# Submitting a Study for Review After entering all required information into the SmartForm and attaching files, the Principal Investigator must submit the study for IRB review. Sort**TIPS** - Make sure you attach all applicable information to the study, as identified in [Checklist of Information to Attach](/checklist-study-smartform-attachments). - Check for missing information before attempting to submit the study, as described in [Checking the Study for Errors](/check-submission-errors). Any errors or omissions not corrected are shown when attempting to submit the study and must be corrected before you can submit it for review. **To submit the study for IRB review:** **Important!** Only the Principal Investigator(PI) can complete the following steps for an initial application. Once a study is approved, the PI can assign a proxy to submit modifications or continuing reviews on his/her behalf. See [Managing Principal Investigator (PI) Proxy](/about-pi-proxy). 1\. Log in to [irb.harvard.edu](https://irb.harvard.edu) 2\. Make sure you are in My Inbox. If you do not see My Inbox, click the **My Inbox** link (in the top navigation menu) 3\. Click the name of the submission to open it. It should be in the Pre-Submission state ![Image of the inbox with the name of submission highlighted](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/submissionininbox.png?itok=zwh2AjNY) If the study does not appear on this list, perhaps it was already submitted, or it does not include you as a study team member. To find the study, try clicking **IRB** in the top left navigation area. If you do not see it in that list, see [Accessing a Submission](/accessing-submission) for more ideas. 4\. Click the **Submit** button (marked with a red arrow) from the Next Steps list on the left. ![Image of the submit activity](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/submitstudy.png?itok=OBro4AgN) 5\. The system will conduct an ‘error check’ to identify if any required questions were missed. If any errors or warnings are shown, click the link in the Jump To column to go to the form containing the problem. For more information, see [Checking the Study for Errors](/check-submission-errors). When all errors are corrected, try submitting the study by clicking Submit again. 6\. Click **OK** to agree to the PI assurance statement presented on the screen. If you would like to separately refer to the PI assurance statement - Before completing the activity: Click on the Submit activity, but choose cancel to close the window after reading. - Once the Submit activity is completed: Click on the name of the activity on the History details of the workspace to read elements of the activity form. - Refer to the [IRB Library, Other Reference Tab](https://irb.harvard.edu/IRB/sd/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B932925EBAB2E8C458897BE431933015B%5D%5D#9B0102C0FB51E240A57B3A70BD4827D1) to view of the [assurance text](https://irb.harvard.edu/IRB/sd/Doc/0/Q91Q4P8EHVMKP8G80S8DPVHDAD/Principal%20Investigator%20Assurance-Reference.pdf). When an initial study, modification/update or continuing review is submitted to the IRB office; the PI, PI Proxy and Primary Contact receive a notice confirming that the activity is completed. This notice also includes reference to the PI assurance statement. Submitting information to the IRB initiates a series of activities that may include: - Review within your department - Pre-review by an IRB staff member - Review by the IRB committee or a designated reviewer - Communication of the IRB decision to the investigator Any of these may lead to a request for the study team to take further action, such as providing clarifications or modifying the study. **Whenever the study team needs to act, the PI receives an e-mail notification, and the study appears in My Inbox for all study team members when they log in to the IRB system.** **Important!** Make sure the appropriate person is listed as the primary contact to receive e-mail and see the study in My Inbox (along with the PI and any PI proxies, who also receive these). By default, the person who created the study is the primary contact. See [Changing the Study Primary Contact](/change-primary-contact). - [Logging In](/logging-in "Logging In") - [Creating a New Study](/creating-new-study "Creating a New Study") - [Study SmartForm](/study-smartform "What to Include in a Study SmartForm") - [Site SmartForm](/site-smartform "What to Include in a Site SmartForm") - [SmartForm Attachments](/checklist-study-smartform-attachments "Checklist of SmartForm Attachments") - [External IRB Submission](/ExternalIRB "Requesting External IRB Review") - [Editing a Submission](/editing-submission "Editing a Submission") - [Checking for Errors](/check-submission-errors "Checking a Submission for Errors") - [Submitting a Study](/submitting-a-study "Submitting a Study for Review") - [Checking the Status](/check-the-status "Checking the Status of a Submission") - [Accessing a Submission](/accessing-submission "Accessing a Submission") - [Responding to the IRB](/responding-to-irb "Responding to a Request for Clarifications or Modifications") - [Changing Study Documents](/changing-study-documents "Changing Documents on a Study") - [Communicating with Staff](/communicating-with-staff "Communicating with Staff During Review") - [Managing Related Projects](/managing-related-projects "Managing Related Projects") - [Finding the IRB Decision](/finding-IRB-determination "Finding Determination Letters and Approved Documents") - [Managing PI Proxy](/about-pi-proxy "Managing Principal Investigator (PI) Proxy") - [Changing a Primary Contact](/change-primary-contact "Changing the Study Primary Contact") - [Managing Guests](/about-study-guests "Managing Guests with View-Only Permissions to the Study") - [Copying a Study](/copy-submission "Copying a Study") - [Creating a Follow On](/create-followon "Creating a Follow-On Submission after Study Approval") - [Modification SmartForm](/mod-smartform "What to Include in a Modification SmartForm") - [Renewal(CR) SmartForm](/cr-smartform "What to Include in a Continuing Review SmartForm") - [RNI SmartForm](/rni-smartform "What to Include in a Reportable New Information SmartForm") - [Site Modification (for External IRB Update)](/ExternalIRB "Requesting External IRB Review") - [Closing a Study](/study-closure "Closing a Study") - [Generating Reports](/generating-reports "Generating Standard Reports")