Technical Development (TECHDEV)

Technical development is the devising of protocols for new techniques in a CT environment. The idea is that these new techniques may one day be used in a clinical setting. In view of the radiation exposure involved with CT scanning, these protocols may not be done on humans. Animals, phantoms or specimens are reviewed on a case per case basis. Due to the regulatory climate at the University, CACTIS must adopt procedures to document protocol adherence, adverse events and activities performed under these protocols. In order to comply with the IRB recommendations, the below guidelines have been instituted for performing human studies under these protocols.

• 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 (no more than 1 page necessary). This should include a brief description of the protocol, equipment used and any unusual risks. A list of approved technical development projects will be kept in the CT department.
• Investigators performing research under the technical development IRB protocols will be required to submit a brief progress report to CACTIS yearly to document progress of their research.
• All investigators using the scanner without a CT technologist present must provide a copy of their certificate of operation in fluoroscopy. The CACTIS staff will maintain these certificates.

back to top

---

Protocol Development (PRODEV)

Protocol development accounts are available to investigators who need preliminary data for future grant submission. Investigators seeking PRODEV accounts will need to list the type of award and funding agency for grant submission that will support this work in the future. CACTIS will provide ten one hour scanning slots at no charge as long as the following conditions are met:

1. The investigators are actively seeking funding. The status of your research proposal (preparing or submitted) should be indicated upon submission for each potential funding source.
   
2. 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 issued 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. NO CONTRAST AGENTS ARE SUPPLIED FREE.

back to top

---

Archival Procedures

This standard operating procedure is applicable to any CT imaging procedure on the SIEMENS SENSATION64 scanner located on the ground floor of the Dulles building at the Hospital of the University of Pennsylvania. These standards pertain to all individuals performing these scans in the CT section.

Overview

This SOP is intended to provide direction and information about conducting consistent, HIPPA compliant data storage and retrieval for Investigators performing studies in the CT facility.

Definitions

Study is the overall set of images reconstructed during a session of CT scanning. There are three types:

• Human Study - Images generated while scanning a patient or normal volunteer during a session. These studies can be one of two sub-types:
  • Anonymous Trial Study - These studies require no information to be generated on the header information.
  • Routine Trial Study - These studies require the header information to contain pertinent patient identifying information.
• Animal Study - Images generated scanning an animal on the CT systems
• Phantom or Specimen Study - Images generated scanning ex-vivo tissue or a prepared substance or object.

Header Information - Information entered into the CT system specifying demographics or other information about the subject being scanned.

PACS (Central Archive) - Picture Archiving and Communicating System is the standard central archiving system.

CD-ROM - Write only CD archival. Investigators must provide their own CD's.

MRN - Medical Record Number- This is an 8-digit identification number used for patient identification and tracking throughout the University Hospital System.

DOB - Date of Birth

HIPAA - The Health Insurance Portability and Accountability Act addresses the security and privacy of health data.

DICOM - Digital Imaging and Communication in Medicine

Raw Data - data that is taken and stored on the disc in some other format that does not enter it as an image in the image database.

Information Requirements

• All Patients must have an established MRN. No person will be scanned without this number. To establish this number call Central Registration (215)-615-2240.
• All animal research must contain identifiers for both the ULAR number and Investigator.
• All scans are documented as entries in the logbook.

Entry of Patient Information

All human studies are entered as routine studies. All appropriate patient information is entered into the appropriate fields. Anonymous header information is applied to the subject data fields after the original data is placed on CD-ROM and sent to PACS.

Animal Studies must have information entered in the header, which allows identification of the animal scanned and the investigator managing the session. No entries in the header fields for Animal Research can be in a form that may be seen as human subject data. Any questions about this issue are handled through the technologists. If you are uncertain what is acceptable the technologists can assign identifiers.

Personnel Qualifications

All individuals operating within the CT environment will be trained Radiologic Technologists or approved users recognized by CACTIS. All approved users must supply a copy of their radiography/fluoroscopy operators certificate for the CACTIS files.

All individuals responsible for entering, copying, or transferring Human Study data will have an understanding of HIPPAA regulations pertaining to the data transfers as set forward by the University of Pennsylvania and HUP. These guidelines can be found on the Office of Human Research (OHR) website.

