Policies

CSIC General Policies

All research studies that utilize imaging services at Emory’s Center for Systems Imaging Core (CSIC) must adhere to Emory’s Office of Research Administration policies governing human subject and animal research and must have an approved IRB, or IACUC, protocol.

To initiate CSIC core services, the Principal Investigator (or study coordinator) must complete the applicable Study Application Form and provide all required supporting documents. Protocol profiles are not added to the CSIC scheduling system until the application form and all required documents are received. The study protocol will be reviewed by applicable CSIC program director/technologists to confirm that CSIC can support the study's imaging requirements. Additional radiation safety documentation is required for protocols utilizing PET and microPET imaging. The study eNOA must be awarded and project SpeedType provided to CSIC for billing before protocols will be onboarded.

As a service core, CSIC charges a room occupancy time (ROT) rate for all imaging equipment use. Additional fees for radiopharmaceuticals produced by CSIC’s Radiopharmacy, or other add-on services used in support of study imaging services, are added to monthly invoices as applicable. The current CSIC rate table is available online and rates are subject to change annually.

Imaging Facilities Access and Use Policies

CSIC’s facility access and use policies were established to assure equitable support to the various Emory investigator study teams that utilize Core imaging services. However, the center’s goal is to work with investigators to look at specific needs, assess options, and offer flexibility where possible and within Core, ORA, and EHSO policies and safety guidelines. 

Parking Access

CSIC does not provide parking validation at our imaging facilities. Investigators/study coordinators are responsible for coordinating parking arrangements to support imaging service center appointments.

  • Parking decks are available for study team members/study participants to use for CSIC imaging facilities at Emory University Hospital, Emory Brain Health Center at Executive Park, and the PET/MR facility at Winship Cancer Institute. Applicable parking fees apply.
  • CSIC’s main HSRB-II imaging facility has (6) reserved CSIC research visitor spaces just across from the center’s G100 exterior suite entry door.
    • Due to simultaneous appointment times for the center’s various imaging equipment at HSRB-II, the visitor spaces are reserved for study participant use. Study coordinators are asked to use other Emory parking options since parking space at HSRB-II is not guaranteed.
    • Visitors at CSIC's HSRB-II facility are provided a day pass to place in vehicle dashboard. Emory Parking Services enforcement staff will issue citations to anyone parking in CSIC reserved spaces without the CSIC-provided day pass.
Facility Access

CSIC imaging facilities are restricted access to assure safety and security protocols and to maintain the privacy of human subject study participants.  

  • All investigators, study team members, and study participants who enter CSIC imaging facilities do so under the supervision of CSIC imaging services staff and must be escorted to imaging suites on the day of a scheduled appointment.
  • Only CSIC personnel or approved affiliated faculty that have technical innovation development agreements will be provided card access to CSIC’s imaging facilities.
    • For CSIC’s HSRB-II facility, a temporary visitor card is provided to the investigator or study coordinator who will be onsite for a scheduled appointment to facilitate access between the reception area and the restricted imaging suite corridor. For other CSIC imaging facility suite locations, the technologist or operator at those sites will meet study team members at the suite entry door to provide access.
  • Due to limited space/occupant load for our imaging equipment control rooms, we ask that study teams limit the number of team members present for scheduled appointments.
PI Study Supplies/Equipment

Space within CSIC’s facilities is prioritized to meet the core’s internal operational, service, and support needs. CSIC is not able to provide onsite storage space for investigator supplies or study equipment due to space constraints and liability. Exceptions to this policy will be reviewed on a case-by-case basis and granted only under limited circumstances for temporary storage needs. Investigators that are granted approved exceptions to temporarily store items within CSIC facilities do so at their own risk and will be asked to sign a temporary storage agreement to acknowledge that CSIC is not responsible for any loss of, or damage to, those items.

Facility Use 

All CSIC imaging suite control rooms, consent rooms, or support lab spaces used by study teams for scan appointments must be left clean and study team supplies/equipment removed when a scan is completed. CSIC does not provide biohazard waste disposal services for investigator study teams. Study teams are required to follow EHSO guidelines to safely remove and dispose any biohazard waste generated at imaging appointments.

Appointment Scheduling & Cancellation Policies

Imaging Service Appointment Scheduling 

CSIC’s online scheduling system, “DaySmart,” is used to request imaging scan appointments for CSIC's 3T and 7T MRI scanners. For PET/CT scanner appointments, and pre-clincal 9.4T/11.7T MRI and microPET/CT scanners, the technologist or technician will coordinate appointment requests (see below for processes). A User Account will be established for the PI of record at the time a protocol is onboarded into CSIC's system. Instructions for accessing the CSIC online scheduling system, including User ID and Temporary Password assigned, will be sent to the PI after a protocol is onboarded. In compliance with the Federal CFR requirements governing human research and closed systems, a user ID and Password to the Core’s scheduling system is set up and provided only to the study Principal Investigator. 

