Pharmacovigilance and Safety Reporting
The Medicines for Human Use (Clinical Trials) Regulations set out specific requirements for the recording and reporting of adverse medical occurances effecting clinical trial patients - refered to as Pharmacovigilance.
Different types of Pharmacovigilance events are subject to different reporting requirements. It is vital that this Policy is followed as failure to report incidents, or deal with incidents adequately, can have the potential to jeopardise the safety and well-being of trial subjects.
In short:
- All medical occurences must be recorded in the patient's medical records, assessed for their relationship to study treatments or procedures and recorded in the study case report form for the patient - as Adverse Events or, if related, Adverse Reactions.
- Occurences that -
- result in death,
- are life threatening,
- require or prolong hospitalisation,
- result in persistent or significant disability or incapacity or
- consist of a congenital anomaly or birth defect
are Serious Adverse Events or Reactions (SAEs/SARs) which must be recorded as above and reported immediately to the study sponsor (KHPCTO in the case of studies sponsored by one or more of the Partner Organisations).
- All SARs will be further assessed to determine whether they have previously been reported in the Reference Safety Information for the product/procedure. If the nature or severity of a reaction is not currently listed in the RSI, it is a Suspected Unexpected Serious Adverse Reaction (SUSAR). - These events are described as 'Suspected' as they require further reporting to and investigation by the CI, Sponsor, REC and MHRA.
Policy: Pharmacovigilance & Safety Reporting (310KB)
Related Documentation
Serious Adverse Event Reporting Form (300KB)
Serious Adverse Event Form Completion Guideline V3.1(350KB)
Useful Links
Health Research Authority - Safety Reporting Processes
MHRA guidance on Safety Reporting
