1. Harvard School of Public Health Electronic Submission Tracking & Reporting - IRB Submitter Training November 15, 2012

2. Topics for This Session Module 1: ESTR Basics What is ESTR? Accessing the System General Site layout and navigation Personal Folder layout and navigation (inbox, other tabs) Module 2: Project Entry Entering a project SmartForm Navigation Change contact Other Actions Module 3: Project Navigation Study features Study workspace navigation Study workspace tab navigation Workflows Workflow Definitions Activities Detail Module 4: Project Review Review workflows Department Review Module 5: Working with SmartForms Creating a New Study New Study SmartForm Managing Study Personnel Managing Funding Sources Continuing Review/Modification SmartForms Reportable New Information SmartForm After Creating a SmartForm… Module 6: More details System Notifications Generating and Viewing Reports Person Profile Security Model The future…

3. Module 1: ESTR Basics What is ESTR? Accessing the System General Site layout and navigation Personal Folder layout and navigation (inbox, other tabs)

4. Module 1: What is ESTR? ESTR is our new Electronic Submission Tracking & Reporting system. –Automates the IRB submission and review processes. –Is a place to store and access submission documents and meeting documentation. –Allows for easier reporting for business process and regulatory purposes.

5. Module 1: Accessing the System Go to irb.harvard.edu To access the system, you must: –Have an internet connection and have an HUID –Based on your HUID, you will have certain privileges in the system (more about this later) –Suggested browsers Internet Explorer 8 or later, Firefox 7 or later, Chrome 9 or later, Safari 4 or later, Firefox 3 or later, and Safari

6. Module 1: General Site layout and navigation Regions of Personal Page Workspace Log off My Inbox Profile Page My Current Actions and Shortcuts. Inbox and Workspace Tabs

7. Module 1: Personal Folder layout and navigation Check this list...For...How to find this list Personal WorkspaceAll workspace tabs below Click the My Inbox link in the top right navigation header or the IRB link in the top left navigation header My Inbox Studies assigned to you for action, such as a study you are: Preparing for submission Assigned to review Click either: The My Inbox link in the top right navigation header The IRB link in the top left nav header The My Inbox link in the left nav shortcut IRB In-Review Studies Studies the IRB has not reviewed or for which it has not communicated a decision Click IRB in the top left navigation area and select the In-Review Studies tab. IRB Active Studies Studies approved by the IRB and currently in progress Click IRB in the top left navigation area and select the Active Studies tab. IRB All Studies All studies entered into the system that you have permissions to view Click IRB in the top left navigation area and select the All Studies tab. Tip: Try filtering this list by the study name or principal investigator. Next to Filter by, select Name or Investigator. Then type the beginning of the name and click Go. IRB New Information ReportsReportable information submissions Click IRB in the top left navigation area and select the New Information Reports tab.

8. Module 1: Personal Folder layout and navigation IRB submissions that are assigned to you for action generally appear in My Inbox with a link to the submission. To access submissions assigned to you: –Click the My Inbox link in the top right navigation header. –Identify the reason it appears in My Inbox by looking at the State column. –Open the submission by clicking its short title in the Name column. To view the details of the study: –Click View Study on the left. –View details and navigate through the tabs to find History of changes Approved documents Current comment and status information

9. Module 2: Project Entry Entering a project SmartForm Navigation Change contact Other Actions

10. Module 2: Entering a project A new study for IRB review is entered into a series of online forms, called a SmartForm. –The number of form pages included may change based on the answers provided. –The forms tell the person completing the form where to attach files to provide supporting information. By selecting “Create New Study” from a Personal Workspace, a blank SmartForm is opened. When a study is created and a department is selected, the IRB Committee is automatically assigned. This drives security (either HSPH, HMS or CUHS will have access to studies in their committee). This can be changed later by the IRB Office.

