Investigators participating in Usona Institute’s Investigational Drug and Material Supply Program are required to report all serious adverse events (SAEs) to Usona within 5 days. This information is required to ensure Usona’s regulatory compliance as a manufacturer of an investigational drug.
1. Serious Adverse Event (SAE) and adverse events of special interest (AESIs)
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 safetyreporting@usonainstitute.org.
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 safetyreporting@usonainstitute.org
- 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 safetyreporting@usonainstitute.org
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 the 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 Investigational Review Board 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.