An Adverse Event (AE) is any untoward (unfavorable) or adverse medical occurrence in a patient or clinical investigation subject who is administered a medicinal product regardless of whether there is a causal relationship with the treatment or product.
An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, regardless of whether considered related to, or caused by, the medicinal product.
Regardless of whether the AE is thought to be caused or not caused by our product – all AEs must be reported.
Fair market value (FMV) states that payment to physicians and investigators should be based on a legitimate business relationship that provides identifiable value to the company and not just an opportunity to influence prescribers.
A healthcare provider is an individual, institution, or entity that, in the course of their professional activity, may prescribe, supply, administer, purchase or acquire or recommend a medicine, or influence any of the foregoing. Some common examples include doctors, nurses, hospitals, and health services.
Patient advocacy groups help patients, their families, and their caregivers navigate the hard times of illness. These groups work to ensure patients receive appropriate and timely care, education, and sometimes financial assistance, when needed.
Pseudonymised data is data where some of the key information, like patient name, is replaced with a unique numerical identifier. This helps to mask personal information.
The Bribery Act 2010 is an Act of the Parliament of the United Kingdom that covers the criminal law relating to bribery. Breach of the Bribery Act 2010 can lead to criminal sanction for both companies and individuals.
The US Federal Anti-Kickback Statute is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal healthcare program business.
This content is an extract from the Enviromenttal Health and safety booklet.