Adverse events The definitions are as follows :
adverse event (AE): any untoward medical occurrence in the patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 'Adverse Reaction' (AR): any untoward and unintended response to an investigational medicinal product related to any dose administered 'Unexpected Adverse Reaction' (UAR): an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator's Brochure for an unauthorized investigational product or summery of product characteristics for an authorized product) 'Serious Adverse Event' (SAE) or serious adverse reaction (SAR): an untoward medical occurrence or affect that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or is a congenital anomaly or birth defect.
Registration and reporting:
As a rule, all adverse events shall be registered in a clinical trial on medicinal drugs. However, there may be some exceptions for a variety of reasons, where it is required to waive this requirement. The protocol shall indicate which procedures are required to be followed, in relation to the registration and reporting and, in particular, what is not needed to be reported.
Reference Safety Information:
The reference safety information (RSI) is used to assess whether a serious adverse reaction (SAR) is considered to be expected or unexpected. For approved medicinal products, it will typically be the Summary of Product Characteristics (SmPC) (section 4.8), if the medicinal product is used within the approved indication. For medicines under development, it will be a section / table in Investigator's Brochure (IB). Sponsor must choose an SmPC, which is used to assess the safety of subjects in the trial. This SmPC will be the RSI during the trial at all sites. Prior to initiation of the trial, sponsor must submit the correct RSI to all sites, and it must be clearly stated when the document was approved. This date is the version number of the RSI. If the RSI is changed, it must be submitted to the Danish Medicines Agency as a significant change, unless submitted at the same time as the annual safety report. The RSI shall not be submitted to the Scientific Ethics Committee. If a new RSI is approved, the sponsor must forward the new RSI to all sites.