The following Life Sciences practice note provides comprehensive and up to date legal information covering:
A clinical trial is an investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie it assesses a medicine’s efficacy and safety. In the UK and the EU, clinical trials must be conducted on new medicinal products before they can receive approval to be placed on the market, but clinical trials are also conducted on medicinal products which are already available to the public in order to demonstrate their efficacy compared to competing products or placebos. For more information on marketing authorisations (MAs), see Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products.
The safety and protection of the human subjects is of paramount importance. Clinical trials on humans must be justified and can only take place after the long and detailed preclinical research process has concluded and the clinical trial has received the necessary authorisation.
A clinical trial may show that a new medicinal product improves patient outcomes, offers no therapeutic benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care. Due to the complex nature of clinical trials they usually last at least one year, generally involve numerous participants and several trial sites, often in different countries.
**Trials are provided to all LexisPSL and LexisLibrary content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. To discuss trialling these LexisPSL services please email customer service via our online form. Free trials are only available to individuals based in the UK. We may terminate this trial at any time or decide not to give a trial, for any reason. Trial includes one question to LexisAsk during the length of the trial.
To view the latest version of this document and thousands of others like it, sign-in to LexisPSL or register for a free trial.
Existing user? Sign-in
Take a free trial
What is rescission of a contract?The remedy of rescission is available to a party whose consent, in entering into a contract, has been invalidated in some way:•the effect of rescinding a contract is to extinguish it and restore the parties to their pre-contractual positions•the main grounds of
ContractWhere a contract is made by two or more parties it may contain a promise or obligation made by two or more of those parties. Any such promise may be:•joint•several, or•joint and severalWhether an undertaking is joint, several, or joint and several in contract is a question of construction
Source of the doctrine of the separation of powersThe origins of the doctrine are often traced to John Locke’s Second Treatise of Government (1689), in which he identified the 'executive' and 'legislative' powers as needing to be separate.‘… it may be too great a temptation to human frailty, apt to
This practice note provides an introduction to tort law by addressing three questions:•what does the concept of being liable in tort mean? And how does tort relate to contract and criminal law•how has the law of tort developed?•what is the scope of tort, ie what interests does it protect? What
0330 161 1234
To view our latest legal guidance content,sign-in to Lexis®PSL or register for a free trial.