eIRB 101: Prepare and Submit an eIRB Application

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eIRB 101 Prepare and Submitan eIRB Application

• Stephanie Gaudreau
• Joyce Lederman
• jhmeirb_at_jhmi.edu

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Computer Lab Login
320 SON Computer Lab Johns Hopkins Medical Campus
B 402 IS Computer Lab Bayview Medical Campus

• Login ID student
• Password student09
• Log onto Nursing

• Username
• Password TrainUser
• Log onto

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eIRB Home Page - http//irb.jhmi.edu/eIRB
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Topics

• Accounts and Websites
• Investigator Home Screen
• Application Workspace
• Application Screens
• Study Proposal
• Consent Form
• Application Complete
• Respond to IRB Issues
• Create a Further Study Action

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eIRB Accounts

• All users of eIRB must be assigned an account.
• To set up an account in eIRB, select JHED User
  Self Registration or Non JHED User Self
  Registration from the eIRB Login screen at
  http//e-irb.jhmi.edu.

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IRB Website - http//irb.jhmi.edu IRB
Guidelines, Regulations, General Information
Compliance Training Requirements
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Compliance Training Requirements
For assistance navigating compliance training
websites and obtaining electronic copies of your
certificates, contact the Institute for Clinical
and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/.
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Compliance Training Websites

• Human Subjects Research (HSR), Conflict of
  Interest (COI), and General Privacy Issues (GPI)
  are available online at the Compliance Training
  website http//secure.lwservers.net/.
• Be sure to save and print your certificates at
  the time you complete each course.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
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Compliance Training Websites

• HIPAA Research, CRBO, and CRMS courses are
  available online at Johns Hopkins Medicine
  Interactive http//www.Hopkinsinteractive.org .
• GPI is a pre-requisite for HIPAA Research.
• Be sure to save and print your certificates at
  the time you complete each course.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
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Compliance Training Websites

• Information about CORE is available online at
  Continuing Medical Education http//www.hopkinscme
  .net/CORE.html.
• Be sure to save and print your certificates at
  the time you complete each course.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
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IRB Website - http//irb.jhmi.edu IRB
Guidelines, Regulations, General Information
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eIRB Home Page - http//irb.jhmi.edu/eIRBeIRB
Information and Login Link
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eIRB Home Page - http//irb.jhmi.edu/eIRBeIRB
Help Guide - Instructions
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eIRB Home Page - http//irb.jhmi.edu/eIRBeIRB
Wizards
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Link to eIRB Login
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eIRB http//e-irb.jhmi.eduLogin with JHED ID
and Password
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eIRB http//e-irb.jhmi.eduLogin with JHED ID
and Password
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eIRB http//e-irb.jhmi.eduLogin with JHED ID
and Password
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Investigator Home Page
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Investigator Home Page
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Investigator Home Page

• Blue Title Bar
• My Home returns you to this screen.
• Black Tool Bar
• eIRB Helpdesk
• Step by step instructions and tutorials
• Contact information
• eIRB Survey
• Submits your feedback to the IRB.
• Blue Breadcrumb Trail
• Tells where you are in eIRB.

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Investigator Home Page

• Left Navigation Bar
• My IRB Studies lists all of your studies.
• eIRB Training lists all eIRB training classes
  open for registration.
• OPC Disclosures connects you to the Office of
  Policy Coordination screens.
• Create a New Application button.

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Investigator Home Page

• Investigator Tabs
• Action Required your previously submitted
  studies awaiting PI action.
• Researcher Prep your studies that have never
  been submitted.
• In Process your studies awaiting Pre-IRB or IRB
  action.
• Approved your approved studies.
• All My IRB Studies all your studies in
  preparation, in process, approved, disapproved,
  expired, terminated, or withdrawn.

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Investigator Home Page

• Studies List
• Your studies are listed by type.
• New Application
• Change in Research
• Continuing Review
• Protocol Event
• Termination Report
• Emergency Use
• Click the study name to open the study workspace.

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Application Workspace
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Application Workspace

• Application Waiting to be Submitted
• Disappears upon submission of the application by
  the PI.
• Study Vital Statistics
• Displays the study title, number, PI, IRB
  Committee, review type, last scheduled review,
  expiration date, and original approval date.
• Application Current Status
• Displays the applications current state in the
  submission/review process.

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Application Workspace

• Review List
• Displays the meeting date, review date, review
  type, meeting outcome, letter, and response.
• Workspace Tabs
• Provide quick access to study-related
  information.
• Will appear as needed.
• History Log
• Reflects completed activities.

