Advarra / Consent





Advarra / Consent

Q: Has our site been submitted for this study? If not, should I/PI complete the Investigator Application on the CIRBI dashboard to join the study within their system?

A: It has not been submitted yet and the CCC will submit it for you. So there is nothing for you to do directly with Advarra. Parts of your application will be downloaded from the information you will provide in WebDCU (once it has been released) Remember the 3 CIRBI tables we talked about? Two under SIREN and one under P-ICECAP. That’s your next task!


Q: How do we apply for ceding? What about the consent and the black box?

A: Step 1. You submit consent AS IS to your IRB with protocol to request ceding. Step 2. After review, if your IRB wants additional site specific language that is non-duplicative with the main consent – they provide that verbiage to you (site) and then you provide it to us (picecap-contact@umich.edu) in a word document or via the appropriate section in webDCU. Step 3. We review for duplicative language, and work on collaboratively making it acceptable to all parties. Step 4. We submit your consent to ADVARRA on your behalf after your IRB cedes. Step 5. ADVARRA reviews, and creates a final approved version in English and Spanish. Step 6. We at the CCC create the eConsent link for you, that has your specific language added.


Q: Does Advarra add our site information to page one of the consent? I only have a PDF version and can’t add our information.

A: Advarra will add this information for each site.


Q: At our institution, we require HIPAA and Risk of Injury language be added to our consents for studies conducted here. Some of these studies use Advarra as a central IRB, and this language was added, will Advarra automatically add the HIPAA and Injury language to our consent for this study since it was added to consents for other studies?

A: No, unfortunately Advarra doesn’t automatically add it. Your request for changes must flow through the CCC. It sounds standard so it should not be a problem. You can send it to us now to look over and we can give you the go ahead. Once the database is ready, you will be adding it to SIREN>Central IRB>Site Overview table. It then will be part of your application to Advarra which we will submit for you. If your site specific HIPAA authorization is extensive in some cases, sites have elected to create a completely separate HIPAA form for your participants to sign. Neither ADVARRA, nor the sponsor needs to have copies of any separate HIPAA authorization form. Most sites DO NOT use a separate form, as they are able to use some combination of a couple of additional paragraphs and the nationwide, locked language.




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.


Q: Does the study supply an electronic device for doing e-consent?


A: Electronic tablets (funds for) will be supplied by the study for doing eConsent. Data is not stored on the tablet but is transferred to the UM REDCap when consent is saved. Moni will forward more information about tablets which can be purchased after Advarra approval. You will need to confirm you will have wireless internet access to use them.






Q: My site IRB uses Smart IRB for reliance agreements. How does that work?

A: Please contact your IRB for assistance with this. You can also reference instructions from Advarra: Using Smart IRB


Q: Will Advarra request a waiver of authorization for recruitment or do we need to do that locally?

A: When we submit to Advarra on your behalf we will request the waiver. You can note this in your ceding application if needed.


Q: Is there any reliance agreement my IRB will sign to document their reliance decision?

A: We do not have a specific document for you. Your site has either a SMART IRB agreement or a formal reliance agreement in place so the IRB will to sign that agreement and provide you with documentation in a letter or email. That is what will get uploaded to WebDCU. We will also need documentation of the request you made for ceding. An email is fine for that as well.




Q: Why is there an IDE for P-ICECAP even though the devices are FDA approved? 

A: Simply put, this is an investigator (who serves as FDA sponsor) initiated study using FDA cleared devices for temperature control off-label (for hypothermia) in a high risk population and is not intended to lead to a labeling change on any specific device. A longer explanation is that it is easy to misunderstand the purpose of P-ICECAP because of the IDE involved. The use of devices to control temperature is standard care in this trial, and temperature management 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 for a similar adult trial, 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 for adult ICECAP and the agency recommended we obtain a separate IDE for P-ICECAP because of the different population and different outcome measure. 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. Since the devices need to be in use prior being eligible for the trial, (and also for patients who are not in the trial) the study does not cover the cost of the devices.

Q: Do we have an FDA 1572 form associated with p-icecap?

A: No. It is a device study. Form 1572 governs drug/biologics. There will be an investigator agreement that the PI will need to sign.


Q: Is there separate temperature reporting required by the nursing staff outside of standard of care?

A: We require temps (once an hour) starting when the device is turned on. This means you will need to peek at the temperature and settings (mode, for the blanketrol) even before you consent. There is a form on the website in the tool box to do so.


Q: When it comes to the collection of identifiers I see in the CRF that we will be keeping dates, but what about MRN and names?

A: There is no PHI (other than date of birth) collected in the WebDCU database