Compliance with the regulations | Event and incident reporting

Event and incident reporting

Adverse events and incidents occur in research projects and it is important that these events are reported correctly. The Trust and Queen Mary University of London (QMUL) are taking on the role of research sponsor and therefore are required to collect information regarding events that occur within research projects they are sponsoring or that affect their patients or staff.

An example of an adverse incident within a research project may be a situation where a patient falls and is injured during a research consultation or a situation where a patient becomes violent towards a staff member during a research project. These incidents should be reported using the Trust incident form available in all Trust departments.

There are different reporting requirements for research projects involving medicines, in particular clinical trials of medicines where legal requirements for reporting events have been introduced. You can make use of the flowchart below to help you decide what kind of adverse event has occurred in your research project and also to decide how you should report that event.

Download SAE Reporting Flowchart.

Reporting adverse events in clinical trials

If you are involved in a clinical trial of a medicinal product(s) and either the Trust or QMUL are sponsoring the trial you are required to inform the sponsor, as soon as possible of serious adverse events (SAEs) reported to you by trial participants. Sponsors are required by law to comply with their pharmacovigilance responsibilities and make arrangements to record, notify, assess, report, analyse and manage adverse events in trials they are sponsoring.

The Clinical Trials Regulations distinguish between adverse events, serious adverse events (SAEs), serious adverse reactions (SARs) and suspected unexpected serious adverse reactions (SUSARs). Serious Adverse Events are defined by Good Clinical Practice definitions as any untoward medical occurrence resulting in:

Death
A life threatening situation
In-patient hospitalisation or the extension of the period of hospitalisation.
Significant and/or persistent disability or incapacity, or
A congenital abnormality or birth defect.

If an incident is anticipated or likely as a result of the study population or condition, it can be excluded from the SAE reporting process only if it is clearly identified as a likely outcome in the study protocol. You will also need to assess if the SAE is linked to the medicine used in the trial as this will be classified as a Serious Adverse Reaction.

The trial sponsor must be notified of SAEs immediately and have systems in place to ensure that they are assessed for:

causality (is it a reaction to a trial medicine or not?) and
expectedness (is the reaction a recognised adverse effect of the medication or is it unexpected?)

Sponsors have to make sure that SUSARs are reported promptly to both the regulatory authorities (MHRA) and the relevant Ethics Committee. The Regulations set time limits:

Fatal or life threatening SUSARs: not later than 7 days after the sponsor for pharmacovigilance had information that the case fulfilled the criteria for a fatal or life threatening SUSAR, and any follow up information within a further 8 days.

All other SUSARs: not later than 15 days after the sponsor for pharmacovigilance had information that the case fulfilled the criteria for a SUSAR.

An annual safety report on all Serious Adverse Reactions (including SUSARs) must also be sent to the regulatory authorities and relevant Ethics Committee.

Reporting adverse events to the Joint R&D Office

A form has been developed which should be used to report SAEs to the JRMO for trials which Trust or QMUL are sponsoring.

Download Adverse Event Reporting Form.

If an SAE occurs during a trial, the Principal/Chief Investigator should asses whether the event is an SAE or a SUSAR and indicate this on the reporting form.

Completed Adverse Event Reporting Forms should be emailed to ResearchSafety@bartsandthelondon.nhs.uk, marked for the attention of the Research Governance and GCP Manager as soon as possible. A copy must also be sent to the ethics committee.

Faxes to report SAEs or SUSARs will not normally be accepted as due notification, unless email systems are down and prior contact has been made with a member of the GCP Team to inform them of this and to expect the fax.

If the Trust or QMUL are not the sponsor of your study you can either email an Adverse Event Reporting Form to us at ResearchSafety@bartsandthelondon.nhs.uk, marked for the attention of the Research Governance and GCP Manager, or fax it to us on 020 7882 7276.

More information

If you require further information, please contact a member if the GCP Team.