Core Committee Staff Step-by-Step Procedureseresinfo/errm/docs/Core_Staff_Overview.pdf · eResearch...

eResearch Core Committee Staff

Step-by-Step Procedures

Last updated: 12/04/06 1 of 112 v.1.5

Using eResearch Table of Contents

I. Overview ......................................................................................................................................................... 2 Approval and Expiration Dates ..................................................................................................................... 2

II. Automatic Notifications................................................................................................................................... 2 III. Logging into eResearch ................................................................................................................................ 3

Navigation ..................................................................................................................................................... 3 Signing Into eResearch and Authentication ............................................................................................ 3

Adding New User .......................................................................................................................................... 5 IV. Using the eResearch Home Workspace....................................................................................................... 7 V. Processing New Submissions – Assign an Owner........................................................................................ 8 VI. Reviewing Online Submissions .................................................................................................................. 11

Expedite Review ......................................................................................................................................... 11 Exempt Review ........................................................................................................................................... 20 Not Regulated ............................................................................................................................................. 26 Full Committee ............................................................................................................................................ 32 Adverse Event – Full Committee Review.................................................................................................... 41 Adverse Event – Single Member Review.................................................................................................... 52 Review Activities ......................................................................................................................................... 59

VII. Changes and Correspondence.................................................................................................................. 60 Requesting Changes from the Study Team................................................................................................ 60 Posting Correspondence............................................................................................................................. 62 Adding Comments....................................................................................................................................... 64

Uploading Information ...................................................................................................................................... 66 Viewing Submitted Changes....................................................................................................................... 67

VIII. Printing an Online Submission.................................................................................................................. 70 Recording Elements of Discussion ............................................................................................................. 74 Recording Committee Decision .................................................................................................................. 76

IX. Managing Meetings..................................................................................................................................... 78 Scheduling a Meeting.................................................................................................................................. 78 Editing Discussion Items............................................................................................................................. 80 Prepare Report of Exempt/Expedited Reviews .......................................................................................... 83 Add Meeting Minutes from Previous Meeting to Agenda............................................................................ 85 Preparing and Mailing Agendas.................................................................................................................. 87 Sending Out Special Notices (Optional Step)............................................................................................. 89 Updating Meeting Attendees....................................................................................................................... 91 Conclude Meeting ....................................................................................................................................... 93 Update Meeting History............................................................................................................................... 95 Approve Meeting Minutes ........................................................................................................................... 97

X. Validating Decisions..................................................................................................................................... 99 Preparing Letters (Optional Step) ............................................................................................................. 100 Approve..................................................................................................................................................... 101 Approve with Contingencies ..................................................................................................................... 102

Edit Contingencies ............................................................................................................................... 102 Send Approve with Contingencies Letter............................................................................................. 104 Defer to Reviewer ................................................................................................................................ 105 Enter Completion Date for Contingencies ........................................................................................... 106 Issue Approval Letter ........................................................................................................................... 107

Disapprove ................................................................................................................................................ 108 Action Deferred ......................................................................................................................................... 109 Tabled ....................................................................................................................................................... 110 Finalizing Consent Forms ......................................................................................................................... 111



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I. Overview This document provides a detailed description of the procedures Core Committee Staff members will use to manage applications for human subject research in eResearch.

Approval and Expiration Dates The following table details how approval and expiration dates are set in eResearch. Review Type System Action Approval Date Expiration Date Full Committee Record

Committee Decision

Date of Meeting Approval Date + Approval Period – 1 day

Expedited Submit Reviewer Checklist

Date reviewer submits review with a review determination of Approved or Approved with Contingencies

Approval Date + Approval Period – 1 day or Other Date specifically entered by the reviewer

Administrative or Expedited - Exempt

Submit Reviewer Checklist

Date reviewer submits review with a review determination of Exempt

No Expiration Date Set

Administrative or Expedited - Not Regulated

Submit Reviewer Checklist

Date reviewer submits review with a review determination of Not Regulated

No Expiration Date Set

Edit Approval Period

Specific Date entered by Core Staff

Specific Date entered by Core Staff

II. Automatic Notifications eResearch automatically notifies Study Teams of an upcoming expiration at 90, 60, and 30 days prior to expiration.



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III. Logging into eResearch

Navigation The eResearch application is accessed at http://eresearch.umich.edu.

Important Information

• For more information on how to obtain a uniqname and a UMICH Kerberos password, go to: www.itd.umich.edu/help/faq/uniqnames.

• For Study Team Staff and Reviewer activities, eResearch supports the following system configurations:

o Windows 2000 or Windows XP and Internet Explorer 6.0r

o Macintosh OSX and Safari

• For optimal viewing, the recommended screen resolution size is 1024 x 768 or higher.

Signing Into eResearch and Authentication

Browser Home Page 1. Type http://eresearch.umich.edu into the

Address field and press Enter.

eResearch Home Page

2. Click the Login link.

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UM Authentication Required Page 3. Click in the login field and type your

uniqname.

4. Tab to the password field and type your UMICH Kerberos password.

5. Click or press Enter.

eResearch Home Workspace 6. The eResearch application opens and

displays your Home Workspace.

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Adding New User Tip: The easiest way to add a new user is to have the person requesting access log into eResearch. If you need to add a new user, you will need the user’s uniqname, first and last name, and email address.

eResearch Home Workspace 1. Select the Study Team Member role.

2. Click New User.

New User Request 3. Select whether the new user is affiliated

with U-M.

• Select Yes if the user has a uniqname

4. Click Continue.

New User Request 5. Enter the new user’s contact information.

6. Click Finish.

Access Request Workspace 7. Click Add New User.

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Add New User Window 8. Click OK.

