Q: Who is the IRB of record? What about other pertinent IRB information?
A: See below
- Name of the IRB of record: Advarra
- Name of the 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 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.
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.
Q: Where do I find my site’s FWA number?
A: You will need to pull your site’s FWA number from the OHRP website: https://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc.
Q: Who can administer the GOSE exam?
A: We are looking for a neuropsychologist, physician or nurse. This person must be blinded to study treatment.
Q: Can we film the simulation in segments?
A: Yes, sites can divide the simulation video into segments. It does not necessarily have to be done all at once. Sites could do the HBO separate from the ICU, and so forth.
Q: Who should be involved in the simulation?
A: We recommend that the following study personnel should be present for the simulation: the study PI, a study coordinator, ICU physician responsible for caring for TBI patient, a HBO tech, an HBO physician investigator, a respiratory therapist (if that is different from the HBO tech), and an ICU nurse.
Q: How should we film the simulation?
A: We recommend using a smart phone or video camera.
Q: How do I add a NEW team member to the database?
A: All study team members will need to be added to the HOBIT database and then added eDOA.
- Click on [Study Team Member Request] under the [User Management] tab
- On the right hand top corner of screen, click on [Add New]
- This opens a new Study Team Member Request record – complete fields 1 through 8 and Save record.
Q: How do I set up a team member’s user permissions to access WebDCU (eg. Study Coordinator)?
A: To request user permissions in WebDCU, please go to HOBIT >> [User Management] >> [User Permission Request]. In that table you’ll see a list of all your site personnel. Click on the blue number next to the name of the person you wish to request permissions for, then click “Edit Record.” You can then add rows to request their permissions. Please note that “WebDCU User” is required for all users. Once permissions have been requested and the DOA log submitted and approved, SDMC will approve the permissions and they will receive an email with account login and password.
NOTE: Study team members will need to have an account set up using the [Study Team Member Request] table before user permissions can be requested.
Q: How do I modify a team member’s role and/or responsibilities?
A: First, add an end date for the team member’s whose role and/or responsibilities are being modified; then, add a new entry for the same team member with updated details for role/responsibilities and submit the eDOA for CCC review and approval. Discuss with site manager if the 1572 (and/or IRB Application) needs to be updated as well.
Q: I have a new team member on my study team. What are the steps to upload regulatory document for this new team member?
A: Follow the steps below:
- Add the new team member to the Database using the Study Team Member Request entry (See FAQs on adding a new study team member to database)
- Then add the team member to the eDOA log with start date, study role, and responsibilities.
- Submit eDOA log for CCC review and approval.
- After eDOA is approved by CCC, upload regulatory documents for new team member.
- Discuss with site manager and update 1572 if needed; upload updated 1572.
NOTE: It is the site’s responsibility to ensure that all new team members are added to the IRB application and approval is obtained before the study team member performs study related tasks.
Q: How can I submit site (or people) regulatory documents?
A: Follow the steps below.
- From the main menu page, click on [Regulatory Document] and then [Site (or People) Reg Doc Submission] table.
- To upload a new document, click on the Green Arrow for the document that you want to upload
- If there are any existing documents available for selection, they will be listed.
- If there are no existing document available, or none that you would like to select, click on the ‘upload new file’ link, browse for the document, and then click upload.
- Enter the required information, and then click ‘Save Record.’
Tip: User Management Site Reg Doc Status table: This will display a table view of the documents required at your site as well as the submission status of each document.
Q: I have a 1572 completed for my site. Do I need a Delegation of Authority (DOA) log as well? What is eDoA?
A: All sites need a DOA log and completed 1572. For HOBIT, in WebDCU, the DOA is entered electronically and is called eDOA. Upload the completed and signed 1572 for your site as “FDA Form 1572 – Statement of Investigator.”
Q: Where can I find the electronic Delegation of Authority (eDOA) log and how do I complete the entry?
- Login into WebDCU-HOBIT,
- Click on the [User Management] tab
- Click on [DOA submission]
- Click on the blue # (number) link to the left to edit the eDOA
- Lastly, click [Edit Record] on the top right hand corner of the page.
- Add the team members to the eDOA list (They need be added to the study team member request table first, see Q on “How to add NEW team member to the database?”)
- Add responsibilities for each team member.
- Click [Submit] for the entry to be sent to the site manager for review and approval.
Q: How do I remove a team member's permissions from WebDCU?
A: A team member’s user account access is NOT updated once an end date is added to the eDOA log. User permissions also need to be updated.
Remove all user groups in the [user permission request] table for the departed team member. Please refer to the steps below.
- Click on the [User Management] tab, and then [User Permission Request] .
- On the list record page, click on the blue number link to the left of the study team member name you are looking for.
- Click on [Edit Record] in the top right hand corner of the screen. Remove all user group permissions in Question 5. When done, click [Save Record].
- SDMC Data manager will review and approve the request.
Q: How can a team member stop receiving WebDCU’s automated regulatory document emails?
A: Follow the steps below.
- Contact the coordinator in charge of adding people/submitting reg docs (usually the primary study coordinator) and request that your permissions be updated.
- Coordinator in charge, click on [user permission request] tab.
- Click edit record, and remove the user group [Submit Regulatory Document].
- Data manager at SDMC will approve the entry.