No, the BRIC is not appropriate for research projects or clinical trials where the imaging exams need to be included in the patient/subject's medical record. All imaging exams that are done through the BRIC are stored in a separate research PACS system which is not connected to the BWH LMR.
When you are budgeting for study “subjects” the Imaging Core will provide more flexibility to the investigator. The Imaging core is not tied to the predefined scanning that is used for patient care, and can be customized to the investigator’s study design/protocol. Also the direct cost of Imaging Core scans are generally lower priced than a patient care equivalent.
B. When budgeting for the Imaging Core, the expense is budgeted as a direct cost in the “other” section of the budget and comes fully loaded with IDC. If for any reason you had to switch from “subjects” to “patients” the rebudgeting would work in the investigators favor. However if the line item had been originally budgeted as patient care, and the investigator decides that they would like to use the Imaging Core, the rebudgeting works against the investigator. Patient care is not awarded with IDC, and the imaging core expenses would have IDC associated with them.
In the case where you are submitting an NIH proposal that has a cap on total cost, it may seem more expensive to use the imaging core, because the scans which are generally lower priced than a patient care equivalent, do bear overhead, making the total cost of the scan more expensive.
Since the Corporate sponsored Clinical Trials have a Total Direct Cost base, the determining factor will be the subject population. If subjects are “patients” and the information needs to be recorded in their medical record, then patient care charges will be applied. If the trial requires healthy volunteers or “subjects” that are not under care requiring the information to be on their medical record, the Imaging Core may be preferable. In most cases Industry Sponsored Clinical Trials should be budgeted as Patient Care. Industry Trials could have a combination of patient care and Imaging Core.
On the Imaging Core website.
No, while the technology is available to choose where to store the images, for the first year of the Imaging Core, all images will be stored in the research PACS system only. However, if the subject’s scan is found to have a significant finding, with proper consent of the subject, the research scan could be moved to the clinical PACS system if the subject becomes a patient and is treated at BWH.
No, if using pricing through the Imaging Core, all scheduling must take place through the research instance of Percipio for proper tracking and billing.
No, the decision to use the Imaging Core is up to the PI of the research study, in conjunction with approval by the IRB
There will be a clinical Radiologist read of all scans completed using the Imaging Core, this is included in the pricing. No clinical report will be included in the subject's medical record (if you need this, then you should not be using the Core). If the Radiologist sees a significant finding, he/she will contact the PI and it will be up to the PI to get permission from the subject to contact their PCP to report the finding. The PI will need to help the subject find a PCP if they don’t have one.
The subject research record number (RRN) will be generated from the Percipio scheduling system and assigned to the subject to ensure anonymity. The RRN will get assigned when the patient is registered in Percipio. If a research subject is followed longitudinally in a study, each time they are scheduled in Percipio they will be scheduled with the same RRN. Each new exam will have a different accession number assigned to it but the RRN will remain the same (just as an MRN would).
The RRN is not the same as the study subject ID assigned in each study, the RRN will be used to schedule the subject in the Percipio system. It will be up to the research coordinator to keep a confidential internal record of subject names, study IDs and RRNs according to IRB standards.
The Imaging Core pricing includes a technologist during regular business hours. For human research scanning after hours/weekends, the research project would have to pay for a technologist to be present, or have a BWH MD be present. The technologist would most likely need to be paid time and a half if they are a full time employee of BWH. A physician will be present during scanning during regular clinical hours.
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