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IV. Using the eResearch Home Workspace

eResearch Home Workspace 1. Your Home Workspace displays all the

eResearch submissions associated with you, organized by status (Inbox, Unassigned, In Progress, Completed, and All Reviews).

• Submissions can be accessed by clicking the appropriate tab for each category.

• Submissions that require action appear under My Inbox.

Note: New submissions will not appear in the Inbox unless you are assigned as the owner and you are required to take some action.

2. Individuals with multiple roles in eResearch, such as Core Committee Staff and Study Team Member, can select the appropriate role under My Roles.

3. Click Inbox to display submissions that require action by you.

4. Click the navigational arrows to display next and previous pages within each tab.

5. Click My Home from any page in eResearch to return to your Home Workspace.

6. Click Logoff to exit eResearch.

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V. Processing New Submissions – Assign an Owner

eResearch Study Workspace 1. Verify Core Committee Staff is displayed

on the home workspace.

2. Click the Unassigned tab.

Note: All unassigned submissions will appear.

Unassigned Tab 3. All Unassigned submissions are now

displayed.

4. Click on the Submission ID to access the study.

Important Workspace Information!

• You must go to the Submission ID to open the study, not the Review Name.

• Clicking on the Submission ID takes you directly to the Submission Workspace.

• All Core Staff reviewing, assigning, approving, etc. is performed from the Submission ID area.

• Submission State displays the current state of the Submission.

• Staff Notes displays both the auto-generated and staff edited information about the submission.

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Assign Owner 5. Click Assign Owner.

Select Person 6. Click Select to assign the Primary Owner.

7. Type the first three letters of the last name and click Go.

8. Select the staff member.

9. Click OK.

Notes:

• Individuals are added to the Select Person list once they log into eResearch for the first time and have been given the role of IRB staff. If the staff member you are attempting to add does not appear in this list, ask the individual to log into eResearch or use the New User activity in the study workspace and then request access for that person.

• Secondary Core Staff Owner and Other Core Staff Owners can be added following the above procedure. However, every staff owner works within the same Reviewer Checklist.

10. Click OK on the Assign Owner screen.

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eResearch Study Workspace 11. Verify the name of the owner now assigned

to the study.

12. Click My Home to return to your Home Workspace.

eResearch Home Workspace 13. If you selected yourself as the owner, the

study now appears in your Inbox.

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VI. Reviewing Online Submissions Important Information

• Applications are submitted for review in eResearch in one of four ways:

o Expedite – The submission requires review by a selected committee member only. The committee is selected and a designated reviewer is assigned. The submission is not scheduled for a review meeting. (See page 11)

o Exempt – The Core Staff determines that the submission is exempt from review. An exempt reviewer is selected to review the submission and confirm the exempt decision. The submission is not scheduled for a review meeting. (See page 20)

o Not Regulated – The submission does not require IRB approval. A letter is prepared and sent to the study team, and the submission is stored in the Exempt & Not Regulated section of eResearch. (See page 26)

o Full Committee – The submission requires review by the full IRB committee. A committee is selected and primary and secondary reviewers are assigned. You can also assign additional reviewers as needed. The submission is scheduled for review at an IRB meeting. Meeting decisions are recorded in eResearch by the Core Staff. (See page 31)

Expedite Review

Core Committee Staff Review - Expedite 1. Verify the current role is Core Committee

Staff Review.

2. The following information is displayed:

• Submission Information – This area displays information such as the Study Team Member, Core Committee, Staff Owner, Committee Information and Required Ancillary Approvals.

• My Reviews – This section shows the submission name, reviewer role, status and recommendation.

• Tabs – This area displays Correspondence, Notes, IRB, All Issues, Documents, Change Tracking, and History tabs.

3. At My Reviews, click on Click here to edit review.

Note: This takes you directly into the Staff Review for the submission.

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Print Version of the Submission 4. If desired, click Print Version of the

Submission to open the submission.

5. The Printed Version of the Submission opens in a separate window.

Note: The submission can be moved around and resized within the eResearch window to allow for review of the submission and checklist simultaneously.

Reviewer Checklist The column headings in the checklist are as

follows:

6. Section identifies the section of the submission that needs to be reviewed.

Note: You can click on the section number to go directly to that section of the smartform.

7. Reviewer Checklist Item displays the question and sub-set question needed for review.

8. Click Condition Met if the condition in the Reviewer Checklist item has been met.

Note: At the end of the checklist, you can auto populate any responses in the Condition Met column that have not been completed. (See next section for details.)

9. Click Publish to Study Team to publish the identified issue to the study team.

Note: If this box is checked, all study team members can view the identified issue and corresponding comments once the review is submitted. If this box is not checked, only staff and committee members will have access to this data.

10. Comments can be added for reference at a later date.

Note: When a condition is not met, a comment is required and will be converted to an identified issue upon submission of the Reviewer Checklist.

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11. To be Reviewed by can be used if an issue needs to be reviewed by another reviewer. Use the drop down box to select the reviewer.

Checklist – General Issues & Reviewer Notes 12. Notes can be added to General Issues for

Study Team and/or Staff.

Note: These then become Identified Issues.

13. Reviewer Notes can be added and will only appear on the review form.

14. Click on Add to include Supporting Review Documents, if desired.

Adding Supporting Documents - Optional 15. Enter a title for the uploaded document.

Note: Entering a title is optional. If you do not enter a title, the filename becomes the title of the document.

16. Use the Browse button to locate the document on your computer.

17. Select the file to upload.

18. Click Open.

19. Click OK.

Review Recommendation 20. Choose the desired Reviewer

Recommendation.

21. Check the Check here… box if you would like to auto populate any Condition Met responses that were not completed. Checklist items with comments will be populated with No and items without comments will be populated with Yes.

