Create Termination Post Termination Reports

1
Create Termination/Post Termination Reports

• jhmeirb_at_jhmi.edu

2
Termination/Post Termination Reports

• Termination report
• Study activity is completed and
• Access to study identifiers (if applicable) is no
  longer required for data analysis or manuscript
  writing.
• Post Termination Report
• Submission of information relevant to the study
  after the study is terminated.

3
eIRB Login

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

4
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

5
Investigator Home Page

• Investigator Tabs
• Lists your studies by their current state in the
  submission/review process.
• Studies List
• Displays all of your studies.

6
Investigator Home Page

• Locate the appropriate tab on the Investigator
  Home Page.
• Scroll down to the New Applications section.
• Select the name of the currently approved study.
  
• This opens the application workspace.

7
Create Termination/Post Termination Report

• Click the small down arrow located under the
  Create FSA section heading on the application
  workspace.
• Select Termination Report

FSA
8
Create Termination/Post Termination Report

• Click the small down arrow located under the
  Create FSA section heading on the Application
  Workspace.
• Select Termination Report
• Click the Create button.
• This opens the initial termination/post
  termination report screen.

FSA
9
Termination/Post TerminationReport Screens

• Blue Title Bar

10
Termination/Post TerminationReport Screens

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Saves your work and moves you through the change
  in research 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 Change in
  Research Workspace.
• Print
• Allows you to print the current section of the
  change in research.

11
Termination/Post TerminationReport Screens

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Back
• Save
• Exit
• Print
• Hide/Show Errors
• Displays errors and provides links to screens.
• Jump To
• Does not save. Displays list of screens used to
  navigate to non-consecutive screens.

12
Termination/Post TerminationReport Screens

• Complete each screen.
• Click Continue to save the current screen and
  advance to the next screen.

13
Required Field

• Required
• The red asterisk indicates a required field
  that MUST be completed.
• You will not be able to submit the report until
  all required fields on each screen have been
  answered.

14
Help Tools

• Help Tools appear beside each question.

15
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.

16
Termination/Post TerminationReport Screens

• Select Termination or Post Termination Report.
• Click Continue to save the current screen and
  advance to the next screen.

17
Termination/Post TerminationReport Complete

• Click Finish
• This returns you to the termination report
  workspace.
• Finish indicates the last page of the report.
• You may continue to edit the report until it is
  submitted.

18
Termination/Post Termination Report Workspace

• Report Waiting to be Submitted
• Disappears upon submission.
• Study Vital Statistics
• Displays the report name, report number, date
  submitted, and date acknowledged.
• Termination Report Current Status
• Displays the current state of the report in the
  submission/review process.

19
Termination/Post Termination Report Workspace

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

20
Termination/Post Termination Report Workspace

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

21
Termination/Post Termination Report Workspace

• Left Navigation Bar
• Divided into two sections.
• View/Print Problem Event
• Current Activities
• Displays a list of activities that may be
  completed.

22
Termination/Post Termination Report Workspace

• View the Termination Report Current Status box to
  monitor progress through the IRB review process.
• Select View/Edit Termination Report to open an
  existing report.
• Use the Current Activities to submit/withdraw the
  report.
• Use the History Log to track activities.
• Use the Review List to retrieve the meeting
  outcome letter.

23
Termination/Post TerminationReport Complete

• Select My Home to return to the Investigator
  Home page.

24
Locate a Termination/Post Termination Report

• Select the Researcher Prep tab.
• Scroll down to the Termination Reports section.
• Select the report name.
• This opens the termination report workspace.

25
Create Termination/Post Termination Reports

• jhmeirb_at_jhmi.edu