Adverse event reporting (2)

How to report adverse events to the ethics committee?

Serious adverse events (SAE)

Any adverse event that is classified as ‘serious’ should be reported to the ethics committee as quickly as possible, regardless of the cause.*

The initial SAE report may not need to provide a full account of the incident, but should at least include: ⁽²⁰⁾

• an identifiable subject (e.g. quoting the subject’s research ID)
• an identifiable reporting source (e.g. emergency department), and
• an outcome that is deemed as serious. 

Follow-up SAE reports should be submitted until the event is resolved, providing further details about the incident, the subject’s medical and drug history, investigation findings, treatments provided and the final outcome. Where a research procedure or intervention is suspected to have caused the incident, it should be fully described. ⁽²¹⁾

Suspected Unexpected Serious Adverse Reaction (SUSAR)

In multi-centre studies, AEs that have occurred at a different institution may still need to be reported to your local ethics committee if they are: i) serious, ii) unexpected and iii) possibly related to a research intervention that is also being used at your own study site.

When such AE is related to an investigational drug, it is reported as a ‘SUSAR’ (Suspected Unexpected Serious Adverse (drug) Reaction). 

How soon should they be reported?

Type of SAE / SUSAR	Initial report	Follow-up report
Fatal or life threatening	as soon as possible but no later than 7 calendar days from the awareness of the event	complete follow-up report within 8 additional calendar days
All other SAE or SUSARs	as soon as possible but no later than 15 calendar days from the awareness of the event	submitted as further information becomes available

Quoted from: UMMC MREC SOP III: Post approval review and Malaysian Guideline for Safety Reporting of Investigational Products (NPRA, 2014) ^{(15, 20)}

What will the ethics committee do with the report?

SAE reports will be screened and subjected to either a regular board meeting or an urgent special meeting. Special meetings are called for matters of life and death, public emergencies, sudden multiple occurrences of unexpected SAEs and the like. 

What are the possible outcomes?

The ethics committee may suggest no further actions, recommend corrective and preventive actions, suspend ethics approval pending further investigations; or terminate approval when there are serious safety concerns.

Where clarification is needed, you may be asked to submit further documents, or invited to attend another meeting.

What should you do after making the report?

You should continue to monitor the subject and other subjects for further complications. At all times, you should offer support to the subject(s) and/or their family, keep them well-informed and take their concerns seriously.

You and your research team should also reflect on the event and take prompt corrective / preventive actions where indicated. The occurrence of any unintended serious incidents to research subjects could be a very upsetting experience to everyone. It is important to support each other and seek help if needed.

Who else do you need to report to?

You may need to inform all subjects about any unanticipated adverse events that could be related to your research procedures. Non-serious adverse events or adverse reactions could still be important for subjects to know if they might impact on subjects’ quality of life (e.g. hair loss or impotence).  

For sponsored research, you should refer to your research protocol or clinical trial agreement for your sponsor’s adverse event reporting requirements.

For drug trials, refer to the Malaysian Guideline for Safety Reporting of Investigational Products (NPRA, 2014) for NPRA reporting requirements. ⁽²⁰⁾

For research using unregistered medical device, refer to the Medical Device Guidance Document (MDA, 2017) for MDA reporting requirements. ⁽¹³⁾