Reporting adverse events in clinical trials is critical for patients’ safety and drug profile. Majority of the clinical trials nowadays use electronic adverse events reporting.
In order adverse event to be considered serious it should meet one of the following criteria:
  1. Death – Please note in some clinical trials “death” may not considered SAE.
  2. Life-threatening
  3. Hospitalization (initial or prolonged) – Please note in some studies initial hospitalization may not be considered SAE.
  4. Disability or Permanent Damage
  5. Congenital Anomaly/Birth Defect
  6. Required Intervention to Prevent Permanent Impairment or Damage (Devices)
  7. Other Serious (Important Medical Events)
Usually SAEs have to be reported to the Sponsors within 24 hours after clinical trials team discovers the event. This, of course, leads to some complications because team members could be on annual leave, sick leave, attending conference, etc. If there is no back-up from the research team usually a hospital staff member could report SAE using paper form if they don’t have access to CRF.
Imagine you do not work on a clinical trial but you have learnt that one of the patients have had adverse event that meets the SAE reporting criteria. What do you need to report as minimum to the Sponsor?
  1. Patient identification – You have to use patient clinical trial number. Please remember never to include patient name, hospital number or any patient personal details.
  2. Adverse Event term
  • Don’t report procedures (colonoscopy, CT head, fistula surgery, etc.) as SAE because safety team that reviews all SAEs needs to know the actual or suspected diagnosis.
  • If you don’t know the diagnosis, write down suspected diagnosis. Event term could always be changed when additional information is available. No need to wait for final diagnosis to report SAE.
  • Don’t report lab results (elevated glucose, low Hb, etc.) as SAE term and always use the underlining condition, which caused abnormal lab results.
  1. Start date of the SAE – this is usually the date when the existing adverse event became serious or in case of hospitalization – the date of admission.
  2. Severity of the SAE – serious, moderate or mild.
  3. Reporter – the name and contact details of the person who reports the SAE. This is in case safety team has to contact you for additional information.
  4. Study drug – any available information about study drug like dose, last time taken, how long the patient was on medication, etc.
Please remember that the reported SAE could always be updated when new information is available. There is no need to have all details to report SAE but the 6 points above are highly recommended for initial reporting.
Published on 15 September 2015
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe