Further Study Actions

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Further Study Actions

• jhmeirb_at_jhmi.edu

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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 Requests
• Termination Report/Post Termination Reports

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Further Study Actions

• Continuing Reviews, Changes in Research,
  Emergency Use Requests, and Termination
  Report/Post Termination Reports 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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eIRB Login

• Login to eIRB at http//e-irb.jhmi.edu.

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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.

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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.

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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
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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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Further Study Actions

• jhmeirb_at_jhmi.edu