Electronic Submission Tracking & Reporting - IRB Investigator/Staff Lab Session Training QIP Ed Series. 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
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Steps to “populate a migrated study”
Go to irb.harvard.edu
Navigate to the migrated study workspace
Click the “Create Modification/CR” button.
Select BOTH types of modification on the first page of the SmartForm.
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”.
Select “continue” to page through the SmartForm and make edits.
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).
When all the changes are complete, select ‘finish’.
You will be directed to the submission workspace.
Contact the study PI to complete the ‘submit’ activity on the submission workspace.
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.
Notifications are generated in the system when an action is required.
An RNI (Reportable New Information) submission can be created:
If you want your report to remain confidential, do not associate the submission with a study.
The Copy Study activity is available to assist with:
Log in to irb.harvard.edu
Navigate to the main study workspace of the project you want to copy
Select “copy study” in the submission. The system will pause for a moment while all the SmartForm information and attachments are copied.
Either refresh your browser page or navigate back to your InBox by selecting ‘My InBox’ at the upper right of the screen.
The copied study is now in pre-submission for you to make edits and submit to the IRB office.