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Application Workspace

• Left Navigation Bar
• Divided into three sections.
• View/Print New Application
• View/Edit Application gives access to the
  existing application.
• Printer Friendly View displays a scrollable
  version of the application with the option to
  print.
• Uploaded documents may be opened and printed
  separately from this view.
• View Differences lists changes made to the
  application since the previous submission.

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Application Workspace

• Left Navigation Bar
• Divided into three sections.
• View/Print New Application
• Progress Application Screens
• View Data Entry Progress
• Displays a list of application screens showing
  which are complete, incomplete, or not required.
• Current Activities
• Displays a list of activities that may be
  completed.

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Application Screens
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Application Screen

• This is the first screen of the application.
• It is what you see when you click the Create an
  Application button on the Investigator Home Page.

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Application Screen

• Blue Title Bar
• Application number is on the right.
• Light Blue Tool Bar
• Continue
• Saves your work and moves you through the
  application one screen at a time.
• Back
• Does not save. It takes you to the previous
  screen.
• Save
• Saves your work in progress.
• Exit
• Does not save. It returns you to the Application
  Workspace.
• Print
• Allows you to print the current section of the
  application.

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Hide/Show Errors

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Back
• Save
• Exit
• Print
• Hide/Show Errors
• Click to split the screen, display errors, and
  provide links to screens.
• Click again to hide the split screen.

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Jump To Drop Menu

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Back
• Save
• Exit
• Print
• Hide/Show Errors
• Displays errors and provides links to screens.
• Jump To
• Displays list of screens used.
• Use the list to navigate to non-consecutive
  screens.

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Required Field

• Required
• The red asterisk indicates a required field
  that MUST be completed.
• The PI will not be able to submit the application
  until all required fields have been completed.
• Be sure to enter a title for the study. Never
  leave the title field blank. You need a title to
  access the application.

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Assign Application Number

• Complete all required fields on the initial
  screen.
• Be sure to enter a title for the study.
• Click Continue to advance to the next screen.
• eIRB will create the application and assign a
  number to it before advancing to the next screen.
• eIRB application numbers begin with NA and may
  be found in the upper right corner of the
  application screens.
• Save will not work until the application number
  is assigned by eIRB.

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Help Tools

• Help Tools appear beside each question.

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Help Tools

• Help Tools appear beside each question.
• Regulatory Guidelines
• Click the ? icon to access IRB Regulatory
  Guidelines and Policies.
• Download Forms.
• Information Technology
• Click the i icon to access step by step
  technologic instructions.

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Select PI and Study Team

• eIRB considers the PI and the study team as two
  separate roles.
• The PI and study team are listed in two separate
  questions in the eIRB application.
• The list of study team members should never
  include the PI.
• The PI does not complete the Agree to Participate
  activity.
• Submitting the application is the PIs agreement
  to participate.

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Select Principal Investigator

• Click the Information Technology icon
  for step by step directions.

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Select Principal Investigator

• Click the Information Technology icon
  for step by step directions.

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Select Principal Investigator

• Click the Information Technology icon
  for step by step directions.

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Select Study Team Member

• Click the Information Technology icon
  for step by step directions.

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Select Study Team Member

• Click the Information Technology icon
  for step by step directions.

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Select Study Team Member

• Click the Information Technology icon
  for step by step directions.

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Study Team Compliance Training

• Verify compliance training information on the
  eIRB application screen 2 Study Team
  Compliance Training question 1.0.
• It is not necessary to send compliance training
  certificates in advance of an eIRB submission.
• If compliance training dates are incorrect or
  missing, upload copies of training certificates
  into question 2.0 and we will enter the dates
  into the eIRB system upon submission of the
  application.

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Study Team Compliance Training

• Study team members not affiliated with Hopkins
  are also required to upload a copy of their human
  subjects research compliance training
  certification.
• Research compliance training certification from
  the local institution, Collaborative
  Institutional Training Initiative (CITI), or
  another institution such as the National
  Institutes of Health (NIH) will be accepted.  

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Study Team Compliance Training

• Be sure to save and print your certificates at
  the time you complete each course.
• Electronic copies of certificates are necessary
  for uploading.
• For assistance with the compliance training
  websites contact the Institute for Clinical and
  Translational Research (ICTR)http//ictr.johnshop
  kins.edu/connection/.
• The IRB does not monitor, maintain, or have
  access to the compliance training websites.

