#  Creating a New Study 

 



You can create a new study for IRB review by entering information into a series of online forms. The number of forms included may change based on the answers you provide. The forms tell you where to attach files to provide supporting information. The forms may contain required information identified by a red asterisk (\*), you cannot proceed without providing that information. A required attachment to the Basic Information form is a Word document that describes the research: either the Protocol Template or the Not Human Subjects Research Determination Request. Additional documents should be attached to the forms where appropriate, such as recruiting, consenting and debriefing subject material. It is recommended that these documents be prepared prior to creating the new study; templates and guidance are available on your IRB website.

The simplest approach is to follow the forms in order, answering the questions and clicking Continue to save your information and move to the next form. When you reach the end of the series of forms, click the Save & Exit button.

**To create a new study for review:**

1. From My Inbox or IRB pages (linked in the top menu), click **Create New Study**.
    
       ![Button Image for Create New Study](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/createnewstudy.png?itok=wDlGYIhc)
2. Fill in the applicable boxes, answer the questions, and attach appropriate documents.
3. Click **Continue** to move to the next form.
    
       ![Image of SmartForm menu highlighting continue button](/sites/g/files/omnuum886/files/styles/hwp_1_1__960x960_scale/public/estr/files/smartformpageforward.png?itok=Qbl-OKkT)
4. Click the ‘**jump to**’ menu to go to a specific section.
    
       ![Image of the SmartForm jump to menu](/sites/g/files/omnuum886/files/styles/hwp_1_1__360x360_scale/public/estr/files/smartformjumpto.png?itok=X--JtqKp)
5. To save or exit the SmartForm at any time, click on “Save” and “Exit” button in the top toolbar. Exit will take you to that submission’s workspace.
    
       ![Image of the SmartForm menu highlighting save and exit](/sites/g/files/omnuum886/files/styles/hwp_1_1__960x960_scale/public/estr/files/smartformsaveexit.png?itok=b32ASSz_)
6. When you reach the final page, click **Save & Exit** to exit the study.  
    You can continue to edit the study until you submit it for review. See [Editing a Submission](/editing-submission).

**Important!** The study has not been submitted for review yet. For instructions, see [Submitting the Study for Review](/submitting-a-study).

Sort**TIPS**

- If a study team member plans to create a new study which is similar to a previous one, the PI on the previous study can complete the Copy Submission activity to create a partially completed form to update and further edit prior to submission to the IRB for review.
- Documents can be added to SmartForm spaces by dragging and dropping them from a location on your computer. There are two different ways to do this, depending on the prompt provided on the form.

   ![Drag and drop options](/sites/g/files/omnuum886/files/styles/hwp_1_1__960x960_scale/public/estr/files/dragndropoptions.png?itok=X93XYu-U) 

 

- Items that are added, but need to be removed may be either updated or removed in the following ways.

   ![Update item button](/sites/g/files/omnuum886/files/styles/hwp_1_1__960x960_scale/public/estr/files/updateitem.png?itok=mRBctQI2) 

 

- A continuing review, modification, or RNI (reportable new information) submission can be handled similarly to a study. For differences, see [Creating a Follow-On Submission after Study Approval](/create-followon).
- Reference the [**Library**](https://irb.harvard.edu/IRB/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B932925EBAB2E8C458897BE431933015B%5D%5D) (linked on the left side of any workspace screen) any templates/forms that are requested within the SmartForm, along with guidance materials.
- A red asterisk (\*) precedes each question that requires an answer. If you cannot answer a required question at this time, or if you need to stop and continue at a later time, you can save and return to the submission later. You must provide all required information before you can submit the study for review.









 

- [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")