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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 (firstname.lastname@example.org) 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, Advarra doesn’t automatically add it for P-ICECAP. The first page of the consent PDF explains this. 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. However, typically if the site specific injury language is needed in addition to what is in the master consent - this will go in your site consent “black box.”
Q: The consent indicates there is no payment for participation however, I thought the family will receive $150 for travel to the follow-up appointment. Should this language be included in the consent?
A: Per SIREN policy, subjects are not paid for participation in the study. However, sites may elect to provide funds for travel expenses to return for the 1 year neurologic exam. The budget allocates $150 for this, but it is up to the site how much to provide to subjects. While the site payment lists $150 (remember to budget for this based on the indirect rate your institution subtracts!) for this in the payment schedule – a site can elect to reimburse MORE or LESS if they chose depending on the GSA per diem reimbursement for their area. For example … Wilmington DE – is $131. The SIREN reimbursement policy is here.
Q: Are we able to add the language to the consent regarding the "compensation/reimbursement" of $150 to cover the travel expenses of the families for the 12 month follow up Neuro visit?
A: Yes, the consent is general regarding payments because each site may be different. I am attaching the SIREN policy SOP SIREN SOP Participant Reimbursement that Advarra has seen, and you can add your reimbursement statement to the other additional language for the black box on the consent. ADVARRA and SIREN are both sensitive to the fact that the reimbursement for travel expenses is NOT compensation for study participation and that depending on how expensive a city is, the reimbursement available may be less than or greater than $150. If you really insist on putting site specific language in the black box consider non-specific language like “You may receive some reimbursement for travel expenses for the 1 year follow up.” If your IRB pushes back on this and says you should put a specific amount, you should refer them to the SIREN policy and note that the GSA per diem allotment is likely to change for each city over the course of this multi-year study.
Q: My IRB wants complete HIPAA information placed in the black box.
A: A full HIPAA authorization cannot be added to the black box. The HIPAA authorization is already embedded in the body of the consent. Have your IRB review the consent document for this language. Your IRB may ask for additional, site-specific, non-duplicable HIPAA language to be added in the black box area, if needed. Your IRB may, if unsatisfied with this policy, require a separate free-standing HIPAA authorization form with their own words. You will need to collect that form and retain locally in addition to having the P-iCECAP informed consent signed.
Q: Do you have a Spanish consent form?
A: ADVARRA uses a professional service to translate each site consent (with site specific language as applicable) into Spanish.
After your site cedes, and we submit to Advarra, when your site is approved by Advarra they give us both English and Spanish versions of your site specific consent form.
Q: Do you have a consenting script?
A: We do not have this as each situation will be unique and will be done under challenging circumstances requiring team member discretion. The “key information” at the top of the consent form provides a number of the key points.
Q: I got an email from Advarra instructing me to do something. What should I do?
A: You will occasionally receive emails from Advarra. Often, this is an automated email. The wording may instruct you to login and complete something. You DO NOT need to do this. As with all SIREN studies the CCC completes and submits the site application on your behalf.
Just remember, for PICECAP you will never need to login to Advarra.
Q: Where do I find the conflict of interest form?
A: There are questions for you to respond to in P-ICECAP> Central IRB>Initial Site Submission re: COI. See the Regulatory Parameters Document under “Getting Started” Getting Started | SIREN on the P-ICECAP webpage for more details and if additional documentation is necessary.
Q: Is the conflict of interest disclosure form 3455 or something else?
A: COI can be waived under the Site Reg Doc submission. Please see page 8 of the Regulatory Parameters document (in Getting Started). If there is a conflict, you will provide details in the Initial Site Submission form.
Form 3455 would be completed if there are COIs to report.
Q: For the daily CRF’s, when does day 1 start and day 2 start? Is it a calendar day? Or is it the first 24 hours after randomization that could span over two calendar days?
A: Day 1 is the day continuous temperature monitoring (and the definitive temperature control device) starts. (This could be prior to randomization).. Day one starts with the first hour of continuous temperature monitoring and goes to 23:59. The next day starts the next calendar day at 0000.
Q: Can you explain the difference between the daily AE CRF and Medwatch CRF?
A: This form applies only to select SAEs. The form is a conditional form and should only be completed if a MedWatch is required by the Independent Safety Monitoring review process. This will be RARE. (only when an SAE is serious, related and unexpected) This form is used to report these events to the FDA.
