
Investigators using the scanner for specimen or phantom studies, without a CT technologist, must provide a copy of their certificate of operation in fluoroscopy and undergo training in proper use of the CT scanner. The CACTIS staff will maintain these certificates.
Submission Process
Technical development projects are reviewed on a case-by-case basis. All researchers intending to perform studies under the technical development protocols must submit a request to CACTIS in the form of a letter describing the nature of the technical development. This should include:
- A brief description of the study protocol
- Equipment to be used
- Any unusual risks
The appropriate animal or specimen application form should accompany the letter.
Animal research protocols must have IACUC and CACTIS approval. A list of approved technical development projects is kept in the CT department.
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