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Support InformationMonetary and Material

• Funding or material source not listed?
• Email jhmeirb_at_jhmi.edu with the name of the
  funding or material source and we will add it to
  eIRB.

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Add/Edit Documents

• Many documents or forms will be uploaded into
  eIRB.
• Click the Information Technology icon for
  step by step directions.

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Add/Edit Documents

• Many documents or forms will be uploaded into
  eIRB.
• Click the Information Technology icon for
  step by step directions.

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Documents and Forms

• Only electronic documents/forms are accepted in
  eIRB.
• Forms must be downloaded from within the
  application.
• Paper copies of documents/forms must be scanned
  and converted into electronic copies.
• The Office of Human Subjects Research (OHSR) has
  a high-speed scanner that may be used to convert
  paper documents into Adobe Acrobat (.pdf) files.
  Call 410-955-3008 or send an email to
  jhmirb_at_jhmi.edu to schedule an appointment.
• Some Macintosh users need to add the three
  character PC style file-type extensions to Mac
  file names before uploading into eIRB.

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Drill Down

• Drill down screens look like a document upload
  field.
• Click Add to open screens requiring additional
  information.
• Answer the questions.
• Click OK.
• Save the screen.
• Click Edit to open the existing screens to
  upload documents, add, or revise information.
• Click OK and save the screen.

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Study Proposal
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Download eForm A

• Click the icon.

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Download eForm A

• Right click the link to eForm A.
• Save the form to your local drive.
• Use a simple name including the upload date.
• eFormA_102008.doc
• Complete eForm A and save it to your local drive.

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Upload Protocol

• The protocol field is a single upload field.
• It does not display the colored bars that
  indicate a multiple upload field.
• Click the Information Technology icon for
  step by step directions.

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Upload Protocol

• The protocol field is a single upload field.
• It does not display the colored bars that
  indicate a multiple upload field.
• Click the Information Technology icon for
  step by step directions.

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Upload Protocol

• Click Add to upload the completed eForm A.

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Upload Protocol

• Click Add to upload the completed eForm A.
• Save the screen.

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Upload Revised Protocol

• Click Reset to delete the protocol, prior to
  initial submission only.
• Click Edit to upload the revised clean
  protocol.
• Click Add to upload the tracked changes version
  in the designated field when the IRB requests
  revisions, or for changes in research.
• Click Edit to upload new tracked changes
  revisions and replace the previous version when
  the IRB requests revisions.
• Only one version of each document should be
  visible.
• Save the screen.

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Consent Form
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Informed Consent

• Select the type of consent planned for your
  study.
• Click Continue.
• You will only see the screens relating to your
  selection.

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Download Consent Form Template

• Click the icon to download the HIPAA
  consent form template.

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Download Consent Form Template

• Right click the consent form template link.
• Save the form to your local drive.
• Use a simple name including the upload date.
• Consent Sample_102008.doc
• The IRB will modify the name you give your
  approved consent form.
• The modified name will appear in all letters.
• Complete the consent form and save it to your
  local drive.

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Upload Consent Form

• The consent form field displays the colored bars
  that indicate a multiple upload field.
• An unlimited number of consent forms may be
  uploaded.
• Click the Information Technology icon for
  step by step directions.

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Upload Consent Form

• The consent form field displays the colored bars
  that indicate a multiple upload field.
• An unlimited number of consent forms may be
  uploaded.
• Click the Information Technology icon for
  step by step directions.

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Upload Consent Form

• The consent form field displays the colored bars
  that indicate a multiple upload field.
• An unlimited number of consent forms may be
  uploaded.
• Click the Information Technology icon for
  step by step directions.
• Click Add to upload the completed consent form.
• Only one version of each consent form should be
  visible.
• Save the screen.

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Upload Revised Consent Form

• Click Edit to upload the tracked changes
  version into the consent form field when
  requested by the IRB, or for changes in research.
• This replaces, but does not delete, the previous
  version of the same consent.
• Only one version of each consent form should be
  visible.
• A clean version of the consent form is not
  needed.
• Use Edit to upload new tracked changes
  revisions and replace previous versions when
  requested by the IRB.
• Save the screen.

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Document History

• Click the small icon located beside the document
  name.
• This opens the document history window.

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Document History Window

• Select the uploaded file name to open the
  document.

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Upload Revised Consent Form

• Click Edit to upload the tracked changes
  version into the consent form field when
  requested by the IRB, or for changes in research.
• This replaces the previous version of the same
  consent.
• Only one version of each consent form should be
  visible.
• A clean version of the consent form is not
  needed.
• Use Edit to upload new tracked changes
  revisions and replace previous versions when
  requested by the IRB, changing the title date to
  reflect the new upload date.
• Save the screen.