22. Click Continue.

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Submit Review 23. When a condition is not met, the

associated comment will be converted to an Identified Issue upon submission of the review.

24. Check Click here if you are ready to submit this review.

25. Click Finish.

Note: You can edit and resubmit the checklist at any time until the determination for the submission is processed and the study team is notified.

Process Decision 1. Verify the current role is Core Committee

Staff Review.

2. Multiple functions can be performed from My Activities. See the My Activities section for detailed information.

Select Committee 3. Click Select Committee, if necessary.

Note: Only IRBMED and PRC need to assign the submission to a committee.

4. Click on the committee that will be responsible for reviewing the application.

5. Click OK.

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Expedite Submission 6. Verify the current role is Core Committee

Staff Review.

7. Click Expedite.

Select Expedited Staff Reviewer 8. Click Select to assign the primary

Reviewer.


10. Select the Committee member.

11. Click OK.

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Complete Expedited Form 12. Add Inbox Staff Notes, if applicable.

13. Choose Expedited Category, if desired.

14. Click OK.

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Validate Expedited Decision Note: Validate Expedited Decision can only

take place after the expedited review has been submitted by the expedited Reviewer.

1. Verify the current role is Validate Expedite Decision.

2. Click Record Expedited Decision.

Record Expedited Decision 3. Choose Review Determination.

4. For IRB only, choose Approval Period.

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Indicate Expedited Category

5. Verify Expedited Category, if needed.

6. If the reviewer has determined this submission is exempt, verify the Exemption Category.

7. Click OK.

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Approve Expedited Decision 1. Verify the current role is Validate

Expedited Decision.

2. Click on Approve.

3. Optional, select the Reviews to be published.

4. Choose the Approval Template from the drop-down menu.

5. Review the Approval Letter.

Tip: Verify that the correct committee, correct signature and correct approval date is displayed.

6. Click OK.

Finalize Documents 1. Verify the current role is Approved.

2. Click Finalize Documents.

3. Select the Consent Form documents and/or Recruitment materials to finalize.

4. Verify the dates and edit, if necessary.

5. Click OK to watermark the document(s) and move it to the Currently Approved Documents area under the Documents tab in the application workspace.

Submission Approval Complete 1. The Submission has been approved for

research.

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Exempt Review

Core Committee Staff Review – Exempt 1. Verify the current state is Core Committee

Staff Review.






Note: This takes you directly into the Staff Review for this submission.





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follows:

6. Section identifies the main section of the submission that needs to be reviewed.










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13. Reviewer Notes can be added and will only appear on this reviewers’ form.






18. Click Open.

19. Click OK.


Recommendation.


22. Click Continue.

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Exempt Determination 23. Check on the Exempt Category applicable

to the submission.

24. Click Finish.

Submit Review 25. Check Click here if you are ready to

submit this review.

26. Click Finish.

Note: You can edit and resubmit the checklist at any time until the determination for the submission is processed and the study team is notified. You can find the review under the “In Progress” tab on your Core Committee Staff Workspace. 25

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Core Committee Staff Review 1. Verify the current role is Core Committee

Staff Review.


Exempt Determination 3. Click Exempt Determination.

4. View the Approval Letter.

5. Click OK.

Exempt Approval - Initial 1. Verify the current role is Exempt Approval

– Initial.

Note: The submission is now approved.

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Finalize Documents 2. Click Finalize Documents.

3. Select the documents to finalize.



Approval Complete 1. The submission has been approved and

the corresponding documents watermarked.

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Not Regulated

Core Committee Staff Review – Not Regulated 1. Verify the current role is Core Committee

Staff Review.





3. At My Reviews, click on Click here to edit review to begin the submission review.

Note: This takes you directly into the Staff Review Checklist for this submission.





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follows:

6. Section identifies the main section of the submission that needs to be reviewed.










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13. Reviewer Notes can be added and will only appear on the reviewers’ workspace.






18. Click Open.

19. Click OK.


Recommendation.


22. Click Continue.

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Not Regulated Determination 23. Choose the correct Not Regulated

Determination.

Note: Multiple determinations may apply to the study. Select as many that apply.

24. Click Continue.

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submit this review.

Note: If you are not ready to submit the review, click on Save to save your work and then Exit.

26. Click Finish.

Note: You can edit and resubmit the checklist at any time until the determination for the submission is processed and the study team is notified. You can find the review under the “In Progress” tab on your Committee Member Workspace.


Staff Review.

2. Multiple functions can be performed from My Activities. See the My Activities section for detailed information

Not Regulated Determination 3. Click Not Regulated Determination.

4. Review the approval letter.

5. Click OK.

Note: If the submission needs to be reviewed, follow expedite or full committee step-by-step instructions.

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Not Regulated 6. Verify the current role is Not Regulated.

7. Click My Home to go to the home workspace.

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Full Committee

Core Committee Staff Review – Full Committee 1. Verify the current role is Core Committee

Staff Review.

Note: The following information is displayed:





Note: This takes you directly into the Staff Review for the submission.





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follows:











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12. Reviewer Notes can be added and will only appear on the review form.






17. Click Open.

18. Click OK.


Recommendation.


21. Click Continue.

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Submit Review 22. When a condition is not met, the

associated comment will be converted to an Identified Issue upon submission of the review.

23. Check Click here if you are ready to submit this review.

24. Click Finish.



Staff Review.


Select Committee 3. Click Select Committee, if necessary.

Note: Only IRBMED and PRC need to assign the submission to a committee.

4. Click on the committee that will be responsible for reviewing the application.

5. Click OK.

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Adding to the Agenda 6. Verify the current role is Core Committee

Staff Review.

7. Click Full Committee.

Assign to Full Committee 8. Choose Agenda Item Type

• New Study

• Deferred Study

• Deferred – Pending Clarification

• Continuing Issues

• Amendment

• Adverse Event / ORIO

• Reactivation Request

• Scheduled Continuing Review

• Final Reports

• HIPPA Requirement

• Discussion Items

• Resubmission

• Previous Meeting

• IBC Registration

• Unanticipated Problem Review

9. Add Inbox Staff Notes, if applicable.

10. Use Reviewer Selection to select Primary, Secondary, Regulatory, Scientific, and Other Reviewers, if applicable.

Note: If desired, Staff can assign Reviewers and not assign a meeting, or assign a meeting and not assign Reviewers.

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11. Choose the Meeting Date.

12. Add any Conflicted Committee Members.

13. Click OK.

Full Committee Review 1. Verify the current role is Full Committee.

2. The following new actions can be performed from My Activities:

• Full Committee: Used to add, delete, and/or modify agenda item type, inbox staff notes, reviewers, meeting date and conflicted committee members.

• Record Committee Decision: Used to record the results of the meeting (does not send the PI any correspondence).

• Record Elements of Discussion: Used to record both the draft and final elements of discussion and to add any related documents.

• Remove from Agenda: Removes the submission from the meeting agenda it is currently assigned to.

Note: The Reviewer Checklist will remain with the currently assigned Reviewer(s) unless you delete the Reviewer in the Full Committee or Expedite activity.

3. Click Record Elements of Discussion.

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Record Elements of Discussion 4. Enter Draft Elements of Discussion.

5. Optional - enter Final Elements of Discussion.

6. Add Related Documents, if applicable.

7. Click OK.

Record Committee Decision 1. Verify the current role is Full Committee.

2. Click Record Committee Decision.

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Record Committee Decision 3. Enter Time of Vote.

4. Choose Motion.

• Approved

• Approved with Contingencies

• Action Deferred Pending Study Team

• Exempt Determination

• Action Deferred Pending Core Committee

• Not Regulated Determination

• Disapproved

• Disapproved Final

• Tabled

5. If applicable, select the Committee Member for Motion and Motion Seconded.

6. Enter Total Votes, Yes Votes, Abstained Votes, Abstained Members and No Votes.

7. Add Known Conflicted Committee Members and Members Out of Room, if applicable.

8. IRB Only: Select the length in months of the Approval Period for the study.

9. Click OK.

Validate Committee Decision 1. Verify the current role is Validate

Committee Decision.

2. Click Approve.

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Approval Letter 3. If desired, select the Reviews to be

published.

4. Verify Approval Letter contents.


5. Click OK.

Post Approval - Finalize Documents 1. Verify the current role is Approved.

2. Click Finalize Documents.

3. Select the Consent Form documents and/or Recruitment materials to finalize.



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Adverse Event – Full Committee Review





3. Click on the Adverse Event Submission ID to access the AE/ORIO.




• All Core Staff reviewing, assigning, approving, etc. is performed from the Submission Workspace.


• Staff Notes displays the last action that was performed on the submission.

Assign Owner 1. Verify the Current State is Core

Committee Staff Review.

2. Click Assign Owner.

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6. Click OK.

Notes:


• Secondary Core Staff Owner and Other Core Staff Owners can be added following the above procedure. However, every owner works within the same Reviewer Checklist.


Core Committee Staff Review 1. Verify the current state is Core Committee

Staff Review.



• My Reviews – This section shows the submission name, reviewer role, state and recommendation.



Note: This takes you directly into the Revision Checklist.

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5. The Submission opens in a separate window.



follows:







Note: If this button is checked, all study team members can view the identified issue and corresponding comments once the review is submitted. If it is not checked, only committee members will have access to this data.


Note: When a condition is not met, a comment is required and will be converted to an identified issue upon submission.

6. To be Reviewed by can be used if an issue needs to be reviewed by another

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reviewer. Use the drop down box to select the reviewer.



8. Reviewer Notes can be added and will only appear on the staff reviewers’ workspace.



Note: Entering a title is optional. If you do not enter a title, the title becomes the filename of the document.



13. Click Open.

14. Click OK.


Recommendation.


17. Click Continue.

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submit this review.

19. Click Finish.


Core Committee Staff Review 1. Verify the Current state is Core Committee

Staff Review.

2. The following actions can be performed from My Activities:

• Assign Owner – Changes the owner of the submission.

• Changes Request by Core Committee Staff: Notifies the PI that changes to the submission are required before they can be approved.

• Single Member Review: Assigns submission to a single committee member for review.

• Full Committee: Assigns submission to a full committee review.

• Select Committee: Selects the committee that will be responsible for reviewing the submission.

• Edit Identified Issues: Used to add, change, or delete outstanding Identified Issues for this submission

• Edit Agenda Information: Used to add staff notes to the agenda and edit conflict of interest information.

• Post Correspondence: Used to post comments and documents to the study workspace.

• For Reviewers and IRB Office:

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Used to post comments and documents to the study workspace where they can be viewed and/or downloaded by all Core Office Staff, Committee members and Reviewers (comments are not viewable by study team members).

• For IRB Office Staff Only: Used to post comments and documents to the study workspace where they can be viewed and/or downloaded by IRB Office Staff only (not viewable by Study Staff or Committee Members).

Select Committee 3. Click Select Committee.

Note: Only IRBMED need to assign the submission to a committee.

4. Select the committee that would be responsible for reviewing this adverse event.

5. Click OK.

Adding to the Agenda 1. Verify the current state is Core Committee

Staff Review.

2. Click Full Committee.

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Assign to Full Committee 3. Choose Adverse Event / ORIO as

Agenda Item Type





7. Click OK.

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Full Committee Review 1. Verify the current state is Full Committee.

