Adverse event FAQ

Find answers to frequently asked questions relating to adverse events on this page.

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Q1: How do I report an Adverse Event (AE), or a Serious Adverse Event (SAE) such as death? / How do I add an Event of Special Interest form to the database?
Q2: How do I report a death if I have not had contact with the patient since their last follow up/have no further information about the death?
Q3: What if the date of death is unavailable to me?
Q4: Can I just complete the Adverse Events section of the follow up record if I have no information about the patient’s Biologic targeted therapy/Other current therapy/Disease activity?

Q1: How do I report an Adverse Event (AE), or a Serious Adverse Event (SAE) such as death? / How do I add an Event of Special Interest form to the database?

For all of our information on Adverse Events and Serious Adverse Events, please see the following document on our database tutorials page:

Recording an AE or SAE / Adding an ESI form

Q2: How do I report a death if I have not had contact with the patient since their last follow up/have no further information about the death?

In these instances, we still require the death to be reported as a serious adverse event in the current follow up record in order that the event can be processed correctly in the database. In the ‘Detailed description of the event’ box in the Adverse Events section of the follow up record, please make a note that no further details are available, so that our team do not continue to ask you for additional information. If a follow up record is not currently open for you to report this information, please contact the BSRBR-RA Team and they will open a follow up record for you.

Q3: What if the date of death is unavailable to me?

We would ask you to estimate the date of death and select the tick box that says ‘This is an estimated date’.

Q4: Can I just complete the Adverse Events section of the follow up record if I have no information about the patient’s Biologic targeted therapy/Other current therapy/Disease activity?

We ask that you complete all sections of the follow up record to the best of your knowledge (e.g. as far as you are aware the patient has not started a new biologic targeted therapy since the last follow up was completed). Please add a note in ‘Feedback’ to advise the BSRBR-RA Team that you have completed as much data as possible in the follow up record.

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