Protocol

1
Protocol

• jhmeirb_at_jhmi.edu

2
Forms in eIRB

• New protocols must be on the current eForm A
  template.
• Download the eForm A template from within the
  eIRB application on the Protocol Information
  screen.

3
Forms in eIRB

• Only electronic forms are accepted in eIRB.
• Paper copies of the protocol must be scanned and
  converted into an electronic copy in Adobe
  Acrobat (.pdf), MS Word (.doc), or HTML (.html)
  format.
• 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.
• eIRB requires the three character file-type
  extensions to file names before uploading into
  eIRB.

4
Help Tools

• Help Tools appear beside each question.

5
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.

6
Download eForm A

• Click the icon .

7
Download eForm A

• Right click the link to eForm A.
• Save the form to your local drive.
• Title Use a simple name including the upload
  date.
• The name you give your document is the name that
  will appear in all letters.
• eFormA_102008.doc
• Complete eForm A and save it to your local drive.

8
Upload Protocol

• The protocol field is a single upload field.
• It does not display the colored bars that
  indicate a multiple upload field.

9
Upload Protocol

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

10
Upload Protocol

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

11
Upload Protocol

• Click Add
• Submit a Document Window
• Browse
• Select the protocol document saved to your local
  drive.
• Leave the title field blank. eIRB will use the
  file name for the title.
• Use a simple file name including the upload date.
  
• The name you give your file is the name that will
  appear in all letters.
• eForm A_102008.doc
• Click OK

12
Upload Protocol

• Save the screen.

13
Delete Protocol

• Delete the protocol from eIRB only prior to
  initial submission.
• Click Reset to permanently delete the protocol
  from eIRB.
• Save the screen.

14
Revise Protocol

• Right click the protocol name.
• Save the protocol to your local drive.

15
Revise Protocol Tracked Changes

• Open the saved document
• Access the track changes function of MS Word.
• Complete the revisions.
• Changes will be clearly displayed.
• Save the revised protocol to your local drive.
• Indicate tracked changes in the file name.
• Change the upload date.
• eForm A_tracked changes_122008.doc

16
Revise Protocol - Clean

• Accept all of the changes.
• Turn off the track changes function of MS Word.
• Save the revised protocol to your local drive.
• Indicate clean in the file name.
• eForm A_clean_122008.doc
• There are now three copies of the protocol saved
  to your local drive
• The old version.
• The revised version displaying tracked changes.
• The revised clean version.

17
Upload Revised Protocol

• Do not delete previous versions of the protocol.
• Click Edit to upload the revised clean
  protocol.
• Save the screen.

18
Upload Revised Protocol

• Click Add to upload the tracked changes version
  in the designated field when the IRB requests
  revisions or for changes in research.
• Do not delete previous document versions .
• Click Edit to upload new tracked changes
  revisions and replace the previous version when
  requested by the IRB or for changes in research.
• Only one version of each document should be
  visible.
• Save the screen.

19
Protocol

• jhmeirb_at_jhmi.edu