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Upload Revised Consent Form

• Do not delete consent forms once the application
  has been submitted.
• Deleting the consent form will delete the entire
  history of the document.
• Every document uploaded in that field will be
  deleted.
• Use Edit to upload new versions and replace
  previous versions, changing the title date to
  reflect the new upload date.
• Only one version of each consent form should be
  visible.
• A clean version of the consent form is not needed
  when uploading revisions.
• Save the screen.

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Locate Approved Consent Form

• The IRB will upload a clean, approved consent
  directly into this application question.
• This consent is to be used with changes in
  research.
• Only one version of each consent form should be
  visible.

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Supplemental Study Documents

• You may be using other documents that require IRB
  approval.
• Upload supplemental study documents that require
  the JHM IRB approval logo into question 1.0.
• The IRB will upload the approved documents (but
  without the JHM IRB approval logo) directly into
  this application question.

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Supplemental Study Documents

• These documents are to be used with changes in
  research.
• Only one version of each document should be
  visible.
• These documents will be listed in the approval
  letter.
• Use Edit to upload new tracked changes
  revisions and replace previous versions when
  requested by the IRB, or for changes in research.
  
• Save the screen.

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Supplemental Study Documents

• Upload supplemental study documents that do not
  require the JHM IRB approval logo into question
  2.0.
• These documents will not be listed in the
  approval letter.
• Only one version of each document should be
  visible.
• Use Edit to upload clean, revised documents and
  replace previous versions.
• Save the screen.

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Locate Stamped Documents

• Application Workspace application approved
• Select the Stamped Documents tab.
• Scroll down to the desired section.
• Right click the documents to download.
• Use these stamped documents with study
  participants.

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Application Complete
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Application Complete

• Application Documents
• Displays all documents uploaded into the
  application, but not those located in drill down
  screens.
• Documents MAY NOT be uploaded on this screen.
• Documents MAY be downloaded from this screen.
• Click Continue to advance to the last application
  screen.

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Application Complete

• Click Finish
• This returns you to the Application Workspace.
• Finish indicates the last page of the
  application.
• You may continue to edit the application until it
  is submitted.

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Request Study Team Participation

• Application Workspace
• Select Request Study Team Participation from the
  Current Activities section.
• This opens the Request Study Team Participation
  Window.

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Request Study Team Participation

• Optional comments may be entered into the text
  box.
• Click OK. This sends out an email notification
  to everyone on the study team asking them to
  login to eIRB and complete the Agree to
  Participate activity.
• Study team members may complete the Agree to
  Participate activity without having received the
  courtesy email notification.

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Study Team Agree to Participate

• Select the Agree to Participate activity from the
  Current Activities section of the left navigation
  bar.
• This opens the Agree to Participate window.

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Study Team Agree to Participate

• Read the Agree to Participate window content.
• Click Yes.
• Click OK.
• Performing this activity is the equivalent of an
  electronic signature.
• The PI does not complete the Agree to Participate
  activity.
• Submitting the application is the PIs agreement
  to participate.

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Application Waiting to be Submitted

• The PI will receive an email notification when
  all study team members have agreed to
  participate.
• The History Log may also be checked to determine
  when all study team members have agreed to
  participate.
• The PI may submit without having received the
  courtesy email notification, once all study team
  members have completed the Agreed to Participate
  activity.

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Submit the Application

• Select Submit PI Only from the Current
  Activities section.
• This opens the submit window.

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Submit the Application

• Submit Window
• Add comments or documents ONLY for information
  NOT included in the application.
• Click OK to submit. This is the equivalent of an
  electronic signature.
• The PI does not complete the Agree to Participate
  activity.
• Submitting the application is the PIs agreement
  to participate.

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Application Submitted

• Application Submitted
• View the History Log to monitor the progress of
  the application through IRB Review.
• Click My Home to return to the Investigator Home
  page.

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Application Submitted

• Select the In Process tab.
• Scroll down to the New Applications section.
• Monitor the progress of your application through
  IRB Review.
• Upon approval by the IRB the application will
  appear under the Approved tab.

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Respond to IRB Issues
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Locate an Application/FSA

• Select My IRB Studies on the left navigation bar.
• Locate the Action Required tab on the Study Team
  Workspace.
• Scroll down to the appropriate section.
• Select the study name.
• This opens the study workspace.

