Pre-Action Protocol for Clinical Negligence: Letter of Claim Walkthrough

Last updated: 5 May 2026

Quick answer

The Pre-Action Protocol for the Resolution of Clinical Disputes requires a Letter of Claim sent to the defendant before issuing court proceedings. The letter sets out the alleged facts, the alleged negligence, the alleged injury, and the basis for damages. The defendant has four months to investigate and respond with a Letter of Response. Compliance with the Protocol is not optional — Civil Procedure Rules Part 3.1(4)–(5) gives the court power to penalise non-compliance with costs orders, adverse inferences, or refused permission to issue. Send the Letter of Claim with the supporting documents the Protocol expects, allow the four months, and only then issue proceedings.

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What the Protocol is for

The Pre-Action Protocol for the Resolution of Clinical Disputes (commonly called the "Clinical Negligence Protocol") is the framework for what the parties must do before clinical-negligence proceedings can be issued. It sits within the Civil Procedure Rules and is the gateway every claim has to go through.

The aim is straightforward: get the parties exchanging proper information early, narrow the issues, and resolve cases without going to court where possible. Roughly two-thirds of clinical-negligence claims settle before issue. The Protocol is the scaffolding for that.

The Protocol applies to:

• NHS Resolution claims (against NHS trusts and English GPs)
• Independent-sector claims (private hospitals, private consultants)
• Direct-claim defendants (community pharmacists, dental practices, paramedics in some scenarios)

It does not apply to mass-action and group-litigation claims, which have their own group-litigation orders.

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Before the Letter of Claim — what comes first

Before the Letter of Claim is sent, the Protocol expects you to have gathered the basics.

1. Letter of Notification (optional but recommended)

You can send a Letter of Notification to the defendant once you reasonably believe a claim is likely. It is short — half a page — and tells the defendant a claim is coming so they can preserve records and reserve.

NHS Resolution treats a Letter of Notification as a trigger for early ADR conversations in some cases. Worth sending if the timing is right.

2. Medical records request

Under UK GDPR Article 12(3) and the Data Protection Act 2018, the controller must respond to a Subject Access Request without undue delay and within one month of receipt — extendable by a further two months where the request is complex, with notification to the data subject within the first month. Records are free of charge unless the request is "manifestly unfounded or excessive" — in practice, medical records are nearly always supplied free.

You will usually want:

• Full GP records (paper and electronic)
• Hospital records — including imaging, reports, charts, drug charts, theatre notes, anaesthetic charts
• Out-of-hours service records if relevant
• Any other treating clinician's records (community nursing, mental health team)

Ask for everything in date order, with imaging on a separate USB or DVD.

3. Independent expert evidence

You should have a letter or short report from a suitably qualified independent expert before the Letter of Claim, confirming that:

• There is an arguable case on breach of duty
• There is an arguable case on causation

The Protocol does not require you to disclose the expert's report at this stage — but you must not send a Letter of Claim without one in your possession. Sending a Letter of Claim "to test the water" without expert support is the kind of conduct that attracts a costs penalty and a wasted-costs warning from the defendant's representatives.

4. Witness statements

Get the claimant's account in writing as a draft witness statement. It does not need to be in final form for the Letter of Claim, but the facts should be clear: who, what, when, where.

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Anatomy of a Letter of Claim

The Protocol prescribes the contents at paragraph 3.16. The Letter of Claim must include:

A. The claimant's identity

Full name, date of birth, address, NHS number where relevant. If there is a litigation friend, identify them and the basis on which they act (parent of a child, deputy under the Mental Capacity Act, etc.).

B. A clear summary of the facts

A chronological narrative of what happened. It does not need to be a witness statement — a tight three to five pages of fact is usually right. Include:

• The treatment relationship (GP appointment dates, hospital admission dates)
• The specific treatment events alleged to be negligent
• The clinicians involved (named where known)
• The injury suffered and when it became apparent

C. The main allegations of negligence

The "Bolam-Bolitho" case for breach of duty. State each alleged failure as a numbered allegation. Be specific.

A weak allegation reads: "The defendant failed to provide proper care."

A strong allegation reads: "On 12 March 2024 at 14:20, when the claimant attended the Emergency Department with chest pain radiating to the left arm and a heart rate of 130 bpm, the defendant failed to perform an electrocardiogram within 10 minutes of arrival, contrary to the NICE Quality Standard QS68 statement 1."

The latter ties the breach to a recognised standard. The former is too vague to investigate.

D. The alleged injury

What injury did the claimant suffer? Set out the diagnosis, the prognosis, the impact on day-to-day life, the impact on work, the financial losses incurred and projected.

E. Causation

The link between the alleged breach and the alleged injury. Causation is often the hardest element in clinical negligence. State the case on causation clearly:

• "But for" causation: the injury would not have happened but for the breach
• Material contribution: where multiple causes operated, the breach made a material contribution
• Loss of chance: rarely available in clinical negligence (Gregg v Scott [2005] UKHL 2), but sometimes argued

F. Documents you have considered

Listing the medical records, expert opinion summary (without disclosing the report itself), witness accounts, and any other evidence considered.

G. The remedy sought

Damages. Quantum is not usually pleaded in detail at this stage, but a "broad band" indication is helpful. Are you in a £30,000 claim, a £150,000 claim, or a £1.2 million catastrophic-injury claim? The defendant needs to know the size for reserving and ADR planning.

H. A request for a Letter of Response within four months

Refer to paragraph 3.21 of the Protocol. Confirm the date by which the response is expected.

I. Identity of the proposed defendant

For NHS hospital cases, this is usually the NHS trust. For GPs, it is the GP partner(s) or the practice if a limited company. For private consultants, it is the consultant personally and any private hospital that is jointly responsible.