When it is required, the Medwatch form will appear in the applicable subject’s CRF binder. Study team members will be notified that it is required. Selected fields in the form will pre-populate with information derived from other CRFs. Fields that have not been pre-populated should be completed by the study team Please follow instructions for completing form FDA 3500A at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM295636.pdf.
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: Funds for electronic tablets 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: I know that Kennedy Krieger completes the VABS-3 at both 3-month and 12-month time points. Does she complete the PedsQL forms and CRFs associated with them too, or is that a site responsibility?
A: Kennedy Krieger completes all assessments for month 3 and month 12 - except of course the neurologic exam which happens at the sites.
Q: Can you explain HSP requirements?
A: The site document called HSP Requirements is your site’s policy document about what training is required at your site to conduct research (see page 7 Regulatory Parameters Document) It might be a long document but that’s ok, upload as a PDF.
Each team member will need a People document uploaded to document their own individual HSP training. This will most likely be some kind of certificate.
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. In some cases, your institution may set up a study specific agreement with ADVARRA.. Your request for ceding and your local IRB acknowledgment of ceding request get uploaded to WebDCU. This might be a PDF of an email from your IRB.
Q: Will we need a separate contract for data sharing?
A: No the trial subaward from Michigan covers data flow to from your site to the DCC (at MUSC) and no separate data use agreement is needed.
Q: Are there any NIH funding source documents for the grant that we can include for our IRB submission?
A: You can find the information about NIH funding in the subaward your contracts office should be processing. The notice of award for the overall trial is included with your subaward documentation. The current grant number is 1UG3HL159134-01
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: Hourly temperatures need to be recorded in WebDCUstarting when the device is turned on. The device needs to be on (but not necessarily set to a low temperature) prior to a patient being eligible for the study. This means you will need to record the temperature and settings (mode, for the blanketrol) that occurred prior to randomization. There is a form on the website in the tool box that can be left with the device so this can be logged by the bedside nurse. If the nurses routinely memorialize all of this in the medical record (which is ideal), then you can refer to that when recording the temperatures for the study.
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. You will need to keep contact information for the parents/guardians locally.
Q: Will you accept PDF files as regulatory documents?
A: Yes - PDFs are preferred.
Q: Is there is an excel format for the budget for this study?
A: There is no excel spreadsheet. Michigan has an active subcontract with each site. The startup and per patient payments are outlined there. You can internally budget at your site, based on your anticipated enrollments, but we at the CCC do not have a specific requirement regarding how much you might allocate to an investigator versus research coordinator
Q: Will the sponsor be submitting the P-ICECAP study to CMS for Medicare Coverage approval?
A: No. We are not seeking Medicare coverage approval from CMS for P-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. P-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: How does participant reimbursement work for travel to 1 year neurology appointment?
A: P-ICECAP suggests $150 (minus indirects) for participant reimbursement. The ADVARRA approved policy is tied to the GSA per-diem rate for a city. Sites can reimburse up to the GSA lodging allowance per their city/state. Sites can allocate less if they like, but not more. Per Diem Rates | GSA NOTE: Each site can allocate the total of all funds received for enrollment and outcomes as they see fit.
Q: If you were at the Investigator Meeting, will the protocol training be documented for me in webDCU? Is that the case for data training and reg doc training?
A: If you attended the IM we are waiving the protocol training in WebDCU for you, but you’ll still need to do the regulatory and data training and fill out and upload the certificate for those. There are links under the Training & Education tab.
Q: Is there a document for us to upload for the 'Attestation of Study Team Education and Training'?
A: There are two different types of training - protocol training for study team members and clinical site education and training.
Attestation of Clinical Team Education and Training is a site level document that will be signed by the PI and uploaded near the end of the readiness process. This means you have educated the clinical teams caring for cardiac arrest patients who are not study team members about the study. You need to attest to this before you enroll.
The protocol training attestation for those that attended the meeting (People document) will be uploaded for you by the CCC.
Other study team members that did not attend will complete the online protocol training and complete a certificate to be uploaded (by you).
Q: How long is the turn around for staff to receive their access for WebDCU? I submitted names last week and they have not received a link to give them access.
A: Only the PI, PSC, and other team members helping with the DOA or uploading regulatory documents will have early access to WebDCU. The rest of the team will have access closer to when the first site will be released to enroll subjects. The turnaround for PI and PSC should be relative quick.
Q: Is WebDCU HIPAA Compliant?
A: Yes it is.