Module 5: Managing Meetings

Transcription

1 Table of Contents Module 5: Managing Meetings Module 5 Objective: Covers how to manage meetings for human subject research in eresearch. Refer to the table of contents below for the topics covered in Module 5. Table of Contents Scheduling a Meeting... 2 Changing the Meeting for Review of Submission... 3 Editing Discussion Items... 5 Prepare Report of Exempt/Expedited Reviews... 7 Add Meeting Minutes from Previous Meeting to Agenda Preparing and Mailing Agendas Sending Out Special Notices (Optional Step) Updating Meeting Attendees Conclude Meeting Recording Elements of Discussion Record Committee Decision Update Meeting History Approve Meeting Minutes Last updated: 9/30/10 1 of 29 v.2.1

2 Scheduling a Meeting Scheduling a Meeting eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click. 2 3 New Meeting Window Enter the Name, Meeting Date, Location, and Start Time of the meeting. 4. Enter comments in the Notes section, if necessary. 5. Click OK. Note: When creating multiple meetings (e.g., meetings for an entire year), always create the meetings in chronological order because meeting are sorted by the date they were created. Last updated: 9/30/10 2 of 29 v.2.1

3 Changing the Meeting for Review of Submission Important Information Changing the Meeting for Review of Submission Do not simply change the meeting date in the Full Committee activity to change a meeting. Follow the steps below to remove the submission from the meeting agenda first before change the meeting date. eresearch Study Workspace 1. If you need to change the meeting in which the submission will be reviewed, click Remove from Agenda. 1 Remove from Agenda Window 2. Click OK. 2 eresearch Study Workspace 3. Click Full Committee to select another meeting. 3 Last updated: 9/30/10 3 of 29 v.2.1

4 Changing the Meeting for Review of Submission Select the Agenda Item Type. Options include: New Study Deferred Study Deferred Pending Clarification Continuing Issues Amendment Adverse Event / ORIO Note: selected for adverse events Reactivation Request Scheduled Continuing Review Final Reports HIPPA Requirement Discussion Items Resubmission Previous Meeting IBC Registration Unanticipated Problem Review Add Inbox Staff Notes, if applicable. 6. Use Reviewers 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. 7. Choose the Meeting Date. 8. Enter Comments for Reviewers, if applicable. 9. If you are from IRB, select Review Study Team Changes if the study was previously deferred. Note: This will make the review appear in the committee members inbox. 10. Click OK to submit the review to the full committee. Last updated: 9/30/10 4 of 29 v.2.1

5 Editing Discussion Items Editing Discussion Items eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting with the agenda you wish to edit. 2 eresearch Meeting Workspace 3. Click Edit Discussion Items. 3 Last updated: 9/30/10 5 of 29 v.2.1

6 Editing Discussion Items Edit Discussion Items Window 4. Click Add. 4 Edit Discussion Items Window 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. 8 Edit Discussion Items Window 9. The item is added to the Discussion Items. 10. Click OK Last updated: 9/30/10 6 of 29 v.2.1

7 Editing Discussion Items eresearch Meeting Workspace 11. Verify that the added discussion item appears under the Agenda Discussion Items for the meeting on the Agenda tab. 11 Last updated: 9/30/10 7 of 29 v.2.1

8 Prepare Report of Exempt/Expedited Reviews Prepare Report of Exempt/Expedited Reviews eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting. 2 eresearch Meeting Workspace 3. Click Configure Review Reports. 3 Last updated: 9/30/10 8 of 29 v.2.1

9 Prepare Report of Exempt/Expedited Reviews Configure Review Reports Window 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. 6 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. 7 Last updated: 9/30/10 9 of 29 v.2.1

10 Add Meeting Minutes from Previous Meeting to Agenda Add Meeting Minutes from Previous Meeting to Agenda eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting in which the minutes will be reviewed. 2 eresearch Meeting Workspace 3. Click Add-Remove Previous Meeting Minutes to Agenda. 3 Last updated: 9/30/10 10 of 29 v.2.1

11 Add Meeting Minutes from Previous Meeting to Agenda Add Previous Meeting Minutes to Agenda Window 4 5 eresearch Meeting Workspace 7 4. If you do not wish to include any meeting minutes that appear, click remove the file from the list. Note: Previous meetings must be in the state of Meeting Concluded Minutes Not Approved to appear on this window or click to add a new file. (See the Conclude Meeting procedure 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. 6. Verify that the previous meeting minutes were added to the meeting agenda. 7. Click the Items to Process tab. to 6 eresearch Meeting Workspace Items to Process 8. Click the link on the agenda to open the meeting workspace for the previous meeting. 8 Last updated: 9/30/10 11 of 29 v.2.1

12 Add Meeting Minutes from Previous Meeting to Agenda eresearch Meeting Workspace Previous Meeting 9. Click View Printable Meeting Minutes to view the minutes. 8 Last updated: 9/30/10 12 of 29 v.2.1

13 Preparing and Mailing Agendas Preparing and Mailing Agendas eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting with the agenda you wish to send. 2 3 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 view the agenda sorted the by the reviewer. 4. Click Mail Out Agenda. 4 Last updated: 9/30/10 13 of 29 v.2.1