For PET/CT imaging service appointments, the study team member will coordinate PET/CT appointments directly with the PET/CT Technologist who will add them to the scheduling system once the appointment day/time is confirmed. This process is needed to arrange PET scans around days in which radiopharmaceuticals required for the scan can be produced/delivered. Appointment requests remain in Pending status until all required documents for the imaging service are received for the scheduled study participant. The PET Requisition form, signature page of the ICF, and the Radiotracer directive must be received 48-hours after the pending appointment is requested in order to confirm the appointment. The appointment status in the CSIC scheduling system is updated to Confirmed once all required documentation is received. Pending appointment requests will be canceled if required paperwork is not received within 48 hours after submitting an appointment request in order to release the time for other protocol appointment scheduling.

For MRI imaging service appointment requests, the PI (or delegated scheduler) will request an appointment day/time in CSIC's scheduling system. Appointment requests remain in Pending status until all required documents for the imaging service are received for the scheduled study participant. The MRI Requisition form, signed ICF, and the MRI screening form must be received 48-hours after the pending appointment is requested in order to confirm the appointment. The appointment status in the CSIC scheduling system is updated to Confirmed once all required documentation is received. Pending appointment requests will be canceled if required paperwork is not received within 48 hours after submitting an appointment request in order to release the time for other protocol appointment scheduling.

For pre-clinical MRI and micro-PET/CT imaging services, an initial meeting is required with CSIC's 9.4T/11.7T MRI scientist/operator, or micro-PET/CT technician, to review imaging procedure. Appointment requests are then submitted directly to the scanner operator/technician who will confirm the requested day/time and book the appointment in CSIC's scheduling system. 

CSIC Cancellation Policy 

CSIC requires 24-hour advanced notice to cancel scheduled imaging service appointments. Appointments cancelled inside the 24-hour window/or on the day of appointment, or where the participant is a "no-show" will incur a 50% fee for the service appointment scheduled. Radiopharmaceuticals that are ordered from third-party sources for PET scans at CSIC cannot be canceled on the day of the scheduled delivery. PI studies will incur the additional dose/deliver charge from that third-party vendor in addition to the CSIC 50% cancellation fee for the PET imaging appointment. If the CSIC Radiopharmacy has produced the radiopharmaceutical dose for a scheduled PET imaging service, the PI study will be billed for that dose if CSIC is not notified to cancel appointment within 24-hours of the scheduled appointment date.

  • Exceptions for Late Cancellation/Fees Policy
    • PI study not billed for PET imaging appointment for a dose production failure by CSIC's Radiopharmacy (dose production fee is also waived).
    • PI study not billed for PET imaging appointment for a dose production failure by third-party source vendor. Charges from the third-party vendor may apply - PI study member must contact vendor directly to discuss waiver of vendor fees.
    • Late cancellation fees are waived for CSIC's imaging services when extenuating circumstances warrant an exception. The MRI, PET/CT, or other CSIC imaging service technologist will provide information to the CSIC Operations Manager if a waiver is warranted. 

Incidental Findings Policy

Principal Investigators, or co-Investigators, are responsible for reviewing all research tests and imaging studies performed at CSIC. All incidental findings of potential medical significance uncovered by procedures on human subjects enrolled in research studies in which imaging services at CSIC are used must be reported. Such procedures include, but are not limited to, positive serum pregnancy tests, abnormalities on other bloodwork, and abnormalities or questionable findings on imaging studies. The CSI technologist will report any incidental findings noted on participant images to the CSIC Medical Director, Dr. Ranliang (Ron) Hu, via the CSIC Incidental Findings (Medical Referral) Report. The completed form will be maintained by CSIC with the study protocol’s documentation. Any questions concerning the clinical importance of an incidental finding should be directed to the CSIC Medical Director. Any incidental findings noted by Principal Investigator, or his/her designee, when reviewing imaging data should be reported as well to the CSIC Medical Director. The Principal Investigator of the study is responsible for reporting these findings to the Institutional Review Board (IRB) and any other applicable party.

If the abnormality is determined to be of potential clinical significance by the CSIC Medical Director, the subject (or subject’s representative in cases in which proxy consent was obtained for the research study) must be informed of the test result and follow up recommendations, as applicable. The information may be provided by the study Principal Investigator, co-Investigator, and/or the CSIC Medical Director. All subjects informed of a finding of potential significance will be offered a referral to their own physician or a physician of their choosing. If subject has no physician to provide, an appropriate referral will be provided.