Submit an Adverse Event
How to submit Adverse Events can unfortunately be complicated and/or confusing. It is important to keep in mind that the UF IRB needs to see information that affects the safety and well being of subjects who participate in the protocol being conducted (and reviewed by the IRB) here (or by our investigators elsewhere).
Different Kinds Of Events
- Events on Other Protocols
- Typically reported to you by outside agency / sponsor, probably using the same or similar drugs: the UF IRB doesn’t want you to report these events to us because (1) we haven’t reviewed the other protocols, so we don’t know much if anything about them, including (2) what condition was being studied, (3) what type of patient was being enrolled, (4) what other treatment modalities were included in the research, and/or (5) how use of the shared treatment (drug) is different. Obviously it is essentially impossible for the IRB to evaluate these “off protocol” events, and we therefore will not accept them UNLESS the PI and sponsor specifically determine that the event presents risks to subjects enrolled on our study. In this event the PI must submit the Serious and Unexpected Adverse Event & Safety Report Form (aka the “5 day form”).
- Events on Our Protocol
Here or elsewhere. An event has happened to a subject here on your study, or to a subject at another site but who was enrolled on the same protocol. What you need to submit and when is determined by the specifics of the Adverse Event. Is the event:
- serious or not serious?
- expected or unexpected?
- related or not related?
- local or non-local?
Obviously it is critical to understand what these terms mean in order to properly evaluate the event and then be able to determine what needs to be submitted when. Review our Adverse Event Definitions.
Once you can answer the seriousness/expectedness/relatedness/location questions, our Adverse Event Evaluation Guide will help you determine if you need to submit the event promptly (within 5 days of discovery) via our Serious and Unexpected Adverse Event & Safety Report Form, if it can wait to be reported until your next Continuing Review or Study Closure on our Cumulative Adverse Event Table, or if you don’t have to submit anything at all.
Sometimes you may discover a serious and unexpected adverse event but it is not fully resolved (gone away). For example, a subject may have an adverse reaction to a drug and be hospitalized. Do not wait for the hospitalization to finish before reporting to the IRB. You should report to the IRB quickly with as much information as possible (no later than within 5 days). If subsequent follow-up information becomes available (subjects worsens, different treatment is needed, subject gets better, etc), you should submit an additional Serious and Unexpected Adverse Event & Safety Report Form, this time indicating the “Subject Identifier” line (question 5) not only the same subject identifier as used previously, but also that this is a follow-up to the event reported on mm/dd/yy. You may submit as many follow-up reports as needed. Why this is important: suppose the information about this event suggests that the safety and welfare of other subjects is at risk. If you wait for the event to fully resolve you may place other subjects at risk. Promptly reporting the event allows the IRB to evaluate the safety of the research and determine if other subjects need to be informed of the event or even if the research needs to be suspended or terminated.
If the Adverse Event requires you to change your Informed Consent form (e.g. add new risks), you must a strike-out/underline version of any affected pages showing deletions/additions as well as an entire clean copy of the document (with all the changes fully implemented – no underline or strike-out showing). You do not need to include a revision memo – simply make sure that you answer “Yes” to question 11 on your Serious and Unexpected Adverse Event & Safety Report Form.
If your study is sponsored or conducted at multiple sites you may have an obligation to inform those parties about the event. You should confer with the appropriate outside parties (e.g. sponsor) about your obligations.
When working with our forms or other electronic protocol documents, you should save each with a name that identifies the file with this particular study and date that you submit this form. For example, let’s pretend our study is called “Use of drug xxx in patients with condition yyy”. You might name your files: xxx-IQ-062206, xxx-prot-062206, xxx-icf-062206, etc. Rather than using the drug name you could also use a sponsor protocol number, IRB number, etc. Naming files in this manner can be particularly useful (1) when searching for files on your computer, and (2) keeping track of different versions of the documents as they are revised. Thus, if I were submitting an adverse event for this project I could create the following new files:
- xxx-aer-060407 (the IRB Adverse Event form),
- xxx-icf-060407tc (revised Informed Consent form with track changes)
- xxx-icf-060407 (clean copy of the revised Informed Consent form, to be used as the basis for any future changes)
If additional follow-up reports are required, I could save the files as: