Clinical trial meaning

Checklist This Checklist summarises the potential claims against a defendant where the claimant in a personal injury case has died before trial. It reviews the principal statutory regimes—the Law Reform (Miscellaneous Provisions) Act 1934 (LR(MP)A 1934) and the Fatal Accidents Act 1976 (FAA 1976)—and indicates who may bring the claim and the recoverable heads of loss. For further guidance, see Practice Notes: Law Reform Act or Fatal Accidents Act? and Claims involving a fatality—heads of damage... Cause of action Claim on behalf of the deceased’s estate (under LR(MP)A 1934) Who can bring the claim? By the administrator or executor of the estate. A valid will or Grant of Letters of Administration will be required... Heads of loss Guidance on the recoverable heads of loss is provided by LR(MP)A 1934 and FAA 1976 and in the referenced Practice Notes...

This Checklist This Checklist helps pinpoint typical recoverable historic financial outgoings and losses (special damages or historic pecuniary losses) arising before trial. It also aids in collating suitable evidence and highlights the questions that commonly emerge when valuing these losses, setting out recurring issues for consideration as appropriate in practice. For additional guidance, see: Past expenses and losses—overview...

Checklist This Checklist sets out the practical actions for creating, drafting and quality-checking a Participant Information Sheet (PIS) for UK clinical research. It describes what the PIS is for and how it works, and gives hands-on advice on the essential components, addressing content and presentation alongside layout, format and style. The Checklist also explains how the PIS should meet obligations under UK data protection law, including the transparency duties in the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR). It is suitable for any study involving human participants, with particular emphasis on clinical trials of investigational medicinal products (CTIMPs). A clinical trial is a study in human subjects intended to identify or confirm the effects of an adverse reaction to a medicinal product. In the UK, such trials are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (MHU(CT)R 2004), SI 2004/1031, which transposed EU Directive 2001/20/EC, the Clinical Trial Directive (CTD), into domestic law. These rules create a legal framework designed to...

Johnstone v Fawcett’s Garage (Newbury) Ltd [2025] EWCA Civ 467 What are the practical implications of this case? The key consequence of the ruling is the Court of Appeal’s categorical and wholesale dismissal of the ‘absolute risk approach’, put forward by the defendant in this case on the strength of obiter support from the High Court in Bannister v Freemans Public Ltd Company [2020] EWHC 1256 (QB). As a consequence of the Court of Appeal’s decision in this case, those obiter remarks in Bannister should no longer be regarded as representing good law, or treated as authoritative. The judgment further confirms that it was open to the trial judge in this case to employ a ‘direct risk assessment’ to calculate the increase in the risk of a person developing mesothelioma, and that doing so was permissible on the facts. It does not, however, set a general principle that this technique is valid or appropriate in all comparable matters involving low doses of exposure, although the court’s acceptance of...

In this issue: Post-market Intellectual property Pharmaceuticals—regulatory framework Research and development Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Post-market What’s next for UK product liability? Andrew Austin, partner; Harriet Hanks, counsel; and Rachel Duffy, senior associate at Freshfields LLP, examine the UK Law Commission’s review of the domestic product liability framework for defective goods, with a particular lens on emerging technologies such as artificial intelligence, and set against notable recent developments in the EU. See News Analysis: What’s next for UK product liability? EMA updates pharmacovigilance requirements and ends EudraVigilance pilot phase The European Medicines Agency (EMA) has released guidance following adoption of Commission Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012. This change formally concludes the EudraVigilance signal detection pilot for Marketing Authorisation Holders (MAHs), and requires all MAHs with authorised medicinal products in the EEA, including Northern Ireland, to monitor EudraVigilance...

In this issue: Key PI and Clinical negligence developments Noise-induced hearing loss Abuse and criminal injuries Coroner’s inquests New content LexisNexis® PI & Clinical Negligence Quantum Database LexisNexis® Quantum Portal LexTalk®PI & Clinical Negligence: a Lexis®Nexis community Daily and weekly news alerts LexisNexis® Webinars Useful information Key PI and Clinical negligence developments HMCTS issues form for out-of-hours applications to the Court of Appeal (Civil Division). HM Courts & Tribunals Service (HMCTS) has released a mandatory form to be used when applying out of hours in the Court of Appeal (Civil Division). See: LNB News 08/10/2025 40. Noise-induced hearing loss MoD hearing loss trial may shape broader claims. Law360, London: On 6 October 2025, thousands of former service personnel returned to court seeking damages for noise-related hearing impairment sustained during military service, in proceedings that could carry significant consequences for other military and civilian hearing loss actions. See News Analysis:...