Archival for CT Scanners

All data scanned by technologists are sent to PACS. All Human Studies are verified within the PACS. It is the responsibility of the PI to provide CD's for personal archiving. The technologists can send the study to the radiology file room for CD burning if this cannot be done at the scanner, however, the CD’s will not be de-identified.  For research studies requiring anonymization of patient information, CACTIS has a technologist available, however, due to the amount of research protocols that require this task, please allow one week per subject for your de-identified CD.  For information on another option for anonymizing data please contact Melissa Myers.

Investigators are responsible for their Animal Research Data. The same procedure as above can be followed for animal studies. Phantom and Specimen archival is the responsibility of the investigators as well.

Raw Data

All raw data archival is the responsibility of the investigator unless otherwise arranged through CACTIS. No raw data will be stored on the systems. Raw data found on the systems can and will be deleted.

Filming

Filming is available for images acquired on the research scanner at an additional charge for the film and technologist's time. Please contact Melissa Myers for filming charges at 215-349-5891 or melissa.myers@uphs.upenn.edu.

Data Records and Management

Header information entered into the scanner must be specific to each animal (e.g. animal ULAR number) and cannot be in a form that the central archive can register as a patient. CT is not responsible for animal research studies going to PACS. The investigator's name must appear in the header information. Header information, operator, and investigator's name must be entered into the system logbook. Data from a study are not kept on the system disc. No films are generated for any animal research study.

Quality Control and Assurance

Quality Assurance of the system is done though routine Preventative Maintenance done by the CT manufacturer (Siemens). Records of this preventative maintenance are located in the CT department.

Archival problems that arise when Technological support is not available can be routed through the SIEMENS uptime service. The number is posted in the control area of each scanner.

Anonymization of a CT Exam for Research Purposes

Sponsors often request the CT exam images to be transferred to them as part of the study data collection. All images must be de-identified prior to leaving UPMC. The following procedure has been introduced to accommodate such requests. De-identification is part of the CACTIS charge for research protocols that are using the service center. Protocols using hospital billing services (family account) will have a service charge of $25.00 per CT scan for anonymization. Non-CACTIS users must apply for this service prior to study start.

CACTIS accounts procedure (charge: free)

1. Fill out the “Request for CD” form located on the forms page
2. Bring the filled in form and a blank CD to the CT reading room and give it to one of the CACTIS techs (Curtis or Scott)
3. Please allow up to one week for de-identification

Family account procedure (charge: $25.00 per CT exam)

An account must be established through CACTIS prior to any de-identification requests can be made.

1. Apply to CACTIS using the “Image Anonymization Account Request” form. This is an expedited submission and does not need to go on the committee meeting agenda.
2. Once approval is granted, follow the above procedure.

This service is ONLY for CT exams. All other radiology exams must be de-identified through their specific radiology section of origination. back to top

---

Scheduling Procedure

All human research is to be conducted between the hours of 7am and 4pm. 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 the CACTIS instructions that will be supplied by Melissa Myers.

Human Subjects

Once your protocol has full approval, and the BEN account number for the research study has been forwarded to CACTIS and confirmed by your department's business administrator, Melissa Myers will email you instructions for patient scheduling.

PLEASE NOTE: WHEN USING THE CACTIS SERVICE CENTER, A FAMILY ACCOUNT DOES NOT NEED TO BE SET UP FOR THE CT PORTION OF THE PROTOCOL. However, if your study requires other radiology exams (example: chest x-ray) a family account will need to be established for these other studies. All CACTIS billing is done through Melissa Myers not the hospital and because of this, correct scheduling is essential. Patients have received hospital invoices due to incorrect scheduling.  The billing/discount/research code for scheduling all CACTIS patients is “CACTIS”.  If this code is not utilized, the billing will go thru the hospital system and the patients insurance will be billed for the study.  To avoid billing errors email Melissa Myers all patient information prior to the study date and she will check the patient entry in IDXrad. She will need notification of all patients scheduled under your study to ensure proper billing by the third Friday of the month.

Animal Studies

1. Contact Felicia Jefferson and Melissa Myers via email requesting a date and time for animal research. Please provide the amount of time necessary per case. All requests should be made at least one week in advance.
2. All IACUC documentation should be in order including the animal transfer letter.
3. Only personnel who have their certification in radiography/fluoroscopy are permitted to operate the CT scanners.

All scheduling requests must be made in writing. NO EXCEPTIONS!!!

back to top