NHS Resolution centralises the defendant function for English NHS trusts and GPs — send the letter to NHS Resolution at resolution.nhs.uk for the relevant trust/practice.

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Common Letter-of-Claim mistakes

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What the defendant does in the four months

The Protocol gives the defendant four months to investigate and respond. In that time NHS Resolution or the private-sector defendant will:

1. Acknowledge the Letter of Claim within 14 days
2. Pull the medical records
3. Take internal accounts from the clinicians involved
4. Instruct breach-of-duty and causation experts
5. Draft a Letter of Response

The response will either:

• Admit liability (rare in clinical-negligence — about 3-5% of NHS cases)
• Admit some allegations and deny others (more common — perhaps 20-25%)
• Deny liability in full (most common — about 70%)
• Make a Part 36 offer or other ADR proposal alongside

A denial does not end the matter. Many cases continue through Particulars of Claim, Defence, and exchange of expert evidence before settlement.

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What if the defendant does not respond?

If four months pass with no Letter of Response, you can issue proceedings without further delay. The Protocol's failure point is reached. The defendant cannot then complain about Protocol non-compliance, and the court is likely to grant relief from any procedural sanction the defendant raises.

You can also issue earlier than four months if:

• A Limitation Act 1980 deadline is approaching (issue protective proceedings; serve later)
• The claimant's prognosis is poor and quantum needs preserving
• A child claimant is approaching their 21st birthday (the limitation deadline expires on that date — see Clinical Negligence Time Limits)

If you issue early without those reasons, the court may stay proceedings to allow the Protocol to run its course.

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ADR within the Protocol

The Protocol expects parties to consider ADR throughout. Common ADR routes in clinical negligence:

• Round-table meetings — often booked for after exchange of expert evidence; settle a high proportion of cases
• Mediation — increasingly common; CEDR and Trust Mediation are established providers
• Joint settlement meetings — variation on round-table
• NHS Resolution mediation scheme — the centralised scheme for NHS cases

Refusing ADR without good reason can attract costs sanctions. Halsey v Milton Keynes General NHS Trust [2004] EWCA Civ 576 set the original framework on cost consequences of unreasonable refusal. The Court of Appeal in Churchill v Merthyr Tydfil County Borough Council [2023] EWCA Civ 1416 went further: the court can now lawfully order or stay proceedings to compel ADR, provided Article 6 rights are respected. Subsequent CPR amendments in 2024 (CPR Part 1 and Part 3 changes on ADR) reinforce this. Refusing reasonable ADR proposals is increasingly costly.

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How BundleCreator helps

Trial bundles in clinical negligence are voluminous. A multi-track clinical negligence trial bundle commonly runs to 1,500-3,000 pages across:

• Medical records (often the largest section, sometimes 1,000+ pages)
• Witness statements and exhibits
• Expert reports — breach of duty, causation, condition and prognosis, care, accommodation, deputyship
• Schedule of loss
• Counter-schedule
• Inter-expert correspondence and joint statements

CPR Part 32 and Part 35 set the format; the trial centre's specific directions cap individual document sizes. BundleCreator's Medical Negligence template structures the bundle in the order trial counsel expect:

• Section A: Pleadings and case management
• Section B: Witness evidence
• Section C: Medical records (chronologically arranged with hyperlinked tabs by treating clinician)
• Section D: Expert evidence (breach, causation, condition, care, accommodation, deputyship)
• Section E: Joint statements
• Section F: Quantum schedules
• Section G: Inter-party correspondence

Pagination, hyperlinked index, OCR, and bookmarks are produced automatically. A bundle that takes 8-12 hours to assemble manually is usually finished in under half an hour.

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Frequently asked questions

Can I send a Letter of Claim while the defendant is still investigating my complaint?

Yes. Complaints to the trust, the Parliamentary and Health Service Ombudsman, or the GMC are separate from Protocol litigation. Many claimants run both in parallel. The Letter of Claim formalises the legal route.

What if the records reveal a different defendant?

You may discover during records review that another clinician or organisation is the proper defendant. Send the Letter of Claim to the correct defendant once you know. If you have already sent it to the wrong defendant in good faith, the court will not normally hold this against you.

Do I need a solicitor?

No. The Protocol is designed to be navigable by a litigant in person, and many simple cases run without a solicitor. But clinical negligence is technically demanding, expert evidence is expensive, and quantum is hard to assess. Most claimants instruct a specialist clinical-negligence solicitor on a Conditional Fee Agreement (no win, no fee).

What if the defendant offers settlement during the four months?

Consider it. A defendant making an early offer is signalling concern about the merits or quantum. Compare against your expert's view of value, take advice if you have it, and respond. Negotiation can be informal at this stage; an offer can be accepted or made into a formal Part 36 offer once proceedings are issued.

What does "Bolam-Bolitho" mean?

The two-stage test for breach of duty. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582: a doctor is not negligent if they acted in accordance with a practice accepted as proper by a responsible body of medical opinion. Bolitho v City and Hackney Health Authority [1998] AC 232: the body of medical opinion relied on must itself be capable of withstanding logical analysis. The two together set the modern test.

How much does a Letter of Claim cost to prepare?

For a solicitor on a CFA, the cost is rolled up in the success fee and recoverable from the defendant if the claim succeeds. For a litigant in person, the costs are an expert's letter (typically £750-£2,000) and your own time.

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Further reading

• Pre-Action Protocol for the Resolution of Clinical Disputes — Official Protocol text
• Civil Procedure Rules Part 3 — Court's case management powers
• NHS Resolution — The defendant for English NHS clinical negligence
• Clinical Negligence Time Limits: The 3-Year Rule and the Date of Knowledge
• Clinical Negligence Expert Evidence: Breach of Duty vs Causation Reports