#  Changing Documents on a Study 

 



You may need to modify a study's documents when:  
> The IRB requires changes prior to approval.  
> Submitting a modification to an approved study.

**To change documents prior to study approval:**  
Note: These steps also apply if the IRB decision was modifications required, disapproved, or deferred.

1\. From My Inbox, click the name of the submission to open the workspace

2\. Click the **Documents tab**

   ![Imaging highlighting the documents tab](/sites/g/files/omnuum886/files/styles/hwp_1_1__720x720_scale/public/estr/files/documenttab.png?itok=kd5PVA7A) 

 

3\. Click the document in the Draft column and save it to your computer

   ![Image highlighting the draft column on the documents tab](/sites/g/files/omnuum886/files/styles/hwp_1_1__720x720_scale/public/estr/files/draftcolumn.png?itok=Cl6rYQcm) 

 

4\. Open the saved document and make edits (Enable the Tracked Changes feature as needed. When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.)

5\. When finished with the changes, save the revised document

6\. Go to the submission workspace and click **Edit Study** on the left. For Modifications or Continuing Reviews, click Edit Submission.

7\. Navigate to the location of the current document within the SmartForm by clicking Continue on the right

8\. Replace the original study document with the revised version by clicking “Update” beside the document on the SmartForm, or use other controls to make document changes.

   ![Document control options](/sites/g/files/omnuum886/files/styles/hwp_1_1__720x720_scale/public/estr/files/documentcontrols.png?itok=qLRQ7ReY) 

 

9\. Complete any further updates and submit the changes for further review. See the section [Editing a Submission](/editing-submission) for further details.

**To change documents on an approved study:**

1\. Click **IRB** in the top navigation area and select the **Active** tab.

   ![Image highlighting the Active tab](/sites/g/files/omnuum886/files/styles/hwp_1_1__720x720_scale/public/estr/files/activetab.png?itok=OgiYfXDa) 

 

2\. Click the name of the approved study.

3\. Click the **Documents** **tab**.

   ![Imaging highlighting the documents tab](/sites/g/files/omnuum886/files/styles/hwp_1_1__720x720_scale/public/estr/files/documenttab.png?itok=kd5PVA7A) 

 

4\. Click the document in the Draft column and save it to your computer. In some cases, this document may contain previously approved tracked changes and comments. To update contents content match the current final-approved version, use the review features in Word to accept all the changes and remove any comments. Use this clean document as a starting point for your revisions.  
  
5\. Open the saved document and make edits (Enable the Tracked Changes feature as needed. When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.)

6\. When finished with the changes, save the revised document

7\. Go to the approved study workspace and create a modification to update the SmartForm and submit the proposed changes for IRB review. See the section [Creating a Follow-On Submission after Study Approval](/create-followon) for further details.



 

- [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")