What is the Report Form used for?
The report form is used to submit problems, events, or information to the IRB for review.
Examples of problems or events include, but are not limited to, the following:
- unexpected, related adverse events (click to see full policy)
- protocol deviations (click to see full policy)
- adverse device effects
- breaches of confidentiality or privacy
Examples of information include, but are not limited to, the following:
- DSMB 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 that cannot be resolved by the PI
- warning or determination letters
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 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 full Unanticipated Problems policy.
Amendments versus Reports
If you are asking the IRB for approval of a change, submit an amendment. If you are giving the IRB information (adverse event, protocol deviations, other new information), submit a report. If you have new information that will also require changes to your application, protocol, consent form(s), etc., submit a report AND an amendment.
If you need to submit a report and an amendment together, you will need to link them in ERICA. To do this, complete the report form first. Then create the amendment that corresponds to the reported problem, event, or information. In the amendment application, on question 3.1, select the corresponding report form from the list. Submit the report form and the amendment.
For more information, please read What should I Submit-Amendment or report?
Attaching Documents to Reports
The report form has fields for attaching the following types of documents:
- Relevant documentation for a protocol deviation
- Adverse event documentation
- Medwatch reports
- CIOMS
- Other sponsor specific forms
- Chart notes, etc.
- Relevant documentation of new information
- DSMB reports
- Letters from sponsor
- 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.
Submitting a Report Form in ERICA
- Open the study.
- Click on the Report Forms tab.
- Click on the File a Report Form button.
- Complete the report form entirely.
- Attach any supporting documentation to the report form in the indicated sections.
- If you are submitting an amendment to conjunction with the report, link the report to the amendment in section 3.1 of the Amendment Application.
- Submit the report to the IRB for review.
Please see Report Form FAQs for additional guidance.
