#  Creating a Follow-On Submission after Study Approval 

 



All submissions associated with a study after the initial creation are called “follow-on” submissions. These include submission types: Modification/Update, Continuing Review, Site, and Reportable New Information.

Sort**To submit this type of information...**

**Start here...**

**Notes**

**Modifications** to an active study

**Continuing review** updates for an active study

**Request to close study**



From the Active tab, click the study name (see [Accessing a Submission](/accessing-submission)).

In the Study workspace, click this button:

   ![Image of the buttons to create MOD CRs](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/followonbutton.png?itok=OAhXgWko) 

 



You can submit a continuing review and a modification at the same time. The first form prompts you to identify the type of information to submit.   
To request study closure, submit a Continuing Review. Based on the research milestones completed, the study may be closed.  
  
To modify an External IRB project, see the Updating External IRB Review section in [Requesting External IRB Review](/ExternalIRB).

**Modification or update to an active site**

From the Sites tab, click the site name (see [Accessing a Submission](/accessing-submission)).

In the Site workspace, click this button:

   ![View modify a site button](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/modifysite.png?itok=6R5472g2) 

 



You can submit a modification request which is specific to sites.

To provide a status update or request site closure, complete the Report Continuing Review Data activity in the site workspace and indicate the request to close in the text of the activity.



**New Information** or an adverse event report

For Information about a **particular study**, start from the Active tab, click the study name (see [Accessing a Submission](/accessing-submission))

For information affecting **multiple studies start in one o the studies and add studies within the form.**

Click this button:

   ![Image of the button to create an RNI](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/rnibutton.png?itok=q_xDU5vJ) 

 



Report new information as soon as you become aware of it. The form identifies the types of information you must report.







 

- [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")