Frequently Asked Questions
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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. You do not need to complete anything directly with Advarra. Parts of your application will be downloaded from the information you provide in WebDCU (once released). Remember the three CIRBI tables we discussed? Two are under SIREN, and one is under P-ICECAP—completing those is your next task!
Q: How do we apply for ceding? What about the consent and the black box?
A:
- Submit the consent as is to your IRB along with the protocol to request ceding.
- If your IRB requires additional non-duplicative site-specific language, provide the verbiage to the CCC (picecap-contact@umich.edu) in a Word document or via WebDCU.
- The CCC will review the requested changes for duplicative language and work with you to finalize them.
- Once your IRB cedes, the CCC will submit your consent to Advarra on your behalf.
- Advarra will review the consent and create a final approved version in English and Spanish.
- The CCC will generate an eConsent link for your site with the approved language.
Q: Does Advarra add our site information to page one of the consent?
A: Yes, Advarra will add this information for each site.
Q: Our institution requires HIPAA and Risk of Injury language in consents. Will Advarra automatically add this since it was included in previous studies?
A: No, Advarra does not automatically add this for P-ICECAP. Your request must go through the CCC. If your IRB requires this language, you can submit it to the CCC for review.
Q: The consent states there is no payment for participation, but families receive $150 for travel. Should this be included in the consent?
A: Subjects are not paid for participation, but sites may provide up to $150 for travel expenses for the 1-year neurological exam. The amount can vary by site based on the GSA per diem rate. If your site wants to include this, language like “You may receive some reimbursement for travel expenses for the 1-year follow-up” is preferred.
Q: Can we add language regarding the $150 travel reimbursement in the consent?
A: Yes. The consent is general regarding payments because each site may be different. If your IRB requires a specific amount, refer them to the SIREN reimbursement policy and GSA per diem rates.
Q: My IRB wants complete HIPAA information in the black box. Can this be added?
A: No, a full HIPAA authorization cannot be added to the black box because it is already embedded in the consent document. However, site-specific, non-duplicative HIPAA language may be added. If your IRB requires a separate HIPAA authorization form, it must be retained locally.
Q: Do you have a Spanish consent form?
A: Yes. After your site cedes, Advarra will provide approved English and Spanish versions of your consent form.
Q: Do you have a consenting script?
A: No, as each situation is unique. The “Key Information” section at the top of the consent form provides the most important points to cover.
Q: I received an email from Advarra instructing me to complete something. What should I do?
A: You do not need to take action. The CCC submits all site applications to Advarra on your behalf.
Q: Where do I find the conflict of interest form?
A: COI information is provided in P-ICECAP > Central IRB > Initial Site Submission in WebDCU. Additional details are in the Regulatory Parameters Document on the P-ICECAP webpage.
Q: Is the conflict of interest disclosure form FDA Form 3455?
A: COI disclosure may be waived under Site Reg Doc Submission. If a conflict exists, provide details in Initial Site Submission. Form 3455 is completed only if there is a COI to report.
Q: When does Day 1 start for daily CRFs? Is it a calendar day or based on the first 24 hours after randomization?
A: Day 1 starts when continuous temperature monitoring begins (which may be before randomization). It runs from the first recorded hour until 23:59 that day. The next day starts at 00:00.
Q: What is the difference between the daily AE CRF and MedWatch CRF?
A: The MedWatch CRF is used only for serious, related, and unexpected SAEs. When required, it appears in the subject’s WebDCU CRF binder, with selected fields pre-populated.
Q: Is the SIREN eConsent platform Part 11 compliant?
A: Yes, it is 21 CFR Part 11 compliant through the University of Michigan’s REDCap implementation.
Q: Does the study supply an electronic device for eConsent?
A: Yes, funds for electronic tablets will be provided. Tablets do not store data locally—all consent data is transferred to UM REDCap.
Q: Who completes the VABS-3 and PedsQL forms at 3-month and 12-month visits?
A: Kennedy Krieger completes all assessments except for the neurological exam, which is conducted at the site.
Q: Can you explain HSP requirements?
A:
- HSP Requirements document: A site-level policy document outlining training requirements for research.
- Individual HSP training certificates: Each team member must upload proof of completion.
Q: My IRB uses Smart IRB for reliance agreements. How does that work?
A: Contact your IRB or refer to Advarra’s Smart IRB instructions.
Q: Will Advarra request a waiver of authorization for recruitment?
A: Yes, this will be requested on your behalf when the CCC submits your site’s application.
Q: Why does P-ICECAP have an IDE if the devices are FDA-approved?
A: The study evaluates duration of hypothermia, not a device. Because FDA-regulated devices are used, an IDE was obtained for regulatory science purposes.
Q: Do we have an FDA 1572 form for P-ICECAP?
A: No. Form 1572 applies to drug/biologic trials. An Investigator Agreement will be signed instead.
Q: Will there be separate temperature reporting outside of standard care?
A: Yes. Hourly temperatures must be recorded in WebDCU starting when the device is turned on.
Q: Will regulatory documents be accepted in PDF format?
A: Yes, PDFs are preferred.
Q: Is WebDCU HIPAA-compliant?
A: Yes.
Q: How does participant reimbursement work for travel to the 1-year neurology appointment?
A: Sites may provide up to the GSA per diem rate for lodging/meals. P-ICECAP suggests $150, but sites may adjust based on location.
Q: If I attended the Investigator Meeting, will protocol training be documented in WebDCU?
A: Yes, but you must complete regulatory and data training separately.
Q: Is there an attestation document for study team training?
A: Yes. The Attestation of Clinical Team Education and Training is uploaded before enrollment begins.