eIRB: General Reference Guide

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eIRB

General Reference Guide

eIRB Home: http://eIRB.mc.duke.edu

eIRB Technical Support: eIRB@mc.duke.edu

Institutional Review Board

Duke University Medical Center

IRB Office: http://irb.mc.duke.edu

IRB Office Phone: (919) 668-5111

1Introduction

1System Requirements

1System Configuration

1How to Set the Size of Letters

1How to Configure your Browser to Use Microsoft Word to Open Documents

2How to get an eIRB Account

2How to Log in

3Navigating eIRB

3The eIRB Banner

3Your Name

3My Home

3Login / Logoff

3eIRB Home

3Administration

3Studies

4Exploring Your Personal Workspace

4My Home

4My Roles

4Viewing All of Your Studies

4How to Use the Display Tabs

5Finding a Study

5How to View Studies Awaiting Your Action

5How to Search for Studies using Filtering Criteria

5How to Sort Studies

5Exploring the Study Workspace

5Study Header

6Application Pages

7Review Status

7Actions Available

7Tabs

8Exploring the Amendment Workspaces

8Amendment Workspace

9Modified Study Workspace

10Exploring the Safety Event Workspace

11Safety Event Header

11Safety Event Pages

11Exploring the Continuing Review Workspace

11Continuing Review Header

12Continuing Review Pages

12Using the eIRB: How To and Tips

12Tips for Completing Study Pages

12Required Fields

12Tips for Selecting People

12How to Add People to Study Pages

13How to Remove People from Studies

13How to Find People to a Add to a Study

13Tips for Finding Funding Source, Sponsor, Drug or Device Source

14Tips for Attaching Documents

14How to Find Attached Documents

14How to View an Attached Document

14How to Attach a Document

14How to Replace an Attached Document with an Updated Version

14How to Detach All Versions of a Document

14Tips for Naming Attached Documents

15How to Save Email Correspondence

15How to Manage Paper Documents

16Attaching Other Media

16Tips for Consent Forms

16How to Copy the eIRB Consent Form Template

16Tips for Responding to Reviewer Requests

17Tips for Using Microsoft Word

17Tips for Getting Help with Microsoft Word

17Tips for Tracking Changes to a Document

18Tips for Reviewing Tracked Changes

18Tips for Accepting and Rejecting Tracked Changes

18Tips for Comparing Documents

19Troubleshooting

19Getting Started

20Getting Help

20Login Help

20FAQ

20User Gudies

20eIRB Support

20System Maintenance

20Emergency Preparedness

Introduction

The eIRB is a software application that enables researchers to submit human subject research protocols to the DUHS Institutional Review Board online, using a web browser. The eIRB Home page address is: https://eirb.mc.duke.edu. Protocols submitted in the eIRB are routed, reviewed, and finalized electronically.

This General Reference Guide gives you basic information that will familiarize you with using the eIRB. In the User Guides section of the eIRB Home page, there are role-specific user guides with detailed, step by step instructions for eIRB activities.

System Requirements

To use the eIRB system, youll need the following:

An eIRB account

Compatible web browsing software. Currently the following web browsers are fully supported:

Internet Explorer version 7 or higher

Mozilla Firefox version 3 or higher

Apple Safari version 4 or higher

Sun Microsystems Java software

Software capable of reading Microsoft Word 2007 (.docx) documents

Software capable of reading .pdf documents

An active internet connection

System Configuration

How to Set the Size of Letters

The recommended minimum screen resolution for eIRB is 1024 X 768. To change your resolution, go to the Display Control Panel and click the Settings tab. Move the screen resolution slider to 1024 X 768, and click the Apply button.

How to Configure your Browser to Use Microsoft Word to Open Documents

In eIRB, many documents are attached, much like e-mail attachments. You can configure your browser to open documents in specific software applications, such as Microsoft Word, based on the file extension. Otherwise, your browser might open attachments in the browsers extensions which do not have full functionality.

To configure Internet Explorer to use Word to open Word documents:

1. Open My Computer.

2. On the Tools menu (or the View menu), click Folder Options (or click Options).

3. Click the File Types tab.

4. In the Registered file types list, scroll to the DOC extension (Microsoft Word Document) row, and select.

5. Click Advanced (or click Edit).

6. In the Edit File Type dialog box, click to clear the Browse in same window check box (or click to clear the Open Web documents in place check box).

