Introduction to webIRB Training Course for Investigators and Study - - PowerPoint PPT Presentation
Introduction to webIRB Training Course for Investigators and Study Staff V: 01.24.13 0 You will learn to 1. Navigate webIRB 2. Create a new Study application 3. Respond to IRB Requests 4. Create an Amendment application 5. Create a
V: 01.24.13
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W hen using I nternet Explorer:
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W hen using Mozilla Firefox, follow these steps to access the Sandbox:
see “Add Exception..”
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pop-up window click on “Confirm Security Exception”
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Navigation Bar
My Hom e - find your way home Your Nam e- Update your contact information
Breadcrum b - Find your way through the study workspaces
My I RB Studies – contains all
have been withdrawn, closed, and don’t require UCLA IRB review. My I nbox - contains links to submissions that need your attention: NS = New Study PAR = Post-Approval Reports & Single Subject Exception AM = Amendment CR = Continuing Review or Closure
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Click to create a New Study
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For help with answering a question, click on
in grey text box.
The General I nform ation Section of the Study Smartform will appear. Provide a response to each question. The questions with a red asterisk (* ) are required.
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Click Save after completing the General Information section.
purposes.
Item 3.1 (PI); Item 4.0 (Study Contact); or Item 5.0 (Key Personnel) After clicking Save more activities will appear at the top of the page.
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Activities that will appear in the menu bar after clicking Save. I m portant Note:
have an auto-save feature.
periodically to ensure that your work is saved.
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The Jum p to Menu can be used to go to specific sections of the application.
that will be required Note: More sections may be added as you answer items in the form
Use Exit to go to the Study workspace. Use Continue to navigate forward through the form
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Current State Study Activities Summary information about the Study Information Tabs Views of the Study
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Common “Current State” for All Project Types Current State What the “Current State” Means Pre-Submission Project has not been submitted. In-Review Project or response has been submitted. The IRB is reviewing the project or response.
Additional information is required to review and approve the project. Assigned to IRB Meeting The project will be reviewed at the next Full Board meeting.
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PI Study Staff PI Proxy Faculty Sponsor
Available activities differ by the current state of the protocol and role of the person.
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Sponsor (FS) for the study, his/ her assurances are required before the study can be submitted.
Notification to FS for FS Assurances to send a message to your FS.
Faculty Sponsor. The email will provide a link to the study workspace.
to the PI.
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Click on the activity Subm it Study when the application is complete. This activity is available to the PI, PI Proxies & FS. Send Ready Notification is available to all other Study Staff. An email will be sent to the PI, PI Proxies & FS that contains a link to the study workspace.
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If the application is complete, you will get a Subm it Study screen. Click OK to submit.
you will get an Error/ W arning Message.
with the incomplete item(s).
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submitted the PI Assurances activity becomes available.
be completed by the PI (and only the PI) before the study can be approved. The study team can check to see if the assurances are completed on the summary screen
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Training Rem inder activity to remind your staff to complete their training.
should receive a training reminder email (see next slide).
available to the PI, PI Proxies, FS & Contact Person.
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Click the Training Log tab to see your study team member’s training certificate.
research team can upload his/ her training certificates in their webIRB profile.
certificates will appear in the Training Log tab.
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W ithdraw activity if you are no longer planning to conduct the study.
archived.
to everyone.
be reactivated using the activity Reactivate. The Reactivate activity is
the PI, PI Proxies & FS.
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Only the PI can add a PI Proxy using the activity Edit PI Proxy.
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the Study workspace use the activity Study Team – Log Private Com m ent.
study team member who should receive your message.
to the study team member with a link to the study workspace.
available to all study team members only.
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Click Edit Study to go back to the Smartform
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pages needing completion. Click the links to go to the pages.
providing your response(s).
completing by clicking Refresh. The error screen will update. Click Hide/ Show Errors again to hide the screen
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Click Exit to go back to the Study Workspace Click My Hom e to return to your webIRB homepage
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Click on the Study in your Inbox titled “Test Study for w ebI RB Training – Basic ….”
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I RB Requests are:
I RB Requests can be view ed in
Amendment”
Modified Study”
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FS & Contact Person will receive an email notification when the IRB: requests pre- review changes issues a letter (i.e., IRB Determination)
email to go to the project workspace and respond to the IRB requests.
the em ail.
DATE: Today’s date and time
TO: Name of PI FROM: Name of IRB Staff RE: Request for Additional Information LINK: IRB# 12-00111 Title of Study Additional information and/ or changes are needed to complete the submission for the above-referenced study. A detailed list is provided under the IRB Requests tab in the study
I m portant Note: Click here for instructions on How To Respond to I RB Requests. Please remember to click Subm it Response activity when you have completed the requested changes. This will send the study back to the IRB for further review. CC: Name of PI Proxy Name of Faculty Sponsor Name of Study Contact
Example of webIRB email notification the PI will receive when the IRB Requests Pre-Review changes to his/ her study application.
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the email notification will say “The IRB has made a determination… ” The email does not state whether the letter is an approval/ certification of exemption or contains IRB requests.
to the workspace to view the letter and if necessary respond to the IRB requests.
DATE: Today’s date and time
TO: Name of PI FROM: Name of IRB Staff RE: IRB Determination LINK: IRB# 11-001111-CR-00001 Title of Study The IRB has made a determination regarding the continuing review for the above- referenced study. For details, please click on the above link to go to the CR workspace. CC: Name of PI Proxy Name of Faculty Sponsor Name of Study Contact
Example of webIRB email notification the PI will receive when the IRB issues a letter for the CR.
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To contact or reply to MRSC, please use the “Send Inquiry or Reply to MRSC” activity. Note: Using the “Send Inquiry or Reply to IRB” will NOT reach the MRSC administrator.
