1. Electronic Submission Tracking & Reporting - IRB Investigator/Staff Lab Session Training QIP Ed Series

2. Topics for This Session Study Management Working with a Migrated Study Access to a Study and Activities Other Actions in a Workspace At-a-Glance MOD or CR Steps System Notifications Reportable New Information Other Features Copy a Study Person Profile Generating and Viewing Reports

3. Working with a Migrated Study 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 Study team members are responsible for updating all additional information, including uploading important study documents (protocol, consent forms, etc.) at the time of the first modification or continuing review. This process is completed by submitting a modification, and updating all of the appropriate SmartForm questions. Studies pre-populated from HIRBERT will contain limited information. Steps to populate a migrated study 1.Go to irb.harvard.edu 2.Navigate to the migrated study workspace 3.Click the Create Modification/CR button. 4.Select Modification 5.Select BOTH types of modification on the first page of the SmartForm. 6.Clarify the rationale for the modification. If the request includes ONLY updating information in ESTR, clearly indicate that you are ONLY populating a migrated study. 7.Select continue to page through the SmartForm and make edits. 8.Make all changes directly into the SmartForm (for example, if you are making changes to the approved protocol document, navigate to the Study Scope page and Update the protocol document with the newest version). 9.When all the changes are complete, select finish. 10.You will be directed to the submission workspace. 11.Contact the study PI to complete the submit activity on the submission workspace.

4. Access to a Study and Activities Only members of a study team (PI, Primary Contact, and Study Team Members, or Faculty Sponsor) may make changes to a study. Your role dictates the activities you see in the study workspace. The primary contact of the study may be changed at any time –Complete the Assign Primary Contact activity, without IRB review. –If this person is also working on the study, he or she should also be included on the study team members page ActivitySubmission TypeRole S UBMIT ( WITHOUT PI ASSURANCE ) Initial Application Study team or Primary Contact S UBMIT AND P ROVIDE A SSURANCE Initial Application PI and Faculty Sponsor (if there is one) S UBMIT C HANGES : R ESPOND TO C LARIFICATION R EQUEST All Types PI, Primary Contact, Approved Study Team, and Faculty Sponsor (if there is one) S UBMIT C HANGES : R ESPOND TO M ODIFICATIONS R EQUIRED OR D EFERRAL All Types PI and Faculty Sponsor (if there is one) C REATE A M ODIFICATION /CR Modification, Continuing Review, Study Closure PI, Primary Contact, Approved Study Team, and Faculty Sponsor (if there is one) S UBMIT Continuing Review & Modification PI and Faculty Sponsor (if there is one) S UBMIT Reportable New Information (associated with a study) PI, Primary Contact, Approved Study Team, and Faculty Sponsor (if there is one) S UBMIT Reportable New Information (NOT associated with a study) Any person with an HUID

5. Other Actions in a Workspace To Submit this type of Information Click this buttonNotes Updates on a study that has not been submitted to the IRB for review. To edit a SmartForm that has not yet been submitted to (or back to) the IRB. Continuing review updates for an active study 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) The form identifies the type of information that must be reported. Select View Study to see the submitted SmartForm while a submission is in IRB review or once review is complete. Select Edit Study to edit the submitted SmartForm only while a submission is in: –Pre-submission –Clarifications are requested –Modifications are required –Deferred Otherwise, to change a study where review was completed; Create Modification/CR must be initiated.

6. At-a-Glance MOD or CR Steps 1.Log in to irb.harvard.edu [please do not use during training sessions] 2.Navigate to an approved study workspace –This is a submission numbered without letters or with the prefix IRB –The main study must not be in the middle of review 3.Click the Create Modification/CR button. 4.In the SmartForm, select the type of submission you would like to create (either Continuing review OR Modification) 5.If you are creating a modification, select one or both scopes of modification: –Note that only one of each type of modification can be created at a time. –If you are creating a modification, once you fill out the general information about the modification, you will be walked through a copy of the Study SmartForm. Please make all changes directly into the SmartForm. 6.Select continue to save and page through the SmartForm. When done, select finish to go back to the submission workspace. 7.If you are not the PI or Faculty Sponsor, email the PI or Faculty Sponsor (outside of ESTR) to inform them the submission is ready for the IRB review. The PI or Faculty Sponsor MUST complete the submit activity to send the submission for IRB review. Tips If you selected the wrong purpose of the submission, select back to exit. If you cannot exit or otherwise need to withdraw a modification or continuing review before it is approved, the withdrawal will not affect the review status of the project. Make sure the Primary Contact is correct. It can be changed from the main study workspace. A continuing review may be completed when a study is ready to be closed. When responding to clarifications during review, you will need to make changes directly in the SmartForm and someone on the approved study team must Submit Changes to proceed with the IRB review. IMPORTANT! In order to send the Continuing Review OR Modification for IRB review, the study PI or Faculty Sponsor will need to click the Submit activity button. Once the modification or continuing review is approved; the approval date, SmartForm, and all study documents will update in the main study workspace. Once a study is initially approved, the main study workspace always represents the currently approved materials for a study.

7. 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 –A person must have access to the study to receive a notice. –Notifications include a link to the submission workspace for easy access

8. Reportable New Information 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 If you want your report to remain confidential, do not associate the submission with a study.

9. Copy A Study The Copy Study activity is available to assist with: Creating new studies based off of standard features of a submission Creating a modification to a project already determined to be Not Human Subjects Research. –If a study received a NHRS decision BEFORE 8/29/13, request changes via Copy Study –If a study received a NHRS decision AFTER 8/29/13, the Create Modification/CR activity may be used. Steps 1.Log in to irb.harvard.edu 2.Navigate to the main study workspace of the project you want to copy 3.Select copy study in the submission. The system will pause for a moment while all the SmartForm information and attachments are copied. 4.Either refresh your browser page or navigate back to your InBox by selecting My InBox at the upper right of the screen. 5.The copied study is now in pre-submission for you to make edits and submit to the IRB office.

10. Person Profile Person information is imported from the Harvard Identity Management System. –Only those with an HUID can log in and will have a profile. –Others must request an HUID (process takes about three days) Training information may be entered and attached by IRB Staff Via the select view options, a person can create a default study team with which they often work. –This list will pre-populate into the Study Staff section of new applications and may be edited further, as needed.

11. Generating and Viewing Reports Pre-composed reports are available via the reports tab in the shortcut menu. –Expiring studies –Reportable New Information –Active studies

12. QUESTIONS? The ESTR system: irb.harvard.edu Tools and Tips: estrsupport.fss.harvard.edu ESTR Help Desk: ESTRhelp@harvard.edu