7. Click OK.

8. Click Close.

How to get an eIRB Account

On June 1, 2011, we implemented a new process for creating new accounts in the eIRB.

First, please complete the Duke Human Subjects Protection (HSP) training requirements.

For information about the training requirements, see http://medschool.duke.edu/modules/som_research/index.php?id=10.

One to two business days later, an eIRB account will be automatically created for you.

How to Log in

1.In your internet browser, browse to the eIRB Home Page at:

https://eirb.mc.duke.edu

2.At the eIRB Home page, type your NetID and password in the appropriate fields in the column on the right side of the page.

3.Click the Login button.

If your login is successful, you will see your name on the right side of the top blue banner.

If your login is not successful, click the Log In Help link on the eIRB Home page, or see the logging in sections of the eIRB Troubleshooting Guide in the User Guides section of the eIRB Home page.

Navigating eIRBThe eIRB Banner

The eIRB banner, the Duke blue area across the top of the page, contains several navigational links.

Your Name

The name link in the top right of the blue banner displays your contact information. This information is loaded from Duke institutional databases, and must be updated at the source. Directory information can be updated at Online@Duke, at www.duke.edu/online. You might need to contact your departmental payroll or human resources representative about updating your contact information.

My Home

The My Home link, located in the top right of the blue banner, displays your eIRB task-list. The task-list displays eIRB items that are awaiting your action. If you have more than one role in the eIRB, you will have a separate task-list for each role. You can switch between roles using the links in the left column of your workspace.

Login / Logoff

The Login / Logoff links in the top blue banner log you in or off of the eIRB.

eIRB Home

The eIRB Home link is on the left side of the top blue banner. The eIRB Home page displays news and information about the eIRB, and contains links to helpful information such as the User Guides and Downloadable eIRB Forms.

Administration

The Administration link in the top blue banner gives Organization administrators access to all of the studies in their Organization, as well as related Amendments, Safety Events and Continuing Reviews. Studies are divided into folder tabs based on review status.

Studies

The Studies link in the top blue banner gives study team members access to all of their studies and related Amendments, Safety Events and Continuing Reviews. Studies are divided into folder tabs based on review status.

Exploring Your Personal Workspace

My Home

When you log in to the eIRB or click the My Home link at the right of the top blue banner, you see your personal workspace. Personal workspaces are designed to help you manage your eIRB work.

Workspace for [your name] heads the page

The My Roles column at the left shows the roles assigned to you

A Tasklist folder tab shows the eIRB items that are awaiting your action

To return to your personal workspace at any time, click the My Home link in the top blue banner.

My Roles

If you have more than one role assigned to you in the eIRB, the study and task-list information you see depends on the selected role. The selected role shows in the color bar at the top of the left column, and as the role in Bold under the My Roles heading.

To view the workspace for a different role, click that role name under the My Roles heading.

To view all eIRB items awaiting your action, you will need to select each different role you have, and view each task-list.

Viewing All of Your Studies

Click the white Studies link in the top blue banner to find studies to which you have access as a member of the study staff ( PI, Co-PI, Study Coordinator, Faculty Sponsor, Other Key Personnel).

Click the white Administration link in the top blue banner to find studies to which you have access as an administrator (e.g. Department Chair, Research Support Office).

These studies might not require action, but you always have access to view them through the Studies or Administration link.

To view all Amendments, Continuing Reviews or Safety Events, click those links from the column at the left Studies page.

How to Use the Display Tabs

The All tab displays all studies to which you have access, in any state of review.

The In Progress tab displays your studies under review.

The Approved tab displays active studies.

The Inactive tab displays your studies that have been closed or withdrawn.

Finding a StudyHow to View Studies Awaiting Your Action

Click the My Home link in the top right of the blue banner. The eIRB task list displays all studies that are awaiting action by your or by someone with your role in the eIRB.

If you have more than one role under the My Roles heading in the column at the left, you have a Task list for each role. Click the name of each role to view studies awaiting action by you or someone with your role in the eIRB.

How to Search for Studies using Filtering Criteria

Within each study folder (All, In Progress, Approved, Inactive), you can search for one or more studies by using criteria as filters.

