Editing Studies

Agency-Specific Instructions: Department of Commerce (DOC). Editing Inclusion Study Records is not applicable for DOC awards.

Below is information specific to editing inclusion study records. More comprehensive help is found in the Human Subjects System (HSS) online help.

To edit study information, the Principal Investigators (PIs) or Signing Officials (SOs) can access the HSCT form using the Human Subjects links in either the RPPR or through the Status screen in eRA Commons.

Human subjects information may need to be updated in the following scenarios:

  • Post-award for updates to the Research Performance Progress Report (RPPR)
  • Pre-award (post review) for just-in-time (JIT) information or correction of human subjects data
  • Off-cycle updates as required in the Funding Opportunity Announcement or terms and conditions of award

To edit an existing study, log into eRA Commons and access the Human Subjects link via the RPPR or Status modules.

Status result for PI highlighting Human Subjects as an Available Action

Status result for SO highlighting Human Subjects as an Action

  • The Application Information screen is displayed, showing a summary of your grant. Click the Human Subjects Post Submission tab. This will take you to a summary page Study Record(s) screen where all study records and delayed onset studies associated with your grant are displayed.
    HSS tab in Application Information
  • Click the View button to bring up a study.
    Edit and View buttons highlighted on HSS Post Submission screen
  • To update the human subjects information on that study, including inclusion enrollment data, click the Edit button at the top of the screen.
  • Inclusion data is found at the end of Section 2
    Section 2 - Study Population Characteristics
  • There are two ways to edit the existing Inclusion Enrollment Report (IER) data for Cumulative (Actual) counts:
    1. You can update the cells online in the existing report itself.
    2. Or you can download a spreadsheet template for entering participant-level data by clicking the Download Participant Level Data Template button.
      • Fill the template out with data and then upload the spreadsheet by clicking the Upload Participant Level Data Attachment button. This uploaded data will populate the cells in the report.
      • You can click the Download Current Participant Level Data button to download the file containing the data for your own records.
        Cumulative (Actual) totals sections showing active buttons
  • Notes:
    • If you plan to upload the data, you must use the template by selecting the Download Participant Level Data Template. This will be a CSV file that can be updated with new totals.
    • Once the new totals have been entered into the template and the file has been saved, use the Upload Participant Level Data Attachment button to upload the file which will update the Cumulative counts.
    • Individual-level participant data on characteristics at enrollment will be required in progress reports for competitive applications submitted for due dates on or after January 25, 2019 (See NIH Guide Notice NOT-OD-18-116).
  • For the Planned counts, the cells must be updated online in the report itself.
    Planned totals section
  • The entire study can be previewed before submission by clicking the Preview Study button on the left navigational column under Actions.
    Preview Study button under Actions in left navigation

If the PI is making changes:

  • The PI can click the Save and Release Lock button to save the changes.
  • The submission status changes to Work in Progress.
  • PI changes status to Ready for Submission.
  • Signing Official (SO) gets an email that the application is ready for submission.
  • SO logs into ASSIST, finds the application and submits it.

If the SO is making changes:

  • The SO can click the Save and Keep Lock button to save the changes.
  • The submission status changes to Work in Progress.
  • SO changes status to Ready for Submission.
  • The Submit action becomes active on the Application Information page.
  • SO clicks on the Submit button

Only the SO can submit the application to NIH. The submission sends all updated study records associated with the application to NIH at one time.

Program officials and grant specialists are notified automatically of study changes and can review those changes. Some changes may require prior approval.