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Harvard School of Public Health Electronic Submission Tracking & Reporting - IRB Submitter Training December 10, 2012 PowerPoint PPT Presentation


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Harvard School of Public Health Electronic Submission Tracking & Reporting - IRB Submitter Training December 10, 2012. Topics for This Session. Module 1: ESTR Basics What is ESTR? Accessing the System General Site layout and navigation

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Harvard School of Public Health Electronic Submission Tracking & Reporting - IRB Submitter Training December 10, 2012

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Harvard school of public health electronic submission tracking reporting irb submitter training december 10 2012

Harvard School of Public HealthElectronic Submission Tracking & Reporting - IRB Submitter TrainingDecember 10, 2012


Topics for this session

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…


Module 1 estr basics

Module 1: ESTR Basics

  • What is ESTR?

  • Accessing the System

  • General Site layout and navigation

  • Personal Folder layout and navigation (inbox, other tabs)


Module 1 what is estr

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.


Module 1 accessing the system

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


Module 1 general site layout and navigation

My Inbox

Log off

Module 1: General Site layout and navigation

Regions of Personal Page Workspace

Profile Page

Inbox and Workspace Tabs

My Current Actions and Shortcuts.


Module 1 personal folder layout and navigation

Module 1: Personal Folder layout and navigation


Module 1 personal folder layout and navigation1

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


Module 2 project entry

Module 2: Project Entry

  • Entering a project

  • SmartForm Navigation

  • Change contact

  • Other Actions


Module 2 entering a project

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.


Module 2 smartform navigation

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.

Save/Exit

Jump To

Continue


Module 2 change contact

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.


Module 2 other actions

Module 2: Other Actions

Go –Live Note:

Active projects (from “new” through “approval”) will have a record and these actions will be available.


Module 2 continuing reviews and modifications

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


Module 2 continuing reviews and modifications1

Module 2: Continuing Reviews and Modifications


Module 2 continuing reviews and modifications2

Module 2: Continuing Reviews and Modifications

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


Module 3 project navigation

Module 3: Project Navigation

  • Study features

  • Study workspace navigation

  • Study workspace tab navigation

  • Workflows

  • Workflow Definitions

  • Activities Detail


Module 3 study features

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 relevantto the review and use the breadcrumb or Follow on tab to navigate through the records.

  • Applications have information in the database and documents attached.


Module 3 study workspace navigation

Module 3: Study workspace navigation

Study Status

Link to IRB Approval Letter

Study History, including opened/completed add-on submissions

My Current Actions and Shortcuts.


Module 3 study workspace tab navigation

Module 3: Study Workspace Tab Navigation

Go –Live Note:

Studies pre-populated with information from HIRBERT will contain limited information, as applicable.

HIRBERT Number

Study Title

PI with Department

Additional Person to Notify

Initial Approval Date

Review Type

Current Approval and Expiration date

Funding (ONLY if GMAS number was provided)

First Designated Institution

FDA, if triggered


Module 3 workflows

Module 3: Workflows

  • A simplified workflow appears on the project workspace.

  • This includes information about current state.

  • There is also a detailed workflow…


Module 3 workflow definitions

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


Module 3 activities detail

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


Module 4 project review

Module 4: Project Review

  • Review workflows

  • Department Review


Module 4 review workflows

Module 4: Review workflows


Module 4 department review

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.


Module 4 request changes

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.


Module 5 working with smartforms

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 5 creating a new study

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


Module 5 new study smartform

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.


Module 5 managing personnel pi faculty advisor

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


Module 5 managing personnel study team members

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.


Module 5 managing personnel primary contact

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.


Module 5 managing personnel editing email and guest lists

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


Module 5 new study smartform adding funding information

Module 5: New Study SmartForm – Adding Funding Information

  • Funding can be added when creating a New Study or during a Modification.

    • If your funding source was entered in GMAS, you can select it from the list by searching by Fund Number, PI, Grant Title, etc.

    • If your funding source is NOT entered in GMAS, you can enter the information in question #2 in the Funding Source page.

1

2


Module 5 continuing review modification smartforms

Module 5: Continuing Review/Modification SmartForms

  • The Continuing Review and Modification SmartForms are accessible from an approved study workspace

    • Select “Create Modification/CR”


Module 5 continuing review smartform

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


Module 5 modification smartform

Module 5: Modification SmartForm

  • The Modification SmartForm includes two distinct parts:

    • Summary of the proposed change(s)

      • Enrollment status

      • Subject notifications

      • Changes in risk level

      • Summary and Rationale of changes

    • 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


Module 5 creating a rni submission

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

Personal Workspace:

Study Workspace:


Module 5 rni smartform

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


Module 5 after completing a smartform

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

PI:

Study Team:


Module 6 more details

Module 6: More Details

  • System Notifications

  • Generating and Viewing Reports

  • Person Profile

  • Security Model

  • The future…


Module 6 system notifications

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


Module 6 generating and viewing reports

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.


Module 6 person profile

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


Module 6 security model

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.


Module 6 the future

Module 6: The Future…

  • There is a dedicated help desk [email protected]

    • 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.


Appendix

Appendix


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