The default way to search for a study is by Protocol ID number. Type the number (e.g. Pro00000001) in the text box in the light blue header and click the Go button.

To change the criteria for selecting studies, click the Filter By drop down arrow. select an item to filter by (e.g. PI), enter the criteria in the text box, and click the Go button.

If you only know part of the criteria, you can use the % wildcard, (e.g. Filter by Name, type %asthma in the text box and click Go).

How to Sort Studies

Studies are sorted by Protocol ID, in ascending order. To change the sort order, click the column heading on which you want to sort. Click the column heading link again to sort in the opposite order.

Exploring the Study Workspace

The study workspace is the home page for a study. You see the study workspace when you click on the study name from your home page or the Studies link.

The study workspace gives you information about where the study is in the review process, as well as access to the study application pages and all information associated with the study.

Study Header

The study header is the rows of information in the top middle of the workspace that displays identifying information about the study. The amount of information displayed in the header changes as the study goes through the review process.

The study header always displays:

Study - the short title of the study

Protocol ID - the protocol ID number Proxxxxxxxx

Full Study Title

Study Organization - the organization responsible for the study

SBR Site Based Research organization

Prinicpal Investigator

Study Coordinator

Funding Source(s)

Protocol Source(s)

Review Type the IRB review type: Expedited, Full Committee, or Exempt

Primary Reviewer

Review Date

Current Expiration Date

Letter of Approval [View] link to approval of new study

Application Pages

Printer Friendly Version

The printer friendly version displays the study application pages in a scrollable format that is more suitable for printing.

To scroll through the study pages, click in the scroll bar to the right of the window

To view an attached study document, click the name link to open the document. Click the X at the top right of the document to close it.

To print the view, scroll to the top and click the Print button

To close the view and return to the study workspace, scroll to the top and click the Close button

View Study

To display the study application pages one at a time, click the View Study or View / Edit Study button in the column at the left of the study workspace. Your role on the study and the current state of the study determine whether or not the study is editable.

The protocol number shows at the top right of the study application pages.

To move through the study pages, click the Continue and Back buttons.

To view an attached study document, click the name link to open the document. Click the X at the top right of the document to close it.

To jump to a different study page, click the arrow next to the Jump To: drop down box.

To save the study page, click the Save link in middle of the top light blue banner.

To exit the study pages and return to the study workspace, click the Exit link in the middle of the top light blue banner.

Review Status

There are three areas of the study workspace that show the review progress and current status:

Current State

The Current State in the white rectangle at the top of the column to the left column shows the review status of the study.

History Tab

The History tab in the bottom half of the study workspace shows the review activities. Each activity shows the name of the person who executed the activity, and when.

The review activities display in order, with the most recent activities at the top.

To see continuation of comments, click the activity link. Click the Back button in your browser to return to the History tab.

Actions Available

The links under the Actions Available header in the left column of the study workspace show the review activities that are available to you. Actions include Submit Study, Submit Changes, etc. Your role on the study and the review status determine the actions available.

Tabs

Additional tabs are available, depending on the review status of the study.

Study Documents

The Study Documents folder tab is a shortcut view to all documents attached to the study, such as research summary, consent forms, and protocol documents.

Information

The Information folder tab is a shortcut view to information from the study pages.

Required Approvals

The Required Approvals folder tab shows the names and/or organizations of the study reviewers that are required and received.

Amendments

For approved studies, the Amendments folder tab shows amendments to the study. To view an amendment and its review information, click the name of the amendment to go to its workspace.

Safety Events

For approved studies, the Safety Events folder tab shows Adverse Events, Protocol Deviations, and Correspondence and Other Problems/Events that Require Prompt Reporting to the IRB. To view a safety event and its review information, click the name of the safety event to go to its workspace.

Continuing Reviews

For approved studies, the Continuing Review folder tab shows Continuing Reviews, including the Annual Progress Report and Final Progress Report, if applicable. To view a continuing review and its review information, click the name of the continuing review to go to its workspace.

Modifications

The Modifications folder tab shows all required modifications, if applicable.

Change Log

The Change Log folder tab shows all changes made to the study by Study Staff after PI signature.

Exploring the Amendment WorkspacesAmendment Workspace

The amendment workspace is the home page for an amendment. You see the amendment workspace when you click on an amendment name from your home page, the Amendments folder on a study workspace, or the Amendments link from the Studies link in the top blue banner.

The amendment workspace gives you information about where the amendment is in the review process, and access to the Modified Study workspace. The Modified Study is a copy of the Original Approved study. The Modified Study must contain all of the changes proposed in the Amendment Request Form. When the amendment is approved by the IRB, the Modified Study becomes the Approved study.

The amendment workspace is similar to the study workspace, but has some unique features.

Amendment Header

The amendment header always displays:

Amendment: - AMD # - the short title of the approved study plus (Amd#_Pro00000xxx) the amendment sequence number and the Protocol number of the approved study

From the Original Approved study (the Parent Study of the amendment):

Protocol ID

Short Title

Approval Date

From the Modified Study:

PI - the person who will be the Principal Investigator when the amendment is approved

Study Coordinator the person who will be the Study Coordinator when the amendment is approved

Amendment Form

The amendment form is the one-page Amendment Request Form that describes the proposed changes to the study.

Modified Study Workspace

The Modified Study has its own workspace. The modified study workspace displays when you click on the To Modified Study Workspace button from the amendment workspace. Changes proposed in the amendment must be made to the application pages of the Modified Study.

The modified study workspace gives you information about the changes that have been made to the Modified Study, and access to the Modified Study application pages.

Modified Study Header

The modified study header always displays:

Modified Study and Change Log for: The number and name of the amendment, AMD# plus the short title of the study

Modified Study #: MS# plus the Protocol number of the original study

Amendment created date

Amendment review status

Modified Study Application Pages

When you View or Edit Modified Study, the pages containing the changes in the proposed amendment display. On page 01. Study title and Research Personnel, the Short Title is the short title of the Original Approved version, plus (modified study).

Modified Study Folders

Change Log

The Change Log allows you to see the differences between the Original Approved study and the Modified Study as proposed in the amendment.

All changes display, in date order, with the most recent activities first.

To view the changes, click the Notepad icon ().

To return to the Modified Study workspace, click the Back to Change Log button at the top right.

Notes: If there are multiple entries in the History for each study page, you only need to view the Change Log of the most recent entry for that page.

The Change Log cannot highlight all of the information on the Detail pages. For Drugs, Devices, and Subject Recruitment Detail pages, you must look at and compare the information on the pages and the modified dates for attached documents.

Study Documents

The study documents attached to the Modified Study.

Exploring the Safety Event Workspace

The safety event workspace is the home page for the safety event. You see the safety event workspace when you click on a safety event name from your home page, the Safety Events folder on a study workspace, or the Safety Events link from the Studies link in the top blue banner.

Safety Events include:

Adverse Events

Protocol Deviations

Correspondence

Other Problems or Events Requiring Prompt Reporting to the IRB

Safety Event Header

The safety event header always displays:

Safety Event Type Adverse Event, Protocol Deviation/Violation, Correspondence or Other Problem/Event Requiring Prompt Reporting to the IRB

Event Name

Event Description

Protocol Name the short title of the study

Protocol ID the Protocol ID number Proxxxxxxxx

Safety Event ID the Safety Event ID, eg. SAE001_Proxxxxxxxx

Date Event Occurred

Principal Investigator

Study Coordinator

Review Date

Action Notice [View] link to IRB action notice

Safety Event Pages

You can View or Edit the Safety Event pages one page at a time, or use the Printer Friendly Version to display the pages in a scrollable format that is suitable for viewing and printing.

Exploring the Continuing Review Workspace

The continuing review workspace is the home page for the continuing review. You see the continuing review workspace when you click on a continuing review name from your home page, the Continuing Reviews folder on a study workspace, or the Continuing Reviews link from the Studies link in the top blue banner.

Continuing reviews include:

Continuing Review Progress Reports (renewals)

Final Progress Reports (closure)

Continuing Review Header

The continuing review header always displays:

Continuing Review CR#: Short Title of the study

Protocol ID

Full Study Title the full title of the study

Principal Investigator:

Study Coordinator:

Expiration Date - expiration date of the Original Approved study

Continuing Review Pages

You can View or Edit the Continuing Review pages one page at a time, or use the Printer Friendly Version to display the pages in a scrollable format that is suitable for viewing and printing.