2. The following new actions can be performed from My Activities:

• Full Committee: Used to add, delete, and/or modify agenda item type, inbox staff notes, reviewers, meeting date and conflicted committee members.

• Record Committee Decision: Used to record the results of the meeting (does not send the PI any correspondence).

• Record Elements of Discussion: Used to record both the draft and final elements of discussion and to add any related documents.

• Remove from Agenda: Removes the submission from the meeting agenda it is currently assigned to.

Note: The Reviewer Checklist will remain with the currently assigned Reviewer(s) unless you delete the Reviewer in the Full Committee or Expedite activity.

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Record Elements of Discussion 4. Enter Draft Elements of Discussion.

5. Optional - enter Final Elements of Discussion.

6. Add Related Documents, if applicable.

7. Click OK.

Record Committee Decision 1. Verify the current state is Full Committee.


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Record Committee Decision 3. Enter Time of Vote.

4. Choose Motion.

• Approved




• Action Deferred Pending Core Committee


• Disapproved


• Tabled

5. If applicable, select the Committee Member for Motion and Motion Seconded.

6. Enter Total Votes, Yes Votes, Abstained Votes, Abstained Members and No Votes.

7. Add Known Conflicted Committee Members and Members Out of Room, if applicable.

8. Answer if the board considered this submission for an unanticipated problem.

9. Click OK.

Validate Committee Decision 1. Verify the current role is Validate

Committee Decision.

2. Click Approve.

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Approval Letter 3. If desired, select the Reviews to be

published.

4. Verify Approval Letter contents.


5. Click OK.

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Adverse Event – Single Member Review





3. Click on the Adverse Event Submission ID to access the AE/ORIO.




• All Core Staff reviewing, assigning, approving, etc. is performed from the Submission Workspace.


• Staff Notes displays the last action that was performed on the submission.

Assign Owner 4. Verify the Current State is Core


5. Click Assign Owner.

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9. Click OK.

Notes:


• Secondary Core Staff Owner and Other Core Staff Owners can be added following the above procedure. However, every owner works within the same Reviewer Checklist.


Core Committee Staff Review 1. Verify the current state is Core Committee

Staff Review.



• My Reviews – This section shows the submission name, reviewer role, state and recommendation.



Note: This takes you directly into the Revision Checklist.

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5. The Submission opens in a separate window.



follows:







Note: If this button is checked, all study team members can view the identified issue and corresponding comments once the review is submitted. If it is not checked, only committee members will have access to this data.


Note: When a condition is not met, a comment is required and will be converted to an identified issue upon submission.

6. To be Reviewed by can be used if an issue needs to be reviewed by another

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reviewer. Use the drop down box to select the reviewer.



8. Reviewer Notes can be added and will only appear on the staff reviewers’ workspace.



Note: Entering a title is optional. If you do not enter a title, the title becomes the filename of the document.



13. Click Open.

14. Click OK.


Recommendation.


17. Click Continue.

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submit this review.

19. Click Finish.

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Select Single Member Review 1. Verify that the current state is Core


2. Click on Single Member Review

3. Select to assign the Primary Reviewer

4. Click OK.

Record Single Member Review Decision 1. Verify that the current state is Validate

Single Member Review Decision.

2. Click Record Single Member Review Decision.

Single Member Review Motion 3. Choose the appropriate Single Member

Review Motion.

4. Click OK.

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Approve Single Member Review Decision 1. Verify that the current state is Validate

Single Member Review Decision.

2. Click on Approve

Approve 3. Optional, select the Reviews to be

published.

4. Choose the Approval Template.

5. Review the Approval Letter.

Tip: Verify that the correct committee, correct signature and correct approval date are displayed

6. Click OK.

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Review Activities The following actions can be performed from My Activities on the Review screen:

• Assign Owner – Changes the owner of the submission.

• Changes Request by Core Committee Staff: Notifies the PI that changes to the application are required before they can be approved.

• Select Committee: Selects the committee that will be responsible for reviewing the application.

Note: This only applies to IRB Med and PRC.

• Edit Identified Issues: Used to add, change, and delete the outstanding issues for the submission.

• Prepare Letter: Used to prepare the submission outcome letter.

Note: This function is used to prepare any of the letters.

• Edit Agenda Information: Used to add staff notes to the agenda and edit conflict of interest information.

• Manage Documents: Used to add and/or delete documents that appear under the documents tab in the application workspace.

• Send Back to Ancillary Review: Moves the application back to Ancillary Committee Review.

• Correct Required Core Committees: Used to send the application to a different IRB.

• Post Correspondence: Used to post comments and documents to the study workspace.

• For Reviewers and IRB/PRC/GCRC Office: Used to post comments and documents to the study workspace where they can be viewed and/or downloaded by all Core Office Staff, Committee members and Reviewers (comments are not viewable by study team members).

• For IRB/PRC/GCRC Office Staff Only: Used to post comments and documents to the study workspace where they can be viewed and/or downloaded by IRB/PRC/GCRC Office Staff only (not viewable by Study Staff or Committee Members).



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VII. Changes and Correspondence Important Information

• eResearch provides multiple methods for Core Staff to communicate with study teams, including requesting changes to the submission, sending correspondence, and adding comments directly to the submission. All change requests, correspondence, and comments are tracked in the eResearch system for future reference.

• When requesting changes to a submission, use the Changes Requested by Core Committee Staff activity. This activity changes the state of the submission, transferring responsibility for the next action to be taken to the study team.

• Changes may also be initiated by Reviewers. If reviewers require additional information or changes from the study staff, they have the option to Request Clarification/Change. Core Staff then request changes from the study team using the Changes Requested by Core Committee Staff activity.

