What to Include in a Modification SmartForm

Making any changes to the approved research will require a modification that must be reviewed and approved by the IRB before the changes go into effect.

Important! Updating the SmartForm does not send the submission for review. The PI or PI Proxy must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on for the next state of review.

To create and submit a Modification on an approved project to the IRB:

1. Log in to irb.harvard.edu

2. Navigate to an approved study workspace (see Accessing a Submission for more information).

3. Click the “Modify Study” button. 

4. Select “Modification/Update” 

5. Select one or both types of modification on the first page of the SmartForm. Note: ESTR will only allow one ‘Study team member information’ and one ‘Other parts of the study’ modification to be open at a time.

  • Selecting “Study team member information” allows for update to the study team members listed on the study or study team member related documents (such as human subjects training certificates or Financial Conflict of Interest forms)
  • Selecting “Other parts of the study” allows for revision to:
    • The Principal Investigator
    • The protocol 
    • Any Basic Information, including changing the study type to collaborative research where Harvard will review on behalf of at least one site
    • Funding for the study
    • Study Scope and related elements such as additional study locations, or the study of drugs or devices
    • Consent, recruitment materials, study instruments/tools and any other non-personnel study documents.

Image highlighting where to indicate a modification submission type

6. By selecting ‘Continue’ the system will guide you through some questions about the requested change, and take you to a copy of the SmartForm. Refer to the What to include in the SmartForm section for additional instructions for what is required for each element of the study SmartForm. 

7. Follow the remaining steps to Edit a Submission

8. The PI or PI Proxy must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on to the IRB for review.

  • To change the Principal Investigator on an approved study, select the “Other parts of the study” Modification scope.
  • Once a modification scope is selected and saved, it cannot be changed on that submission.
  • If the Add/Manage Participating Sites activity is not available on the approved main study workspace, propose the addition of a site to an approved study by:
    (1) Create a Modification to “other parts of the study” 
    (2) On the Basic Information page of the SmartForm, mark the study type as “Collaborative” and that “Yes” Harvard will review on behalf of at least one IRB; AND 
    (3) After modification approval, complete the “Add Participating Sites” activity on the main study workspace.
    If a site is added to an approved study, the IRB may request that the submission be accompanied by a modification to the study protocol.