Using the eIRB: How To and Tips

Tips for Completing Study Pages

Required Fields

Required fields are preceded by a red asterisk. You can Save, Exit, and Jump To other study pages without completing the required fields. However, the Continue button checks for errors on the page, so you must complete the required fields to continue to the next study page. When you submit a study, all the pages are checked for required fields.

Tips for Selecting People

How to Add People to Study Pages

For some roles, such as PI, you add one person to the role. For others, such as Co-PI, you can add more than one person. These are the steps for adding people to a study.

Single Person Roles

(PI, Study Coordinator, Faculty Sponsor, Key Personnel)

1.Click the Select button.

2.On the Select Person page, find the person.

3.Click the radio button in front of the persons name.

4.Click OK.

Multiple Person Roles

(Co-PI)

1. Click the Add button.

2. On the Select One or More Persons page, find the person.

3. Click the check box in front of the persons name.

4. Click OK. If you want to add another Co-PI, click OK and Add Another.

How to Remove People from Studies

Single Person Roles

(PI, Study Coordinator, Faculty Sponsor, Key Personnel)

Click the Reset button.

Multiple Person Roles

(Co-PI)

1.Click the check box in front of the persons name.

2.Click the Remove button.

How to Find People to a Add to a Study

On the Select a Person window, type any part of the persons Last Name in the text box and click the Go button. The list is sorted by Last Name only. To sort by First Name too, click the First column heading.

To find people within common last names, or to search using different click the Advanced link to the right of the text box. Type any part of the persons Last Name and First Name and click the Go button.

To search by criteria other than Last Name, click the drop down box next to Filter by, select the item to filter by, enter the criteria in the text box, and click the Go button.

If you are adding people to an Approved study, they will not appear on the list unless their Human Subjects Protection (HSP) certification is current.

If you are adding people to a new study and cannot find them, they might not have been loaded properly, or might not have been assigned the required role. Please send email to eIRB Support at: eIRB@mc.duke.edu.

Tips for Finding Funding Source, Sponsor, Drug or Device Source

On the Select a ? window, type any part of the name in the text box and click the Go button. The list is sorted by ? To sort by another column, click the column heading.

If you cannot find a match, the entity will need to be added to the eIRB database. Send email to eIRB Support at: eIRB@mc.duke.edu.

Tips for Attaching Documents

Study documents and reviewed documents are attached in a way that is similar to adding attachment to e-mail.

Many reviewers use Track Changes in Microsoft Word to indicate required changes to study documents. Please attach the Research Summary, Consent Forms, and Waivers as Microsoft Word documents that are editable.

How to Find Attached Documents

Documents attached by Study Staff can be found in the Study Documents folder tab of the study workspace, or on the individual Study Pages.

Documents attached by Reviewers can be found in the History folder tab of the study workspace.

How to View an Attached Document

Click the title link of the attached document

How to Attach a Document

1.Click the Add button.

2.Click the Browse button.

3.Navigate to the file that you want to attach, select it, and click Open.

4.Click OK on the Submit a Document window.

How to Replace an Attached Document with an Updated Version

1.Click the Update Revision link in front of the title of the attached document.

2.Click the Browse button.

3.Navigate to the file that you want to attach, select it, and click Open.

4.Click OK on the Submit a Document window.

How to Detach All Versions of a Document

1.Click the check box in front of the title of the attached document.

2.Click the Delete button.

Tips for Naming Attached Documents

In the eIRB, you can retain multiple versions of the same document. The attachment Title is not the same as the File Name. The Title is a pointer to the attached files, some of which have different file names, e.g. ICF Minor Ver. 1.5.doc, ICF Minor Ver. 1.6 tracked.doc, etc.

When you first attach a document, if you leave the Title field blank, the eIRB uses the file name, e.g. ICF Minor Ver. 1.5.doc as the Title. However, you might decide to type in a more generic Title instead, such as Minor Consent or Adult Consent. Then, when you attach different files, revised versions of the same document, you dont have to revise the Title.

When you Edit an attachment to attach a revised version of a document, if you leave the Title field blank, the existing Title is retained. It does not change to match the file name of the newly attached document.