• The Post Correspondence activity is used to communicate with all the individuals related to the study but does not change the state of the study. Note that all communications created with the Post Correspondence activity are visible to all eResearch users with access to the study.

• Core staff members can add comments viewable by Core Staff only, or by Core Staff and Reviewers only using the Add Comments activities. These activities allow comments to be added to the submission with no change in the state.

Requesting Changes from the Study Team

eResearch Study Workspace 1. Select Changes Requested by Core

Committee Staff.

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Change Request Window 2. Enter your Comments to the study team in

the box.

Note: If you created Notes for the study team in the application, indicate that these Notes can be found in the Notes tab.

3. Use the Add button to attach documents, if needed.

4. Click OK.

eResearch Study Workspace 5. The state of the application is changed and

an activity is added to the Correspondence tab indicating the request for changes from the study team.

Note: All Draft Change requests are published to the study team and require a response.

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Posting Correspondence Important Information

• The Post Correspondence activity can be used by anyone with access to the study to communicate with study team members and Core Staff. It does not change the state of the study.

• Note: All communication created through the Post Correspondence activity is visible to all eResearch users with access to the study.

eResearch Study Workspace 1. Click Post Correspondence.

Post Correspondence Window

2. Enter your Comments to the study team and/or Core Staff.

3. Add documents, if desired.

4. Select the desired recipients of the email notification.

5. Click OK.

Note: The team member and core committee will receive an email notification of this correspondence.

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eResearch Study Workspace 6. An activity appears under the

Correspondence tab indicating that a correspondence was posted.

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Adding Comments Important Information

• The Add Comments activities allow comments to be added to the submission with no change in the state. Core staff members can add comments that are viewed by Core Staff only, or by Core Staff and Reviewers only.

eResearch Study Workspace 1. Click For Reviewers and IRB Office or

For IRB Office Staff Only to add a comment.

Comment Window 2. Enter your Comments.

3. Use the Add button to attach documents, if needed.

4. If needed, select who should receive email notification of the correspondence.

5. Click OK.

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eResearch Study Workspace 6. Comments for reviewers and staff display

under the IRB tab under For Reviewers and IRB Office.

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Uploading Information Important Information

• Supporting documents can be uploaded to certain sections of the eResearch study application.

• An button appears in these sections.

eResearch Study Application 1. Click the Add button to attach supporting

documents to the study.

Adding Supporting Documents

2. Enter a title for the document you are uploading or leave it blank.




5. Click Open.

6. Click OK.

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Viewing Submitted Changes Important Information

• When the study team completes the requested changes to the application and submits them for your review, you receive an email notification with a link to the application in eResearch.

Core Committee Staff Home Page

1. Once the study team submits the requested contingencies, the submission will display in the Core Staff owner’s Inbox.

2. Click on the Submission ID in the Inbox.

Note: The state of the staff review displays Review Study Team Changes.

Core Committee Staff Contingency Review 3. Click View Study to determine if the

contingencies have been met.

Note: The Change Tracking tab displays changes made to the submission.

4. If necessary, click Refer to Designated Reviewer.

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Refer to Designated Reviewer 5. Check the checkbox next to the Reviewer

needed to review the contingencies.

6. Select Other Reviewers to review the contingencies, if applicable.

7. Outstanding Identified Issues will also go to the assigned reviewer if they are selected. If the issue is assigned to the Primary Reviewer and you assign a Secondary Reviewer, they will not see the Outstanding Identified Issues.

8. Enter Inbox Staff Notes, if desired.

9. Click OK.

Notes:

• This function sends the review back to the Reviewer for review of the contingencies.

• The Submission will remain in your Inbox until you record the contingency decision.

Change Log Activity Details Page 10. Click the Change Tracking tab to review

the changes made to the submission.

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Activity Detail 11. The Activity Details displays the author,

activity date, etc. and all property and documents / tasks / notification changes.

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VIII. Printing an Online Submission Important Information

• You can print eResearch study applications from the Study Workspace or from within the application.

• The print version of the application includes only the required application sections. Detail information is printed at the end of the document.

eResearch Home Workspace 1. Click on the Submission ID to access the

study.

eResearch Study Workspace 2. Click Printer-Friendly Version.

Note: You can also open the study application and click the Print button to print specific sections of the submission.

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Print Window 3. Click Print.

Print Dialog Box

4. Click Print to print the application.

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Changing the Meeting for Review of Submission eResearch Study Workspace

1. If you need to change the meeting in which this submission will be reviewed, click Remove from Agenda.

Remove from Agenda Window 2. Click OK.

eResearch Study Workspace 3. Click Full Committee to select another

meeting.

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Add to Agenda Window 4. Select the Agenda Item Type from the

drop-down menu.





8. Click OK.

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Recording Elements of Discussion Important Information

During the committee meeting, you record the elements of discussion in eResearch. You can access all the studies for the meeting from the Printable Agenda.

Meeting Printable Agenda 1. From the Meetings Printable Agenda, click

the name of the study to open the Study Workspace.

eResearch Study Workspace 2. From the Study Workspace, click Record

Elements of Discussion.

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Record Elements of Discussion Window 3. Record ongoing discussion in the Draft

Elements of Discussion area.

4. Cut and paste the appropriate discussion items into Final Elements of Discussion.

Note: Discussion items that are entered here appear in the minutes for the meeting.

5. Add related documents, if needed.

6. Click OK.

eResearch Study Workspace 7. Click Record Elements of Discussion

again to edit the elements of discussion for this study prior to validating the committee decision.

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Recording Committee Decision Important Information

Once the submission is reviewed at the meeting, Core Staff record the decision in eResearch. The decision may include:

• Approved





• Disapproved


• Tabled

eResearch Home Workspace 1. Click the name of the submission to display

the study workspace.

eResearch Study Workspace 2. Click Record Committee Decision.

