eIRB

Research Data Security Plan (RDSP) Reference Guide

This guide contains detailed, step-by-step instructions for completing, reviewing, and approving the Research Data Security Plan RDSP) in the eIRB.

The RDSP review is managed by the owning organization (department or CRU). The RDSP is linked to the study, but is not reviewed by the IRB.

For a general introduction to the eIRB, including how to navigate the different workspaces, please see the General Reference Guide.

TABLE OF CONTENTSEXPLANATION OF CHANGES..............................................................................................................................................2

HOW TO LOG IN TO EIRB.....................................................................................................................................................2

HOW TO VIEW YOUR TASK LISTS.....................................................................................................................................4

FOR STUDY STAFF..................................................................................................................................................................6

HOW TO COMPLETE THE RESEARCH DATA SECURITY PLAN...................................................................................................6HOW TO RESPOND TO REVIEWER REQUESTS.........................................................................................................................19HOW TO REVISE AN APPROVED RESEARCH DATA SECURITY PLAN......................................................................................26

FOR REVIEWERS...................................................................................................................................................................31

HOW TO COMPLETE YOUR REVIEW........................................................................................................................................31HOW TO REQUEST CHANGES OF THE STUDY TEAM...............................................................................................................38

FOR APPROVERS AND ADMINISTRATORS...................................................................................................................41

HOW TO COMPLETE YOUR REVIEW........................................................................................................................................43HOW TO MAINTAIN PERSONNEL FOR YOUR ORGANIZATION.................................................................................................43

GETTING HELP......................................................................................................................................................................44

TECHNICAL SUPPORT..............................................................................................................................................................44eIRB Home.........................................................................................................................................................................44eIRB Email.........................................................................................................................................................................44DHTS Help Desk................................................................................................................................................................44

RESEARCH DATA SECURITY PLAN SUPPORT..........................................................................................................................44Information Security Office...............................................................................................................................................44

1

Explanation of Changes

In February 2014 Duke University options were added to page 02.2 Electronic Storage Details.

How to Log In to eIRB

1. In your internet browser, go to the eIRB Home page: http://eIRB.mc.duke.edu .

2. Type your NetID, tab to the Password field and type your NetID password. Press Enter or click the Login button .

2

Your personal workspace displays. The task list shows you any items that are awaiting your action.

3

How to View Your Task Lists

Your eIRB workspace is designed to show you work that is awaiting your action. Each eIRB role assigned to you has its own workspace.

1. To view your workspace, click the white My Home link at the right of the top blue banner.

4

The task list for the selected role displays in the main section of the window.

The selected role is shown in the colored banner at the top, and in bold text under the My Roles heading.

Your roles are listed under the My Roles heading.

To return to your Task List from anywhere in the eIRB, click the My Home link.

To view the task list for a different role, click the role under the My Roles heading in the column at the left.

5

For Study Staff

How to Complete the Research Data Security Plan

1. To create a Research Data Security Plan, click Continue from page 12. Privacy, Data Storage and Confidentiality of the new study application.

6

Page 12.1 Research Data Security Plan displays, with a link to the Research Data Security Plan.

2. To go to the Research Data Security Plan, click the RDS_Proxxxxxxxx link.

7

The Research Data Security Plan workspace displays.

3. To complete the Research Data Security Plan pages, click View/Edit Security Plan.

8

The first page of the Research Data Security Plan displays.

4. Enter the Research Data Security Plan information and Continue through all of the pages.

At any time, to exit the study pages to return later, click the Exit link at the top of the page and click Yes to confirm you want to save changes if applicable.

9

10

11

12

13

5. Click Finish to exit the Research Data Security Plan pages and return to the Research Data Security Plan workspace.

14

6. Click Check Data Security Plan for Errors to check for any errors.

When no errors are found, the confirmation page displays.

15

7. The Project Status changes to Ready for Protocol Submission.

Click OK to complete the error check and return to the Research Data Security Plan workspace.

8. Go to the study workspace, complete the new application pages, and Submit the new study application.

16

There is a link to the RDSP on the study workspace.

17

When the PI electronically signs the study, the Research Data Security Plan is submitted and its Project Status changes to Organization – Awaiting Screening.

18

How to Respond to Reviewer Requests

When changes are needed to the Research Data Security Plan, responding to requests for changes is a two-step process. First, you make the changes to the plan pages. Second, you must perform an activity to notify the reviewer that your changes are complete and ready for review.

The Research Data Security Plan review workflow is separate from the new study application workflow, but the process is the same as described in the Quick Reference Guide for Organization Review. The Research Data Security Plan shows on the tasklist with the name RDSP_Proxxxxxxxx.

1. Click the Name link to open the Research Data Security Plan.

19

The reviewer comment displays in the History.

2. To view and make changes to the security plan pages, click View / Edit Security Plan in the column at the left.

20

The first page of the Research Data Security Plan displays.

21

3. Enter changes to the Research Data Security Plan information and Continue through all of the pages, as applicable.

To exit the study pages and return to the Research Data Security Plan workspace, click the Exit link at the top of the page, and click Yes to confirm you want to save changes.

22

4. Click the Send Comment to Reviewer activity to return the Research Data Security Plan to the reviewer.

23

5. Enter comments as applicable and click OK.

24

The Research Data Security Plan returns to the Organization – In Review status, and removed from the Study Team tasklist.

25

How to Revise an Approved Research Data Security Plan

1. To revise a previously approved Research Data Security Plan, first open the study.

Then click the Research Data Security Plan link in the study header to view the Security Plan workspace.

26

2. Click Open Security Plan for Revision.

3. Click OK to confirm.

The Security Plan is opened for revision.

27

4. Click View/Edit Security Plan.

The first page of the Security Plan displays.

28

5. Update the Security Plan information, Save the changes, and Exit, as applicable.

The Security Plan workspace displays.

29

The History folder contains a log of the changes. To view the revised Security Plan, click View/Edit Security Plan or Printer Friendly Version.

6. Click Submit Revised Security Plan to route the revised Security Plan for review.

7. Click OK to confirm.

The revised Security Plan is routed to the Department/CRU Administrator for review.

30

For Reviewers

How to Complete Your Review

1. To view your Tasklist, click the My Home link in the top blue banner.

2. Click the link to the Research Data Security Plan under the “Name” column to open the plan.

31

New Research Data Security Plans and revisions to previously approved Security Plans can be assigned to you for review.

Changes to the Security Plan are logged in the History folder.

32

3. Click View Security Plan or Printer Friendly Version to view the new or revised Security Plan pages.

The first page of the Research Data Security Plan displays.

33

4. Click Continue to proceed through all of the pages.

At any time, if you want to exit the study pages to return later, click the Exit link at the top of the page.

34

5. Click Organization – Complete Review in the column at the left.

35

6. Select a Motion from the drop down box, enter comments and attach review documents as applicable, and click OK.

36

Your review displays in the History folder.

The status of the Research Data Security Plan returns to Review Complete, and the item is removed from the assigned reviewer’s tasklist.

37

How to Request Changes of the Study Team

1. Click the Request Changes as Organization Reviewer activity in the column at the left.

38

2. Type a comment, attach checklists as applicable, and click OK.

39

The request displays in the History folder.

The study team can make the requested changes and use the Send Comment to Reviewer activity to enter a response, send email notification, and return the Research Data Security Plan to your tasklist.

40

For Approvers and Administrators

The Research Data Security Plan review workflow is separate from the new study application workflow, but the process is the same as described in the Quick Reference Guide for Organization Review. The Research Data Security Plan shows on the tasklist with the name RDSP_Proxxxxxxxx.

41

New Research Data Security Plans and revisions to previously approved Security Plans are routed to the Department/CRU for review.

Changes to the Security Plan are logged in the History folder. Click View Security Plan or Printer Friendly Version to view the new or revised Security Plan pages.

42

How to Complete Your Review

You Take Ownership for Screening, Request Changes, Assign Reviewers and Issue the Final Motion as described in the Quick Reference Guide for Organization Review with the following differences:

Only people with the IT Reviewer role assignment are available as Reviewers There is only one Final Motion to Approve, so you should do that activity when you are ready to

approve the Research Data Security Plan for the organization.

Note: When the study team withdraws a protocol, the associated RDSP is not automatically withdrawn. If you would like an RDSP withdrawn, email a request to: eIRB@mc.duke.edu.

How to Maintain Personnel for Your Organization

Continue to maintain personnel for your organization as described in this section of the Quick Reference Guide for Organization Review.

43

Getting Help

Technical Support

eIRB HomeSee http://eIRB.mc.duke.edu for help logging in to the eIRB, User Guides, and Frequently Asked Questions (FAQ).

eIRB EmailEmail eIRB@mc.duke.edu to contact IRB IT staff for help using the eIRB.

DHTS Help DeskCall the DHTS Help Desk at 684-2243 for help with network connectivity, NetID and NetID password.

Research Data Security Plan Support

Information Security OfficeSee the Information Security Office (ISO) web page, under the Quick Link “Guidance” >Duke University School of Medicine/School of Nursing >Research Data Security Planhttps://www.iso.duke.edu/modules/iso_links/index.php?id=17

44