How to Save Email Correspondence

You can save Lotus Notes email correspondence as a text file so it can be attached in the eIRB:

1. Open the email correspondence

2. Click File, Export

3. Type the file name and click OK.

Be sure to name the file with a .TXT extension at the end. This will allow the eIRB to recognize the file as generic text.

Attach the saved text file as you would any other document. For details, see the How to Attach a Document section of this document.

Note: If you have Adobe Acrobat installed (Adobe Reader is not sufficient), you can save correspondence with the formatting preserved:

1. Open the email correspondence

2. Click File, Print

3. Select Adobe PDF as the printer and click OK.

4. Revise the file name if needed and click Save.

How to Manage Paper Documents

All documents must be attached in eIRB in electronic format. This includes investigator brochures, patient diaries, and protocols. Please request electronic documents from sponsors. If you cannot obtain electronic copies, they must be scanned.

We recommend saving scanned documents in PDF format rather than TIF, especially large documents.

You can use a third party for large jobs, such as the Duke Copy Center on Kangaroo Drive. Contact Della Atkins at the Copy Center for more information. New customers to the Duke Copy Center will need to set up a new account with the following information: department name, fund code, the name, Duke box number, phone, and fax number for the person responsible for the fund code. Another option is Kinkos on Ninth Street. They will scan to disk as a PDF file for 30 cents/page for 1 -100 pages, with a $10 min. There is a 24-hour turnaround. Color scanning costs more.

Attaching Other Media

Any electronic media can be attached in the eIRB, including image files and Windows media files such as AVI and MPG files. If you have media that you cannot submit in electronic format, go to the study page on which you would normally attach the media, and attach an explanation of the circumstance, along with a label identifying the material. Deliver the media to the IRB office, clearly labeled with the media label, the study name, the PI name, and the eIRB Protocol ID number.

Tips for Consent Forms

In the eIRB consent forms must have the eIRB-specific footer. The consent form footer is used by the IRB office to mark the approved consent form. The footer replaces the rubber IRB stamp that is used for consent forms reviewed on paper.

How to Copy the eIRB Consent Form Template

1. In your Internet browser, go to the eIRB web site: http://eIRB.mc.duke.edu.

2.Click the Download Forms link in the left column.

3.Click the name of the appropriate consent form template.

4.Save the template on your computer

5.Type your consent form, or copy and paste it from another source, and Save.

Tips for Responding to Reviewer Requests

Reviewers can use tracked changes in Microsoft Word to request specific changes to study documents. Study Staff can use track changes to respond. Each person must make it clear to the other which changes are requested, and/or accepted. This can be challenging in an electronic world.

Submit Clean Documents

When you submit a study for review, and after each point in the review where reviewer changes or modifications are necessary, study documents should be submitted clean, without any unaccepted tracked changes.

Use Track Changes to Show Revisions

When a reviewer requests changes to a document, or the study team requests revisions, all changes must be tracked.

Use Accept / Reject Tracked Changes to Show Agreement or Disagreement

When you agree with tracked changes, accept all changes and attach a clean copy of the document on the eIRB study page. If you are responding to a request with changes, or are changing a document in any way different from the reviewers tracked changes, you can reject tracked changes, and/or track your changes and attach the revised document to the study page. Wait until you have agreement on all of the changes before attaching a clean copy of the document for final approval.

Tips for Using Microsoft Word

In the eIRB, it is useful to know how to use Microsoft Word to track and accept revisions to study documents, and to compare documents to highlight differences.

Tips for Getting Help with Microsoft Word

Context Sensitive Help

When you are in Word, you can click the Question Mark icon or use the F1 function key on your keyboard to get help with the function you are using.

Microsoft.com

Microsoft offers extensive help for using Word on their Microsft Office Online and other web sites available through Microsoft.com.

For example, this is a site for Word 2007 help: http://office.microsoft.com/en-us/word/FX100649251033.aspx

Duke Resources

Duke Learning & Organizational Development (L&OD) offers classes and workshops. For schedules, see: www.hr.duke.edu/train

Duke Office of Information Technology is piloting On line training via Lynda.com, including videos that guide you through software applications. To get involved, see: http://www.oit.duke.edu/help/training/online/

Tips for Tracking Changes to a Document

To save a copy of the file you plan to revise, on your local computer, right-click your mouse on the name, select Save Target As, browse to the place where you would like to save the document and click OK.

Open the document you saved on your computer in Word, and turn Track Changes On. In Word 97-2003, Track Changes is on the Tools menu and on the Reviewing Toolbar. To display the Reviewing Toolbar, select View, Toolbars, Reviewing.

Open Word documents using Word, instead of the Internet Explorer or other browser extensions of Word. See the Configuring Your Internet Browser section above.

You can change the way your revisions display by changing the Track Changes Options:

Show changes in Balloons that appear in the margins of the document, or In Line, in the document.

Show all changes ( e.g. include Formatting changes), or select only some.

Select where the Indicator that a line has changed displays.

Tips for Reviewing Tracked Changes

You can change the view of the document by making a selection in the using the Reviewing Toolbar drop down box:

Original displays how the original document looked before tracked changes were made.

Original Showing Markup shows the revised document view as a document marked up by hand with a pen might look. Deletions are crossed out in the text. Insertions show in the margin.

Final Showing Markup shows how the revised document will look once the changes are accepted, but with the tracked changes marked

Final shows how the document will look when all changes are accepted.

To show all tracked changes in a list, open the Reviewing Pane..

In the Reviewing Pane, double-click on the header of the change to jump to that place in the document.

Tips for Accepting and Rejecting Tracked Changes

You can accept and reject changes one at a time, or review all of the changes, then accept or reject all of them in the document at once.

Comments are not tracked changes. Comments must be inserted and deleted. They can not be accepted and rejected.

Tips for Comparing Documents

You can Compare documents in Word to find out where differences exist between documents.

You can find the answers to the questions:

What are the differences between two documents?

For example, compare two clean documents, an original and a revised version in which changes have not been tracked.

Did I track all of the revisions to the original document?

For example, compare an original and a revised document with changes tracked. All differences should show as tracked changes.

Did I accept all of the tracked changes?

For example, compare a tracked document you reviewed with a clean version. Word compares the tracked changes as if they were accepted, so there should be no differences in the documents.

In Word 97-2003, you open the revised document, then compare it to the original document saved on your local computer. In Word 2007, you open both documents from your local computer.

You can change the way differences display by changing the Compare Options:

Show differences in the Original, Revised, or a third New document.

Show all difference ( e.g. include Formatting differences), or select only some to reduce the noise in the document.

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TroubleshootingGetting Started

If you are unable to view the eIRB Home page:

See if you can access other Duke systems that would normally travel over the network, such as the IRB Office web site: http://IRB.mc.duke.edu. If you cannot get to other sites, you are probably having general connectivity problems. Contact your local computer support person or the DHTS Help Desk at 684-2243.

If you can go to other sites, make sure you have typed the correct address for the eIRB Home page in your Internet browser. The address is: http://eIRB.mc.duke.edu

If you can go to other sites, but cannot view the eIRB Home page, there might be a technical problem with the eIRB. Email eIRB Support at eIRB@mc.duke.edu.

Getting Help

Login Help

For help logging in to the eIRB, go to the eIRB Home page and click the Login Help link in the column at the right.

FAQ

For answers to frequently answered questions, go the eIRB Home page and click the FAQ link in the column at the left.

User Gudies

For step by step instructions, go to the eIRB Home page and click the User Guides link in the column at the left.

eIRB Support

If your questions are not answered in this document or by following the links above:

1. Contact your local eIRB support person. For a list, see the Department Support Contacts document in the User Guides section of the eIRB Home page.

2. Contact the Board Specialist for your department in the IRB office. For a list, see the Departments by Board Specialist and Writer section from the IRB Office link at the top of the IRB Office web site: http://IRB.mc.duke.edu.

3. Email eIRB Support: eIRB@mc.duke.edu.

If you find the performance of the eIRB unacceptable, send email to eIRB Support at: eIRB@mc.duke.edu .

System Maintenance

Announcement of eIRB unavailability for planned maintenance will be made in advance in the News section of the eIRB Home page. Before the planned maintenance begins, you should make local copies of any study information that you anticipate you will need while the system is unavailable.

Emergency Preparedness

Study personnel must maintain local copies of any eIRB study information, such as approved consent forms, that must be available if the eIRB system is unavailable.