14 Preparing and Mailing Agendas Mail Out Agenda Window 5. Click OK. Note: The agenda will be sent to IRB staff and Committee Members. 5 Last updated: 9/30/10 14 of 29 v.2.1

15 Sending Out Special Notices (Optional Step) Important Information Sending Out Special Notices (Optional Step) You can notify all Committee Members by sending out special notices. eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting related to the message you wish to send. 2 Last updated: 9/30/10 15 of 29 v.2.1

16 Sending Out Special Notices (Optional Step) eresearch Meeting Workspace 3. Click Send Special Notice. 3 Send Special Notice Window 4 4. Enter the Special Notice. 5. Click OK. The Special Notice is sent to all Committee Members. 5 Last updated: 9/30/10 16 of 29 v.2.1

17 Updating Meeting Attendees Updating Meeting Attendees eresearch Committee Workspace 1. Click the name of the upcoming meeting related to the attendees you need to update. 1 eresearch Meeting Workspace 2. Click Edit Confirmed Attendees. 2 Edit Confirmed Attendees Window To add attendees as confirmed or declined, click Add in the appropriate section. Continue to Step To remove attendees as confirmed or declined, select the person and then click Remove in the appropriate section. Note: Committee Members who go in and accept or decline attendance themselves are automatically added to the list. Last updated: 9/30/10 17 of 29 v.2.1

18 Updating Meeting Attendees Select Person Window 5. To continue adding a person, select the person from the list. 6. Click OK. 5 6 Edit Confirmed Attendees Window 7. Click OK. 7 Last updated: 9/30/10 18 of 29 v.2.1

19 Updating Meeting Attendees eresearch Meeting Workspace 8. Attendees for the meeting are updated. 8 Last updated: 9/30/10 19 of 29 v.2.1

20 Conclude Meeting Conclude Meeting eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the upcoming meeting with the agenda you wish to send. 2 eresearch Meeting Workspace 3. Click Meeting Concluded. 3 Last updated: 9/30/10 20 of 29 v.2.1

21 Conclude Meeting Meeting Concluded Window 4. Click OK. 4 Last updated: 9/30/10 21 of 29 v.2.1

22 Record Committee Decision Important Information Recording Elements of Discussion 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. 1 eresearch Committee Workspace 2. From the Study Workspace, click Record Elements of Discussion. 2 Last updated: 9/30/10 22 of 29 v.2.1

23 Record Committee Decision Record Elements of Discussion Window 3 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 Last updated: 9/30/10 23 of 29 v.2.1

24 Record Committee Decision Record Committee Decision Important Information Once the submission is reviewed at the meeting, Core Staff record the decision in eresearch. The decision may include: Approved Approved with Contingencies Not Regulated Determination Exempt Determination Action Deferred Pending Study Team Disapproved Disapproved Final Tabled See Module 6: Validating Decisions for more information about each of these specific decision and related actions required with each decision. Study Workspace 1. Click Record Committee Decision from the Study Workspace. 1 Last updated: 9/30/10 24 of 29 v.2.1

25 Record Committee Decision Record Committee Decision 2. Enter Time of Vote 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 7 4. If applicable, select the Committee Member for Motion Made and Motion Seconded. 5. Enter Total Votes, Yes Votes, Abstained Votes, Abstained Members and No Votes. 6. Add Known Conflicted Committee Members and Members Out of Room, if applicable IRB Only: Select the length in months of the Approval Period for the study. 8. Click OK. Last updated: 9/30/10 25 of 29 v.2.1

26 Approve Meeting Minutes Update Meeting History Important Information: You can modify meeting minutes from a previous meeting using the Update Meeting History activity. eresearch Home Workspace 1. From your Home Workspace, click the name of the Submission to be updated. 1 eresearch Study Workspace 2. Click Update Meeting History. 2 Update Meeting History Window 3. Click next to the meeting to be updated. 3 Last updated: 9/30/10 26 of 29 v.2.1

27 Approve Meeting Minutes Update Meeting History Window Enter the Time of the Vote. 2. Select the Motion from the drop-down menu. 3. Select the Motion Made and the Motion Seconded. 4. Enter number of Total Votes, Yes Votes, No Votes and Abstained Votes. 5. Enter Abstained Members. 6. Enter Members Out of Room. 7. Enter Draft Elements of the Discussion. 8. Enter Final Elements of the Discussion. 9. Click OK Last updated: 9/30/10 27 of 29 v.2.1

28 Approve Meeting Minutes Approve Meeting Minutes eresearch Home Workspace 1. From your Home Workspace, click the name of the Committee. 1 eresearch Committee Workspace 2. Click the name of the past meeting with minutes to be approved. 2 eresearch Meeting Workspace 3. Click Record Committee Decision. 3 Last updated: 9/30/10 28 of 29 v.2.1

29 Approve Meeting Minutes Record Committee Decision Window Enter the Time of the Vote. 5. Select the Motion from the drop-down menu. 6. Select the Motion Made and the Motion Seconded. 7. Enter number of Total Votes, Yes Votes, No Votes and Abstained Votes. 8. Enter Abstained Members. 9. Enter Elements of the Discussion. 10. Click OK. 10 Last updated: 9/30/10 29 of 29 v.2.1