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Study Workspace

• Review List
• Displays the meeting date, review date, review
  type, outcome, letter, and response.
• Select View Letter to open the letter containing
  the IRB issues to be addressed.

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IRB Letter

• Read the issues and comments.

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Respond to IRB Issues

• Select the View/Edit link to open the
  application/FSA.
• Click Continue to move from screen to screen and
  complete the IRB requested changes.

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Respond to IRB Issues

• Download and save to your local drive any
  document to be changed.
• Revise the document and save it to your local
  drive.
• Use a simple file name including the current
  upload date.
• HIPAA 4_122008.doc
• Select EDIT beside the document name to upload
  the revised version.
• Only one version of each document should be
  visible.
• Save the screens.

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Respond to IRB Issues

• Select Respond to Issues from the Current
  Activities section.

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Respond to IRB Issues

• Use the scroll bar to locate the issues listed in
  the IRB letter.
• Enter a response to each issue.
• Click the arrow to expose the formatting tool
  bar. Use the tools to format the text in your
  response.
• Click OK to close the window and save your
  response.
• This does not submit the response.
• You may continue to edit the response to issues
  until the PI resubmits.

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Respond to IRB Issues

• Check the response complete box once a response
  has been entered for each issue.
• This sends an email reminding the PI to submit.
• The PI may submit without having received the
  courtesy email notification.
• Click OK to close the window and save your
  response.
• This does not submit the response.

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Respond to IRB Issues

• Do not delete the letter from the textbox. It
  cannot be retrieved.
• Some browsers are unable to support the rich text
  format of the Respond to Issues window.
• Use a workstation that with Internet Explorer or
  Firefox as its browser.

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Respond to IRB Issues Submit

• Select Submit PI Only from the Current
  Activities section.
• This opens the submit window.

102
Respond to IRB Issues Submit

• Submit Window
• Add comments or documents ONLY for information
  NOT included in the application.
• Click OK to submit. This is the equivalent of an
  electronic signature.

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Respond to IRB Issues Submitted

• Application/FSA Submitted
• View the History Log to monitor the progress of
  the application/FSA through IRB Review.
• Click My Home to return to the Investigator Home
  Page.

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Further Study Actions
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Further Study Actions

• All actions on an approved study fall under the
  umbrella term Further Study Action (FSA).
• This includes
• Continuing Review
• Changes in Research
• Including INDs with Changes in Consent Form or
  Protocol
• Problem Events
• Emergency Use
• Termination/Post Termination Reports

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Further Study Actions

• Different types of FSAs for the same study may be
  submitted at the same time.
• A second FSA of the same type for the same study
  may not be submitted until the first has
  completed its review.
• Problem Events may be submitted at any time.
• IND Safety Reports with no changes to consent
  forms or protocol are not submitted as FSAs.

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Create a Further Study Action

• Select My IRB Studies from the left navigation
  bar.
• Select the Approved tab on the Investigator Home
  Screen.
• Scroll down to the New Applications section.
• Select the currently approved study.
• This opens the Application Workspace.

108
Create a Further Study Action

• Application Workspace
• Locate the Create FSA section.
• Click the small down arrow located under the
  Create FSA section heading.
• Select the type of FSA to be created.

109
Create a Further Study Action

• Click the Create button.
• This will open the further study action screen.
• Further study action screens, workspaces, and
  activities look and function like the application
  screens, workspace, and activities.

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Further Study Action Workspaces
111
Further Study Action Workspaces
112
Locate a Further Study Action Application
Workspace

• Select the Further Study Actions tab on the
  Application Workspace.
• This displays a list of all further study
  actions.
• Scroll down.
• Select the further study action name.
• This opens the further study action workspace.

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Locate a Further Study ActionInvestigator
Workspace

• Select My IRB Studies from the left navigation
  bar.
• Select the appropriate tab.
• Scroll down to the further study action sections.
• Select the further study action name.
• This opens the further study action.

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Computer Lab Login
320 SON Computer Lab Johns Hopkins Medical Campus
B 402 IS Computer Lab Bayview Medical Campus

• Login ID student
• Password student09
• Log onto Nursing

• Username
• Password TrainUser
• Log onto

Login to eIRB e-irb.jhmi.edu Username your
JHED ID Password your current JHED
password Accept all security warnings.
115
eIRB 101 Prepare and Submitan eIRB Application

• Stephanie Gaudreau
• Joyce Lederman
• jhmeirb_at_jhmi.edu