Report Forms

The ERICA Report Form application is used to submit problems, events, or information to the IRB for review. When a Report Form application is created, the application will ask the investigator to select what type of report they would like to submit.

Examples of problems or events include, but are not limited to, the following:

• Unanticipated problems or events
• Adverse events (if the AE meets the criteria for an unanticipated problem)
• Deviations
• Adverse device effects
• Breaches of confidentiality or privacy

Examples of information include, but are not limited to, the following:

• Data and safety monitoring Reports
• New information about the study (e.g., from the sponsor, the FDA, other regulatory agencies, etc.)
• Changes in FDA labeling, drug or device withdrawal from marketing
• Incarceration of a participant
• Complaints from participants (if the complaint meets the criteria for an unanticipated problem)
• Warning or determination letters
  
  

Submitting a Report Form in ERICA

1. Open the study
2. Click on the Report Forms tab
3. Click on the File a Report Form button
4. Complete the report form entirely
5. Attach any supporting documentation to the Report Form in the indicated sections
6. If you are submitting an Amendment in conjunction with the report, link the Report Form to the Amendment in the "Report Forms" section of the Amendment application
7. Submit the Report Form to the IRB for review
   
   

Frequently-Asked Questions About Report Forms

What does the IRB do with Report Forms after they are submitted?

• An IRB Administrator and/or a member of the Unanticipated Problems (UP) Subcommittee will conduct an initial review of all reports that are submitted. If it is determined in the initial review that this report may represent an unanticipated problem (UP) involving risk to participants or others, then the convened IRB will review the report to make a final determination.
• All reports that need to be reviewed by the convened IRB will be assigned to the next available meeting. You will receive an email notification from the ERICA system if a report is assigned to a meeting.
• For full details on prompt reporting and unanticipated problems, please see the IRB’s page regarding Unanticipated Problems (UP).

I used to submit this information via an Amendment application. How do I know if I should submit an Amendment, or Report Form?

• If you are asking the IRB for approval of a change, submit an Amendment.
• If you are giving the IRB information (adverse event, deviations, other new information), submit a Report Form.
• If you have new information that will also require changes to your application, protocol, consent form(s), etc., submit a Report Form AND an Amendment.

I need to submit a Report Form AND an Amendment. How can I alert the IRB that the two applications are related to each other?

• If you need to submit a Report Form and an Amendment together, you will need to link them in ERICA.
  1. Complete the Report Form first.
  2. Then, create the Amendment that corresponds to the reported problem, event, or information.
  3. In the Amendment application, select the corresponding report form from the list on the “Report Forms” page.
  4. Submit the Report Form and the Amendment.
• For more information, please read: What Should I Submit - Amendment or Report? [PDF]
• Please see: Report Form FAQs [PDF] for additional guidance.

How do I attach a document to a Report Form? Will the document move to the study's "Documents and Attachments" page after the Report Form is processed?

• The Report Form has fields for attaching the following types of documents:
  • Relevant documentation for a deviation
  • Adverse event documentation
    • Medwatch reports
    • CIOMS
    • Other sponsor specific forms
    • Chart notes, etc.
  • Relevant documentation of new information
    • DSMB reports
    • Letters from sponsors
  • Audit reports, etc.
• Do not attach revised or updated protocols, consent forms, or other documents that have been changed in the Report Form. These documents must be submitted via an Amendment application, which can be submitted at the same time as the report. Revised protocols, consent forms, or other documents will NOT be approved if attached in the Report Form. The Report Form is a mechanism for the IRB to review information, not approve updated or revised documents.

Additional Resources

• Amendment vs. Report Form [PDF]
• Self Assessments