If your project involves Radiation, the Medical Radiation Safety Committee will also communicate with you using webIRB
inquiry or reply, the notification will say “Correspondence from the RADIATION SAFETY”
to the workspace to view the inquiry/ reply and if necessary respond to the MRSC requests.
Example of webIRB email notification the PI will receive when the MRSC administrator sends an inquiry or reply.
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for a Study click “Edit Study” or for an AM click “View Modified Study”
will appear.
1.1, click the arrow so that it points down .
1.1 you will see the message “There are no items to display”. Click on “Next” to view the next Section with an IRB request.
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DO NOT click “Click here to respond… ” yet, instead:
to respond… A dialogue box will open.
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When the dialogue box opens:
indicate how you are responding.
the Text box (e.g., Done, Complete). You do not need to repeat the response provided in the Smartform.
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Your response will appear in a green text box.
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BEFORE RESPONSE AFTER RESPONSE When the response has been completed, the color of the notes will change from red to green. To return to the Study Workspace, Click Save, then Exit. When there is more than 1 request, click Next to complete additional requests.
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Click Exit to go back to the Study Workspace Click Hide/ Show Errors to view any incomplete Sections
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requests have been completed/ addressed, your response will appear in a green text box in the I RB Requests tab.
must be completed/ addressed before the response can be submitted.
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PI , PI Proxy, FS: Click Subm it Response to submit the revised application to the IRB for review Study Staff: Use the Send Ready Notification to let the PI know that the response is ready to be submitted.
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Click here for a printable summary of the IRB Requests and your responses.
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The IRB Staff working on your study is listed here.
I nquiry or Reply to I RB activity to communicate with IRB staff.
notification will be sent to the IRB Staff (Owner).
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Click on My Hom e Click on the My I RB Studies tab. Click on the link to “Sam ple Approved Study for w ebI RB Training …”. Project State should be “Approved”.
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Unique features:
subm it, post approval applications (i.e., AM, CR, and PAR).
workspaces are accessible.
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letter only.
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approved documents
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the approved application 5 0
Each type of application has its own workspace after it is created.
PAR Workspace CR workspace – At continuing review the FS and PI Assurances must be completed in the CR workspace. Amendment Workspace
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Click on the Approved Docum ents tab to see all currently approved documents
documents approved for the Study
the AM go to the AM workspace.
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Links to consent forms and documents that were uploaded to the application. I m portant Note: Don’t add footers to documents that will be stamped by webIRB
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click on New Am endm ent.
appear.
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Complete the Description of Amendment section.
The title will appear on the AN.
there is change in study staff and/or key personnel New study staff/personnel will have access to the study when the AM is approved.
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justification for the changes you selected in Items 2.0, 4.0, and 5.0.
procedures for re-consenting subjects. 7.1- If applicable, attach the summary of changes provided by the sponsor.
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Addendum Consent Templates are available at http: / / ohrpp.research.ucla.edu/ pages/ biomedical-informed-consent
9.0- Indicate whether you are submitting a Post-Approval Report (PAR) with the Amendment.
PAR questions.
a separate application, select “No”.
Click Save when you complete this section. Click Continue to go to the next section
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Update the relevant sections of the currently approved protocol.
Continue button to navigate through the application.
revising each SmartForm page.
see sections that need completion.
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the marked and clean copy. Include the version
asssent_clean_010111”).
application.
document you want to remove.
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When you upload a revised document
Docum ent screen will open. 1. Click Brow se to select and upload document from your computer. 2. Then click OK.
Note: You can leave the Title field blank. The name of your document will be used.
When you upload a revised document, webIRB will update the version number on the screen.
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Study SmartForms.
Amendment Smartform. Click Finish. You will go to the Amendment workspace.
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Remember to click Subm it Am endm ent Information Tab
Reminder:
Am endm ent activity is available only to the PI and PI Proxy.
use the Send Ready Notification to let the PI/ PI Proxy know the Amendment is ready to be submitted.
Breadcrumbs
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Unique features:
and AM Approval letter (includes approved documents)
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and Modified Study application Note: A snapshot of Modified Study application will also appear in the History tab of the Study workspace.
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click on Continuing Review or Closure (CR).
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navigate through the sections.
providing a response to all the questions in each section.
Hide/Show Errors to see sections that need completion
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Continuing Review or Closure Report click Finish to go to the CR workspace
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If you have a Faculty Sponsor, use “Send Notification to FS for FS Assurances” to request his/ her assurances. Error!! If you have a Faculty Sponsor his/ her assurances are required before submitting the CR.
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The Faculty Sponsor must provide the appropriate FS Assurances in the CR workspace.
Continuing Review Assurances. Study Closure Assurances. Click ok
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Click “Submit Continuing Review” (or “Send Ready Notification”)
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The CR m ust be subm itted from its respective w orkspace.
CR workspace Rem inder: The Submit activity is only available to the PI, FS, and PI Proxy.
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Continuing Review Assurances: # 1-# 3 Study Closure Assurance
The activity PI Assurances will become available for the PI in the CR workspace after submitting the CR.
assurances by clicking on the activity in the CR workspace.
Assurances.
Click ok
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If you are submitting a PAR at the time of continuing review:
workspace to create the PAR.
submitted at the same times
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Click Login
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1. Enter your UCLA Logon ID and Password 2. Click Sign I n
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information in the Properties tab. Provide or update your:
done, click Apply.
Hom e to return to your homepage.
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Profile tab.
with your name to go to your Profile. Your Profile records information that will be central to all of your IRB submissions.
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Researcher Profile.
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and then click Continue.
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the UCLA Employee Database
available to the IRB for all of your future applications.
in Item 6.0.
training certification in Item 7.0.
the next section
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specific study personnel to automatically populate your webIRB applications, they can be added on this page.
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