11. Module 2: SmartForm Navigation Navigate the SmartForm by –Clicking Continue to save information and move to the next form. –Use Jump-to and save/exit When reaching the end of the series of forms, click the Finish button. –This only completes the SmartForm –The “Submit” or “Submit and Provide Assurance” Once an SmartForm is started, it can be edited any time prior to submission in the study workspace. Jump ToContinueSave/Exit

12. Module 2: Change contact The primary contact of the study may be changed at any time. This person will receive communication from the IRB about the study, and has full edit rights to the study, just like any other study team member. To change the primary contact: –Open the study –Click Assign Primary Contact from the My Current Actions. A popup appears –Clear the current contact and input the name of the current contact. Go –Live Note: Individuals listed as “Additional person to notify 1” in HIRBERT will be included as primary contact.

13. Module 2: Other Actions To Submit this type of Information Start here…Click this buttonNotes Updates on a study that has not been submitted to the IRB for review. Open the study by clicking on it. To edit a SmartForm that has not yet been submitted to (or back to) the IRB. Continuing review updates for an active study From the Active tab, click the study name. A continuing review and a modification can be submitted at the same time. There are two types of modifications: Personnel and Non-Personnel The first form prompts for the type of information to submit. Modifications for active study Reportable New Information (Adverse event) From the Active tab, click the study name. You can also create an RNI submission not related to a specific study from the Personal Workspace. The form identifies the type of information that must be reported. Go –Live Note: Active projects (from “new” through “approval”) will have a record and these actions will be available.

14. Module 2: Continuing Reviews and Modifications ESTR allows the ability to create a Continuing Review on an approved study in the system ESTR supports two types of modifications: –Personnel Change (not including PI) –All Other Changes One of each type of modification is supported at any given time in ESTR A user can create: –A Continuing Review –A Modification –A CR/MOD

15. Module 2: Continuing Reviews and Modifications

16. If a modification is already in process (not approved or withdrawn):

17. Module 3: Project Navigation Study features Study workspace navigation Study workspace tab navigation Workflows Workflow Definitions Activities Detail

18. Module 3: Study features Applications are submitted and given a number. –IRB means you are viewing the parent record for a study or an initial application. –CR means you are viewing a Continuing Review –MOD means you are viewing a Modification –RNI means you are viewing Reportable New Information Be careful to view information relevant to the review and use the breadcrumb or Follow on tab to navigate through the records. Applications have information in the database and documents attached.

19. Module 3: Study workspace navigation My Current Actions and Shortcuts. Study Status Link to IRB Approval Letter Study History, including opened/completed add-on submissions

20. Module 3: Study Workspace Tab Navigation Check this tab...For... History Information about each action taken on the application In-brief view of public and private comments Project ContactsList of individuals listed as contacts on a study. Documents Draft documents submitted for review Finalized documents Versioning information for each document Snapshots View of the application at each change in state (for example, the appearance of the smart from between pre-review and changes submitted) Go –Live Note: Studies pre-populated with information from HIRBERT will contain limited information, as applicable. 1.HIRBERT Number 2.Study Title 3.PI with Department 4.Additional Person to Notify 5.Initial Approval Date 6.Review Type 7.Current Approval and Expiration date 8.Funding (ONLY if GMAS number was provided) 9.First Designated Institution 10.FDA, if triggered

21. Module 3: Workflows A simplified workflow appears on the project workspace. This includes information about current state. There is also a detailed workflow…

22. Module 3: Workflow Definitions States that an IRB submission transitions through during its lifecycle Activities that can be performed in each state User roles that can perform each activity E-mail notifications that are triggered at specific points of the process