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Record Committee Decision Window 3. Select the Time of Vote.

4. Select the motion recorded in the meeting from the drop-down menu.

5. Record the events of the vote in the fields provided.

6. Choose the Approval Period, if applicable.

Note: IRB only.

7. Click OK.

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IX. Managing Meetings Important Information

Managing meetings involves the following steps:

• Scheduling a Meeting – (see page 78)

• Use Full Committee activity to add submissions to the meeting agenda – (see page 41)

• Editing Discussion Items – (see page 80)

• Prepare Report of Exempt/Expedited Reviews – (see page 83)

• Add Meeting Minutes from Previous Meeting to Agenda – (see page 85)

o Note: If necessary, you can modify minutes from a previous meeting using Update Meeting History in the Study Workspace (Optional Step). – (see page 95)

• Preparing and Mailing Agendas – (see page 87)

o Note: You can also notify all committee members using Sending Out Special Notices (Optional Step). – (see page 89)

• Updating Meeting Attendees – (see page 91)

• Conclude Meeting – (see page 93)

• Approve Meeting Minutes – (see page 97)

Scheduling a Meeting

eResearch Home Workspace 1. From your Home Workspace, click the

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eResearch Committee Workspace

2. Click New Meeting.

New Meeting Window 3. Enter the Name, Meeting Date, Location,

and Start Time of the meeting.

4. Enter comments in the Notes section, if necessary.

5. Click OK.

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Editing Discussion Items



eResearch Committee Workspace 2. Click the name of the upcoming meeting

with the agenda you wish to edit.

eResearch Meeting Workspace 3. Click Edit Discussion Items.

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Edit Discussion Items Window 4. Click Add.

Edit Discussion Items Window 5. Select the Type of discussion item.

6. Enter the Discussion Item Title.

7. Optionally, add a description, upload any supporting documents, or add any meeting notes.

8. Click OK.

Edit Discussion Items Window 9. The item is added to the Discussion Items.

10. Click OK.

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eResearch Meeting Workspace 11. The discussion item is added to the

meeting.

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Prepare Report of Exempt/Expedited Reviews



eResearch Committee Workspace 2. Click the name of the upcoming meeting.

eResearch Meeting Workspace 3. Click Configure Review Reports.

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Configure Review Reports Window 4. Select the type of reviews you want to

include in the report.

5. Enter the dates for the Beginning and Ending Dates of Approval Period to be included in the report.

6. Click OK.

eResearch Meeting Workspace 7. Click View Expedited/Exempt Reviews to

open the report.

Note: Use the Edit Discussion Items activity to add this item to the agenda.

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Add Meeting Minutes from Previous Meeting to Agenda



eResearch Committee Workspace 2. Click the name of the upcoming meeting in

which the minutes will be reviewed.

eResearch Meeting Workspace 3. Click Add Previous Meeting Minutes to

Agenda.

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Add Previous Meeting Minutes to Agenda Window 4. Click the radio button next to the previous

meeting with minutes to be reviewed in the upcoming meeting.

Note: Previous meetings must be in the state of Meeting Concluded – Minutes Not Approved to appear on this window. (See Conclude Meeting on page 82 for more information.) You can select minutes from more than one meeting.

5. Click OK.

Note: This activity adds a link to the previous meeting workspace to the agenda for the upcoming meeting. Click the link on the agenda to open the meeting workspace.

eResearch Meeting Workspace

6. Click View Printable Meeting Minutes to view the minutes.

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Preparing and Mailing Agendas




with the agenda you wish to send.

eResearch Meeting Workspace 3. Click View Agenda by Submission Type

to review a copy of the agenda.

Note: You can also click View Agenda by Reviewer to sort the Agenda by Reviewer.

• If you want to edit discussion items, see “Editing Discussion Items” on page 80.

4. Click Mail Out Agenda.

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Mail Out Agenda Window 5. Click OK.

Note: The agenda will be sent to IRB staff and Committee Members.

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Sending Out Special Notices (Optional Step)




related to the message you wish to send.

eResearch Meeting Workspace 3. Click Send Special Notice.

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Send Special Notice Window 4. Enter the Special Notice.

5. Click OK.

• The Special Notice is sent to all Committee Members.

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Updating Meeting Attendees


related to the attendees you need to update.

2. Click Edit Confirmed Attendees.

Edit Confirmed Attendees Window

3. To add attendees as confirmed or declined, click Add in the appropriate section. Continue to Step 5.

4. To remove attendees as confirmed or declined, select the person and then click Remove in the appropriate section.

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Select Person Window

5. To continuing adding a person, select the person from the list.

6. Click OK.

Edit Confirmed Attendees Window

7. Click OK.

eResearch Meeting Workspace 8. Attendees for the meeting are updated.

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Conclude Meeting




with the agenda you wish to send.

eResearch Meeting Workspace 3. Click Meeting Concluded.

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Meeting Concluded Window 4. Click OK.

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Update Meeting History


name of the Submission to be updated.

eResearch Study Workspace 2. Click Update Meeting History.

Update Meeting History Window 3. Click [Edit] next to the meeting to be

updated.

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Update Meeting History Window 4. Update the Time of Vote, if necessary.

5. Update the Abstained Votes and Abstained Members, if necessary.

6. Update the Yes Votes and No Votes, if necessary.

7. Update the Meeting Notes and Final Meeting Notes, if necessary.

8. Click OK.

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Approve Meeting Minutes



eResearch Committee Workspace 2. Click the name of the past meeting with

minutes to be approved.

eResearch Meeting Workspace


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Record Committee Decision Window 4. Enter the Start Time of Discussion

5. Select the Motion from the drop-down menu.

6. Enter Votes and Elements of Discussion.

7. Click OK.

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X. Validating Decisions Important Information

Core Staff members are responsible for processing the decisions of the reviewers on each eResearch submission. This is done through a decision validation.