ARCHIVED: This Practice Note is archived and no longer updated. It is retained solely for historical context, as it outlines CPR Part 36 as it stood before 6 April 2015. If you have received, or are proposing, a Part 36 offer on or after 6 April 2015, you should consult the CPR 36 currently in force together with the relevant Practice Notes and Precedents. See Practice Note: Part 36 offers in PI and clinical negligence claims and Part 36 offers—overview. Where a Part 36 offer was made or received before 6 April 2015, the pre‑6 April 2015 Part 36 regime continues to apply. A copy of the pre‑6 April 2015 Part 36 rules can be accessed here: If a Part 36 offer predates 6 April 2015 but any trial of part of the claim, or any issue within it, is listed to begin on or after 6 April 2015, you will need to consider the new CPR 36 in relation to acceptance, disclosure, and definitions...

Fixed recoverable costs in noise-induced hearing loss (NIHL) claims Following recommendations of the Civil Justice Council, fixed recoverable costs for NIHL matters were introduced. The principal provisions are located in: Pre-Action Protocol for Disease and Illness Claims, Annex E Section VIII of CPR 45 Table 15 of CPR PD 45 Annex E of the Pre-Action Protocol for Disease and Illness Claims Scope Annex E to the Pre-Action Protocol for Disease and Illness Claims applies where: the claim concerns NIHL the claim appears suitable for allocation to the fast track the first letter of claim is issued on or after 1 October 2023 Annex E is designed to underpin the fixed recoverable costs regime set out in Section VIII of CPR 45. If there is any inconsistency between the general provisions of the Pre-Action Protocol for Disease and Illness Claims and Annex E, Annex E takes priority. Excluded cases The...

Directive 2001/83/EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation (MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all. Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection (RDP). This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering innovative medicinal products and considers how those rules affect the timing of market entry for generic and biosimilar medicines. It further outlines how RDP is addressed in the...

Schedule of loss & dependency in a fatal accident claim [ IN THE COUNTY COURT AT [ INSERT ] OR IN THE HIGH COURT OF JUSTICE ] [ [ Specify division ] ] [ [ Insert location ] DISTRICT REGISTRY ] Claim No: Between AB, Claimant (the Widow and Executrix of the estate of A, deceased) and C Limited, Defendant Note On 2 December 2024 the Lord Chancellor confirmed that the discount rate would move to a positive 0.5%. That positive 0.5% rate takes effect from 11 January 2025. Under Schedule A1 to the Damages Act 1996, later reviews must occur within five years of the end of the previous review, meaning the next review must begin on or before 2 December 2029. The Claimant retains the right to revise, modify or supplement this schedule at any time up to and including trial...

[ AT THE COUNTY COURT AT [ INSERT ] OR IN THE HIGH COURT OF JUSTICE ] [ [ SPECIFY DIVISION ] ] [ DISTRICT REGISTRY AT [ INSERT LOCATION ] ] Claim No: Between [ Insert name ] Claimant and [ Insert name ] Defendant ________________________________________________ SCHEDULE OF LOSS CALCULATED TO [ INSERT DATE OR INSERT THE DATE OF TRIAL ] ________________________________________________ Note On 2 December 2024, the Lord Chancellor declared that the discount rate would move to positive 0.5%. This positive 0.5% rate comes into effect on 11 January 2025. Schedule A1 to the Damages Act 1996 stipulates that later reviews are to occur within five years of the end of the preceding review, which means the next review must start on or before 2 December 2029. The Claimant reserves the ability to revise, amend, or supplement this schedule at any point up to and including trial. A....

[ IN THE COUNTY COURT AT [ INSERT ] OR IN THE HIGH COURT OF JUSTICE ] [ [ SPECIFY DIVISION ] ] [ [ SPECIFY SPECIALIST COURT ] ] [ [ INSERT LOCATION ] DISTRICT REGISTRY ] Claim No: Between [ A B ] Claimant and [ X Y ] Defendant ______________________________________________ COUNTER SCHEDULE OF LOSS ______________________________________________ The Defendant retains the right to vary, revise or supplement this Counter Schedule of Loss at any time up to and including the trial. PAST LOSSES 1 Previous loss of earnings (i) Loss of earnings to [ insert date eg 26 February 2019 ] are accepted in the pleaded claim at £[ insert amount ]. (ii)–(iii) Loss for the period [ insert date eg 26 February 2019 ] to [ insert date eg 25 August 2019 ] is not admitted. As a matter of principle, the Defendant accepts that it may take time to secure work of equivalent remuneration. However, the Claimant’s evidence does...