Q: Do I submit my site’s application to Advarra?
A: No. Sites do NOT submit applications directly to Advarra. The Siren CCC will submit site applications to Advarra once the site has completed the “Initial Site Submission” in WebDCU under ICECAP – Central IRB. Sites should be submitting requests to their local IRBs to cede to Advarra. The ceding request to the local IRB and the ceding acknowledgement from the local IRB both need to be uploaded and accepted to WebDCU prior to site applications being submitted. Sites should also be working on uploading e-DOAs and other regulatory documents into WebDCU.
Q: What is required to submit in WebDCU for the central IRB? (NEW 3-31-20)
A: Sites must complete 3 tables in WebDCU.
- Start with the Site Overview table. Go to [SIREN] Icon in WebDCU – click on [Central IRB] – click on [Site Overview] to complete the table.
- (If the table is already completed for your site, please review and email the site manager to verify that it correct).
- Next, complete the Site Regulatory Inspection History table as needed; go to the [SIREN] icon in WebDCU – click on [Central IRB] – click on [Site Regulatory Inspection History].
- You must complete a new record for each regulatory inspection for the Investigator or your research location(s) that have occurred in the last 5 years. If there are no inspections, you will need to attest that the site nor the investigator has had any reportable audits in the past 5 years.
- Lastly, complete the Initial Site Submission table; go to the [HOBIT] icon in WebDCU – click on [Central IRB] – click on [Initial Site Submission] to complete.
- Please ensure that you have uploaded ALL of the regulatory and people documents to WebDCU BEFORE completing this table.
Q: Why did you get an IDE if you are not testing the safety and efficacy of an investigational device?
A: It is easy to misunderstand the purpose of ICECAP because of the IDE involved. The use of hypothermia is standard care in this trial, and neither the induction of hypothermia nor the devices used are the intervention being tested. Indeed induction of hypothermia with a definitive temperature control device has to have already occurred as part of standard care before a patient can even be enrolled in this trial. The intervention in the trial is only duration of hypothermia. We worked with FDA to determine whether or not to do an IDE, since the trial tests duration but does not test a device, and does not specify a device to be used. Because FDA regulated devices are used, and FDA is interested in using the trial for purposes of regulatory science, we collaboratively decided to get the IDE. Application of the devices is not experimental. The devices are investigational in the trial, but only in regard to being used for varying durations of cooling.
Q: Will the sponsor be submitting the ICECAP study to CMS for Medicare Coverage approval?
A: No. We are not seeking Medicare coverage approval from CMS for ICECAP because there are no protocol required billable devices or services to ask CMS to cover. There is an IDE because FDA regulated devices are being used, but the trial is not designed to test the efficacy or safety of an investigational device. The trial tests the effect of duration on outcome regardless of the device used.
- The cost of the devices is not a covered research expense because induction of hypothermia with a definitive temperature control device has to have already occurred as part of standard care before a patient can even be enrolled in this trial. CMS research coverage approval is only applicable to cost incurring after and because of enrollment in the trial. It does not apply to cost incurred prior to a trial. Duration of use is not a billable device cost, and does not involve a coverage request.
- Also, there are no routine care costs attributable to participation in the trial for which CMS coverage is requested related to this IDE study. ICECAP’s billing calendar is simple at all sites. The protocol only calls for the collection of labs, imaging, and testing that have been done for clinical purposes. No labs, imaging, or testing are required or performed for research purposes.
In summary, the devices are being used inside and outside the study and no study procedures are billed to clinical insurance.
Q: Is the SIREN e.consent platform part 11 compliant?
A: Yes. SIREN uses the University of Michigan implementation of the REDCap platform to obtain electronic consent and (in some SIREN studies) participant contact information in a process that is 21 CFR Part 11 compliant. Part 11 compliance requires information technology that is capable of supporting compliant processes, and specific operating procedures that use the IT appropriately. Documentation from the University of Michigan Health Information Technology and Services (HITS) of the physical and network information technology security that supports Part 11 compliance in this implementation is available here. Documentation that the SIREN processes are Part 11 compliant is found in the SIREN Network e.consent SOP.