Serious Adverse Events
Definition
Serious Adverse Event (SAE)
A serious adverse medical event concerning a patient or subject that is not necessarily causally related to treatment and is
- fatal, and/or
- endangers the subject's life, and/or
- makes hospitalisation or prolongation of hospitalisation necessary, and/or
- causes persistent or significant disability or incapacity, and/or
- manifests itself as a congenital anomaly or malformation.
Serious Adverse Reaction (SAR)
Probability that the serious adverse event (SAE) is a damaging and undesired reaction to the investigational drug, regardless of the administered dose.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
More information
- Act on experiments on human beings of 7 May 2004 arts 28
- Circular no. 586
Responsibility
The EC points out that it is primarily the sponsor and investigators' responsibility to evaluate serious adverse events and to take the necessary action (e.g. amendment, modification of patient information).
The investigator immediately reports all SAEs to the sponsor, except when it relates to serious adverse events for which, according to the protocol or the investigator's file no immediate reporting is required.
Generally, the following rules apply in relation to reporting a death during a study covered by the Act on experiments on human beings of 7 May 2004:
- The investigator provides the sponsor and the recognised central ethics committee with all initial and any additional information about deaths.
- If it concerns a death of a patient at UZ Leuven, the investigator should always inform the EC Research, even if the committee for the study in question acts as a local committee.
The aforementioned rules on reporting a death apply to all prospective studies. The act makes no distinction between a death occurring in a non-interventional study and an interventional study.
However, the EC Research wants a pragmatic approach to the reporting of deaths in observational registry studies that are not linked to a drug and/or device. In these registry studies, deaths should not be reported to the EC. For observational studies with a link to a drug and/or device (i.e. safety and efficacy registers), the general rules as specified above do apply.
The EC expects the S-number of the study, the code number of the patient, the cause of death and whether or not the death is related to the study to be reported by email. Please do not pass on the full name of the deceased to us.
The sponsor shall ensure that all relevant information on SUSARs that led or may lead to the death of a participant is recorded and reported to the competent ethics committee as soon as possible, in any case no later than seven days after the sponsor learns of the case, and that relevant information on their consequences is subsequently communicated within a further eight days.
All other SUSARs shall be reported to the relevant ethics committee as soon as possible, no later than 15 days after the sponsor was first informed of them.
How does it need to be submitted?
All documents must be submitted electronically. Follow the procedure.
Practical guidelines regarding proof of receipt
The EC Research provides proof of receipt when:
- EC Research acts as central (leading) ethics committee for the relevant study
- it concerns a death and EC Research is acting as local ethics committee
Please state to whom proof of receipt/notification should be sent (email address preferably to the investigator or study nurse/secretary within the hospital).
If it concerns unblinded data that should not reach the investigator, this should be clearly stated in a cover letter (with the addition of the email address of the contact of the sponsor to which proof of receipt should be sent).
Protocol violations
All protocol violations/deviations must be reported to the central ethics committee.
Any (possible) endangering of the safety of a patient must be reported immediately.
If patient safety was not (possibly) endangered, an annual report of these protocol violations/deviations (together with the annual progress report) is sufficient.