Investigators participating in Usona Institute’s Investigational Drug and Material Supply Program are required to report certain safety data to Usona. This information is required to ensure Usona’s regulatory compliance as a manufacturer of an investigational drug.
1. Serious Adverse Event (SAE) Reporting
The sharing of safety reports between Usona and sponsors conducting clinical research utilizing Usona’s investigational products is a regulatory requirement.
Notification of SAEs: Within 5 days of identifying an SAE, Usona must be notified. Please submit notice to safety@usonainstitute.org.
Quarterly Safety Reporting:
- SAE reports should be submitted to Usona quarterly for SAEs that do not require expedited reporting.
- These reports can be detailed on institutional safety report forms, or FDA 3500A or CIOMS I forms.
- Include all necessary follow-up reports that pertain to the original SAE.
SUSAR (Suspected Unexpected Serious Adverse Reaction) Reporting:
- IND Sponsors must report to their regulatory authority any suspected adverse reaction to study treatment (including comparators) that is both serious and unexpected (21 CFR 312.32(c)(1)(i)). For SAEs that meet the criteria for expedited reporting to a regulatory authority, submit a copy of FDA 3500A or CIOMS I to safety@usonainstitute.org.
- Copies of expedited safety reports should be provided to Usona on the following timelines:
- 7-day reporting for SAEs that are both serious and unexpected.
- 15-day reporting for other significant SAEs requiring expedited review.
- The safety report must include an assessment of whether there is a reasonable possibility that the drug caused the event (21 CFR 312.64(b)).
Include all necessary follow-up reports that pertain to the original SAE.
2. Annual Reporting
Usona is required to submit an Annual Report or Development Safety Update Report (DSUR) to the FDA on an annual basis.
By February 15th of each year, you must:
- Complete the Usona Institute IIT Safety Update Form.
- Send the completed form to safety@usonainstitute.org.
To facilitate timely and comprehensive reporting, Usona will also initiate a request for safety data each July.
Download the IIT Safety Update Form
3. End of Study Reporting
At the conclusion of your study, please provide the following:
- A copy of any publication that results from use of the investigational drug at least fifteen (15) days prior to submission and, if accepted by a peer-reviewed publication, within thirty (30) days following release. Usona should be acknowledged as the provider of the investigational drug.
- A copy of the final report/notice provided to the IRB or ethics committee.
- Submit a safety data summary report to IIT End of Study Reporting. A template of the information to be contained in the safety data summary report can be found here: IIT End of Study Reporting.
Do not include any personally identifiable information (PII) in any of the above reports.
The above instructions only cover your reporting obligations to Usona Institute. As a sponsor of a clinical study under an IND, you will have additional reporting requirements under applicable law that are not addressed here.
Additional information on safety reporting is available in FDA Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies.
Questions about the information outlined above should be directed to invdrug@usonainstitute.org.