• Validate Decision – A validation activity is provided for each decision type, which changes the state of the submission to reflect the decision. Some decisions send a letter to the study team. The possible decision types include:

o Approve – The Approval letter is sent to the study team. It includes the approval date and the expiration date. (See page 101)

o Approve with Contingencies – The Approved with Contingencies letter is sent to the study team. This letter contains the contingencies that must be completed before the study team can begin their research. (See page 102)

o Disapprove – The Disapproved letter is sent to the study team, informing them that the IRB has not approved the study. (See page 108)

o Action Deferred – No letter is sent to the study team. (See page 109)

o Table – No letter is sent to the study team. (See page 110)

o You can prepare the letter to be sent to the study before you complete the Validate Decision activity. This letter can be saved for use during the Validate Decision activity. See page 100 for more information.



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Preparing Letters (Optional Step) Important Information

Letter templates are provided in eResearch for communicating various decisions to the study team. These templates can be edited during the Validate Decision step. If extensive edits to the letter template are required, the Core Staff may use the Prepare Letter step to complete the edits prior to validating the decision.

eResearch Study Workspace

1. From the Study Workspace, click Prepare Letter.

Prepare Letter Window 2. Select the appropriate Approval Template

from the drop-down menu.

3. Click the down arrow to open the template editor toolbar.

4. Edit the letter.

5. Click OK.

Note: This action does not send the letter to the study team.

Note: If you created a letter using the Prepare Letter step, select Saved_Application from the Approval Template drop-down menu to access the prepared letter.

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Approve

eResearch Study Workspace 1. Click Approve.

Approve Window 2. Select the appropriate letter template from

the Approval Template drop-down menu.


3. Edit the letter, if necessary.

4. Click OK.

Note: This action sends the letter to the study team and changes the state of the submission to Approved.

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Approve with Contingencies Important Information

In the event a submission is approved with contingencies, extra steps are required to complete the approval process. The basic steps to approve a study that has contingencies are:

1. Edit the contingencies for the submission. (See page 102.)

2. Issue an Approve with Contingencies decision, which sends a letter to the study team detailing the contingencies that must be met before the research can begin. (See page 104.)

3. When the study team submits the required contingencies, defer the study to the designated reviewer to review the changes. (See page 105.)

4. If the contingencies have been met, use the Edit Contingencies activity to enter a completion date for the contingencies. (See page 106.)

5. Issue an Approval letter to the study team. (See page 107.)

Edit Contingencies

eResearch Study Workspace 1. Select Edit Contingencies.

Edit Contingencies Window 2. Click the Add button to create a

contingency for this submission.

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Edit Contingencies Edit Window 3. Select the type of contingency from the

Classification drop-down menu.

4. Enter a description of the contingency in the field provided.

5. Enter the date the contingency was created in the field provided.

6. If applicable, select the checkbox to indicate that the contingency needs to be verified by the Reviewer.

7. Click OK.

Edit Contingencies Window 8. The new contingency now displays in the

Contingency Window.

9. Click OK.

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Send Approve with Contingencies Letter

eResearch Study Workspace 1. Click Approve with Contingencies.

Approve with Contingencies Window 2. Select the appropriate letter template from




4. Click OK.

Note: This action sends the letter to the study team and changes the state of the submission to Contingencies Pending.

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Defer to Reviewer

eResearch Home Workspace 1. Once the study team submits the

requested contingencies, the submission will display in the Core Staff owner’s Inbox.

eResearch Study Workspace 2. Click View Study to determine if the

contingencies have been met.

3. If necessary, click Defer to Designated Reviewer.

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Enter Completion Date for Contingencies

eResearch Study Workspace 1. Select Edit Contingencies.

Edit Contingencies Window 2. Click the Edit link to update each

contingency.

Edit Contingencies Edit Window 3. Enter the date the contingency was

completed in the field provided.

4. Click OK.

Edit Contingencies Window 5. Click OK.

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Issue Approval Letter

eResearch Study Workspace 1. Click Approve.

Approve Window 2. Select the appropriate letter template from




4. Click OK.

Note: This action sends the letter to the study team and changes the state of the submission to Approve.

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Disapprove

eResearch Study Workspace 1. Click Disapprove.

Disapprove Window 2. Select the appropriate letter template from




4. Click OK.

Note: This action sends the letter to the study team and changes the state of the submission to Disapproved.

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Action Deferred

eResearch Study Workspace 1. Click Action Deferred.

Action Deferred Window 2. Click OK.

• The study returns to the Core Committee Staff Review state.

• See page 60 for more information on requesting changes from the study team.

• Once changes have been submitted, you must reassign the study to a new meeting for review.

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Tabled

Approve Window 1. Click Table.

Approve Window

2. Click OK.

• The study is tabled for the current meeting. You will need to select a new meeting where the study can be reviewed.

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Finalizing Consent Forms Important

When the study is approved, Core Staff finalize the consent forms for the study. Finalizing the consent forms moves the documents into the Finalized Documents area and, if the documents were composed with the correct templates, watermarks the documents with the IRB Name, Study Number, Approval Date, and Expiration Date. Documents provided as Microsoft Word documents are also converted to PDF.

eResearch Study Workspace 1. Click Finalize Consent Forms.

Action Deferred Window 2. Enter the Watermark Approval Date.

3. Select the documents to be finalized by checking the box next to each document.

4. If you are replacing previously-approved documents with the documents selected in the step 3, select the documents to be replaced.

5. Click OK.

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Study Workspace 6. Finalized documents are moved to the

Currently Approved Documents section on the Documents tab.

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