HOBIT FAQs
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Q: Who is the IRB of record? What about other pertinent IRB information?
A:
- Name of the IRB of record: Advarra
- Contact person at the IRB of record: Sarah Weir
- IRB of record project number: Pro00024234
- IRB of record FWA number: FWA00023875
- IRB of record registration number: IRB00000971
Q: What is required to submit in WebDCU for the central IRB?
A: Sites must complete three tables in WebDCU:
Initial Site Submission Table: Go to [HOBIT] Icon in WebDCU → Click on [Central IRB] → Click on [Initial Site Submission] to complete.
Site Overview Table: Go to [SIREN] Icon in WebDCU → Click on [Central IRB] → Click on [Site Overview] to complete the table.
Site Regulatory Inspection History Table: Go to [SIREN] Icon in WebDCU → Click on [Central IRB] → Click on [Site Regulatory Inspection History]. Complete a new record for each regulatory inspection in the last five years. If there were no inspections, attest to that.
Q: How do I respond to a participant who says they want to withdraw from the study?
A: Participants always have the right to withdraw at any time. Study personnel should clarify whether they want to stop all participation or specific elements of the study. If they agree, you may continue monitoring their medical records. Otherwise, document their withdrawal and respect their wishes.
Q: Do subjects need to be consented when they regain the capacity to consent?
A: No. Enrollment is based on consent from a legally authorized representative (LAR). However, participants may withdraw from the study at any time.
Q: The timestamp on the e-consent does not reflect my time zone. What should I do?
A: A generic note to file is available to clarify the time zone discrepancy in the e-consent PDF.
Q: What happens to the equipment that has been installed by Bill Gossett at the monoplace sites after the trial is over? Do the sites keep this?
A: The equipment remains the property of the Federal Government throughout the trial. After the trial, ownership will normally be transferred to the hospital.
Q: Where do I find my site’s FWA number?
A: You can pull your site’s FWA number from the OHRP website: https://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc.
Q: Is the SIREN e-consent platform Part 11 compliant?
A: Yes. The University of Michigan’s REDCap implementation is 21 CFR Part 11 compliant. Supporting documentation is available through SIREN.
Q: If a subject has both Pulmonary Dysfunction (PaO2/FiO2 ≤ 200 or requiring PEEP > 10cm H₂O) and pneumonia (or ARDS), should these events be reported as separate SAEs?
A: No, related conditions should be grouped under a single SAE diagnosis (e.g., pneumonia or ARDS). Pulmonary dysfunction alone should be reported separately only if no related diagnosis is present.
Q: When should critical hypotension or a critical decrease in cerebral perfusion pressure (CPP) be recorded as an SAE?
A:
- Critical hypotension: MAP <70 mmHg on at least two consecutive measurements 30 minutes apart.
- Critical decrease in CPP: CPP <60 mmHg on two consecutive measurements 30 minutes apart.
- During the first 5 days, all occurrences should be grouped into one SAE entry.
Q: If an AE occurs after Day 6 but before hospital discharge, which day should it be recorded under?
A: Enter it under Day 6. It will be analyzed based on the date of onset.
Q: Should death be considered an SAE?
A: No. Death is considered an outcome. The event causing death should be reported as the SAE.
Q: How do you identify subjects with a Marshall Head CT score >1?
A: Any subject with evidence of traumatic intracranial abnormality on head CT has a Marshall Head CT score >1.
Q: When should GCS be obtained?
A: After resuscitation, once the patient is medically stable and off sedatives and paralytics.
Q: Which GCS should be used to determine eligibility for HOBIT?
A: The most reliable GCS obtained after resuscitation and off sedatives/paralytics, closest to enrollment.
Q: If a subject has a pneumothorax, should they be excluded from HOBIT?
A: No, as long as they have a chest tube in place. However, patients with a PaO2/FiO2 (PF) ratio <200 despite PEEP of 10 cm H₂O should be excluded.
Q: What should I do if a subject is randomized but unable to receive the initial treatment within the prescribed time window?
A: They remain in the trial. Report this as a protocol deviation in WebDCU, but they may still receive subsequent HBO treatments.
Q: Should intracranial monitors (ICP and PbtO2) be left in place for all 5 days of HBO treatment?
A: No, they should only remain as long as clinically necessary.
Q: If a subject starts following commands, should HBO treatments continue?
A: No, treatment should be stopped. However, before stopping, call the PI hotline (833-HOBIT-PI).
Q: Are there plans for site monitoring?
A: Yes. On-site monitoring will occur after the enrollment of the first subject at each site, with additional monitoring as needed.
Q: How do I add a new team member to the database?
A:
- Click on [Study Team Member Request] under [User Management] in WebDCU.
- Click [Add New] and complete fields 1-8.
- Save the record.
Q: How do I remove a team member’s permissions from WebDCU?
A:
- Click on [User Management] → [User Permission Request].
- Select the person’s name and click [Edit Record].
- Remove all user group permissions under Question 5.
- Save the record.
Q: How should screened patients be entered into the WebDCU Screening Log during the COVID-19 enrollment hold?
A: Screen as usual and indicate the reason for ineligibility. If the patient is otherwise eligible, select “other reason” and enter “COVID-19 hold.”
Q: Should sites bill for HBO treatments done as part of the study?
A: No. HBO treatments are performed for research and should not be billed to insurance. The study provides payments of $1,000 per dive. However, non-HBO treatments given as part of standard TBI management may be billed.