How do we order these research studies?
- After IRB approval and funding for a research study, any imaging study can be ordered through the electronic medical record at Lucile Packard Children’s Hospital Stanford.
- The SPECTR study initiation/consultation service can aid with how these orders are placed.
How does billing work?
- Once the IRB and funding for echocardiograms are approved for a prospective study, the echocardiograms are billed by associating the echocardiogram order with the research study.
- For the convenience of the investigators, this ordering protocol will ensure that the patient is not billed, and only the research PTA is charged.
- For retrospective studies, analysis of echocardiogram images is charged per echo and not handled through Epic.
- Invoices for analyzed studies are sent monthly to the PI
- Guidance for study import/transfer from outside institutions
What if there is a clinically important finding?
- In the event that a clinically important finding is discovered by a sonographer or physician, we will contact the PI of the study immediately to ensure patient safety.
Whom should I contact for consultation/ initiation of SPECTR services?
- A consultation with the Core Lab Manager and the Co-Directors early in the process will help facilitate research and direct resources accordingly.
How does the researcher make an IRB?
- The Core Lab Team can supply sample IRB templates that can be applied to prospective and retrospective research projects that can be modified to fit the needs of the current investigation.
How does the researcher anonymize and store imaging studies?
- In partnership with the robust IT services in the Moore Children’s Heart Center, all research echocardiograms and vascular studies can be stored in Research Server for convenient and easy access.
- The studies are partitioned away from clinical studies to avoid confusion.
- For research echocardiograms obtained prospectively, all images acquired would bear no personal health information when designing the study protocol.
- These studies can be stored on a physical disk or transmitted to another institution.
- For retrospectively obtained clinical studies, the images can also be de-identified by removing patient watermarks.