23. Module 3: Activities Detail Add Comment Manage Guest List Copy Study Edit Email List Submit & Provide PI Assurance Submit Withdraw Assign Primary Contact Add Private Comment New Initial Submission SmartForm New Continuing Review SmartForm New CR/MOD SmartForm New Modification SmartForm (Personnel) New Modification SmartForm (Full Amendment) New RNI SmartForm Researcher Profile SmartForm Conversion Issue Ancillary Approval Submit RNI Submit Changes Submit RNI Clarification Request Clarification by Committee Member Request Clarification by Dept Reviewer Issue Departmental Approval Request Clarification by Designated Reviewer Submit Designated Review Request Clarification by Advisor Assign IRB Contact Request Pre-Review Clarification Submit Pre-Review Submit RNI Committee Review Assign Designated Reviewer Assign to Meeting Edit Pre-Review Assign to Non-Committee Review Assign Reviewers Submit Committee Review Remove From Agenda Prepare Letter Send Letter Assign To Committee Review Close Terminate Suspend Submit RNI Pre-Review Review Required Modifications Finalize Documents Edit PI Proxy Track Ancillary Approvals Cede Initial Submission Reassign IRB Send to Department Review Update Expiration Date Move to Approved Record IRB Approval Information Record IRB Actions Edit Meeting Information Prepare Agenda Send Agenda Assign Reviewers Notify Reviewers Edit Meeting Attendance Confirm Attendance Decline Attendance Prepare Minutes Convene Meeting Record Meeting Attendance Submit Committee Review Reschedule Meeting Close Meeting Approve Meeting Minutes Edit Committee Info Edit Members Update Eligible Designated Reviewers Administration Continuing Review Deadline Passed Continuing Review Closed Continuing Review Opened Created Study Modification Opened Reportable Information Opened Modification Approved

24. Module 4: Project Review Review workflows Department Review

25. Module 4: Review workflows Submitted Student Project Faculty review (Faculty member is PI) IRB Review Non-Exempt Yes: Dept. Review No or Dept. Review Complete: proceed with review (request clarifications, record ancillary reviews and other actions are possible) through to Non- Committee or Full Committee Determination. Post Review Finalize documents Set Expiration Date Prepare and Send Letter

26. Module 4: Department Review Once an initial application is submitted, IRB staff determine if Department review is required. –Based on the IRB’s SOPs: The study is non-Exempt The study may not be ceded to another institution The study is conducted by a faculty member Department is pre-selected by the Principal Investigator with the submission. IRB staff may select “Send to Department Review” activity. When in Department Review, the study is locked from edits unless changes are requested by Department Approver.

27. Module 4: Request changes By selecting a Request Clarification activity, clarifications may be listed and supporting documents attached. Once submitted back by the study team, changes may be verified To view and verify requested changes: –Select View Differences activity. –On the View Changes to IRB Submission page, use the dropdown to select the version that you want to compare to the current version. –If more than one change has been made, use the arrows or dropdown selector next to the Changed Steps to navigate through the changes.

28. Module 5: Working with SmartForms Creating a New Study New Study SmartForm Managing Study Personnel Managing Funding Sources Continuing Review/Modification SmartForms Reportable New Information SmartForm After Creating a SmartForm…

29. Module 5: Creating a New Study A SmartForm is a series of webpages in the system that is used to collect information about your research, research progress (continuing review), requested changes to approved research (modifications) or reportable new information. To create a new study, click “New Study” in the personal Workspace – this will create a new study SmartForm, and guide you through the submission process

30. Module 5: New Study SmartForm The New Study SmartForm is made up of the following pages: –Basic Information Study Title, PI Name, Department, etc. –Funding Sources Links to GMAS projects, other non-sponsored funding –Study Personnel All other study team members affiliated with Harvard –Study Scope Affirmative answers are branched to specific questions on external sites, drugs or devices. –External Sites* –Drugs* –Devices* –Consent, Assent, HIPAA Upload any consent materials –Other Supporting Documents Upload any other important information * These pages are only visible if selected on the study scope page.

31. Module 5: Managing Personnel – PI & Faculty Advisor The PI/Faculty Advisor can be added to a study when creating a new study or by doing a full modification. PI/Faculty Advisor is responsible for executing the “Submit and Provide Assurance” activity for new studies PI/Faculty Advisor is sent all system notifications re: the study

32. Module 5: Managing Personnel – Study Team Members Personnel can be added to a study when creating a new study or by doing a personnel change modification Personnel changes must be reviewed and approved by the IRB before the change takes effect in the system –So, a user added today will not have view/edit rights to the study until the modification is approved by the IRB.

33. Module 5: Managing Personnel – Primary Contact A Primary Contact can be added at any time in the study workspace –Addition/Change of Primary Contact does NOT go through IRB Review/Approval – the change happens immediately –Primary Contacts have view/edit rights to the study, and are CC’d on all system notifications –Only 1 Primary Contact can be added for each study.

34. Module 5: Managing Personnel – Editing Email and Guest Lists Edit Email List: This activity on the study workspace allows approved study team members to receive all email notifications sent to the PI & Primary Contact Edit Guest List: This activity on the study workspace allows the study team to allow VIEW-ONLY access to the study submission for users who are not listed on the study Edits to the Email and Guest Lists do NOT go through IRB Review/Approval process – the change happens immediately

35. Module 5: New Study SmartForm – Adding Funding Information Funding can be added when creating a New Study or during a Modification. 1.If your funding source was entered in GMAS, you can select it from the list by searching by Fund Number, PI, Grant Title, etc. 2.If your funding source is NOT entered in GMAS, you can enter the information in question #2 in the Funding Source page. 1 2

36. Module 5: Continuing Review/Modification SmartForms The Continuing Review and Modification SmartForms are accessible from an approved study workspace –Select “Create Modification/CR”

37. Module 5: Continuing Review SmartForm The Continuing Review SmartForm captures: –Enrollment Totals –Vulnerable Population Enrollment –Research milestones –Date last subject enrolled –Any additional harms, benefits, unanticipated problems, complaints, advances, findings, reports, risks, modifications, or problems

38. Module 5: Modification SmartForm The Modification SmartForm includes two distinct parts: 1.Summary of the proposed change(s) Enrollment status Subject notifications Changes in risk level Summary and Rationale of changes 2.Modification Details This next set of forms will be a copy of the approved study. Research teams will make all changes to the SmartForm, for example: –Remove/add study team members –Replace a consent form or protocol document with an updated version

39. Module 5: Creating a RNI Submission An RNI (Reportable New Information) submission can be created: –From the personal workspace for RNIs NOT associated with a particular study –From the approved study workspace for RNIs related to that specific study Study Workspace: Personal Workspace:

40. Module 5: RNI SmartForm The RNI SmartForm captures the following information: –Date PI became aware of the information –Categories of the new information (New Risk, Harm, Audit, Report, Research Error, Complaint, etc.) –Description of the information –If the new information: Poses a change to the study risk(s) Requires a modification to the approved research

41. Module 5: After Completing a SmartForm… Once all of the information is complete in the SmartForm, the user is taken back to the study workspace. The “Submit” (anyone on the study team, or for all follow-on submissions) or “Submit and Provide Assurance” (PI/Faculty Advisor for new studies) activity must be executed in order for the study to move to the next state Study Team: PI:

42. Module 6: More Details System Notifications Generating and Viewing Reports Person Profile Security Model The future…

43. Module 6: System Notifications Notifications are generated in the system when an action is required. –PI & Primary Contact are both included on all system notifications –Other study team members can be added by using the “Edit Email List” activity in the study workspace –Notifications include a link to the submission workspace for easy access

44. Module 6: Generating and Viewing Reports Pre-composed reports are available via the reports tab in the shortcut menu. –Expiring studies –Reportable New Information –Active studies Some reports have additional information that may be analyzed for multiple purposes. If a report is needed and not available, contact FSS to create a custom report.

45. Module 6: Person Profile Person information is imported from the Harvard Identity Management System. At this time, only those with an HUID can log in and have a pre-loaded profile. Training information may be entered and attached. Go –Live Note: Non-HUID holders must requested an HUID Must have a Harvard- based sponsor Takes about three days to process and appear in the system Personnel Roster may be modified to list only non- HUID staff and attached to the personnel section of the SmartForm

46. Module 6: Security Model Every person with an HUID has “study staff” user rights. –Create a study (on behalf of someone else) –View studies on which they are staff, guest, or contact Additional access builds upon this base (hierarchical model). Examples: –Department reviewers See active projects in their department Able to issue Department approval –IRB Directors See all active projects under the IRB Complete review activities and other actions that move an application back and forth through a workflow –Board Members See all active projects under the IRB Complete review activities.

47. Module 6: The Future… There will is a dedicated help desk ESTRhelp@harvard.edu –For help –For immediate need change requests –For access changes Training documents will be available –With details about how the system functions (including the notification schedule, security settings, and detailed workflows) Share any questions with Alisa to include in training documents and FAQ. There will be an enhancement schedule and regular meetings to talk about system use.

48. Appendix