Terms of Use & AI Notice

Please read this before using SOPMaker. By logging in and generating a pack you accept these terms. The key points are repeated on screen, and you must tick to confirm them before you can download your pack.

Last updated: 2 July 2026 · Provider: Primary Care Research Alliance (PCRA) · Contact: daphne@pcralliance.uk

1. What SOPMaker is — and is not

It is a tool that produces a draft, starting-point pack of clinical-trial Standard Operating Procedures, tailored to the answers you give about your organisation.

It is not a finished, validated or approved set of SOPs. It does not replace your own quality review, your professional judgement, your sponsor's protocol or lab manual, or your organisation's sign-off process.

2. The content is AI-assisted

Every SOP is rendered from PCRA's reviewed, version-controlled templates, which were drafted with the assistance of an artificial-intelligence model (Anthropic's Claude) and then human-reviewed. The accompanying extras — the one-page quick-reference cards, the pack coherence review and any pack-scope suggestions — are drafted by the AI model at generation time. AI-assisted text can contain mistakes, omissions or statements that are out of date or do not fit your local context, even when it reads convincingly. PCRA applies automated quality, consistency and regulatory checks, but these reduce — they do not remove — the need for you to read and check every document.

3. Your responsibilities before using a pack

You agree that, before adopting, signing or relying on any SOP in the pack, you will:

1. Read every SOP in full and confirm the roles, equipment, systems, contacts, premises and procedures match your organisation.
2. Check regulatory accuracy and currency against the current Medicines for Human Use (Clinical Trials) Regulations, ICH GCP E6(R3), and your sponsor's requirements.
3. Complete any gaps flagged in the pack and populate the controlled records the SOPs refer to.
4. Have the Principal Investigator / appropriate authority review, approve and sign each SOP before it is used.
5. File and retain the signed SOPs in line with your obligations (25-year retention for CTIMP records).

4. Do not enter patient data

SOPMaker is for organisational and professional information only. Do not type any patient-identifiable information, trial-participant data, or special-category (health, etc.) data into the questionnaire. The form does not ask for it and does not need it.

5. Access and acceptable use

• Access is by a per-organisation access code issued by PCRA (no individual accounts — no personal login data is stored). Do not share your organisation's code beyond those authorised; codes carry a use-quota and can be revoked and reissued.
• Use the tool only for its intended purpose — generating SOP drafts for a bona fide UK NHS-facing research organisation.
• Do not attempt to overload, probe, reverse-engineer or misuse the service.

6. No warranty; limitation of responsibility

SOPMaker is provided in good faith to help your readiness, "as is" and without warranty that the output is complete, accurate, current or fit for a particular study or purpose. To the extent permitted by law, PCRA is not responsible for any loss arising from use of an SOP that has not been independently reviewed and approved by your organisation. Final responsibility for every SOP you adopt rests with your organisation and its accountable individuals. Nothing in these terms limits any liability that cannot be limited in law.

7. Privacy

How your data is handled is set out in the Privacy Notice. In short: only professional staff details are processed, no patient data, EU hosting, AI drafting in the US under Standard Contractual Clauses + the UK Addendum (Anthropic's DPA), and automatic deletion within 24 hours.

8. Complaints

If something goes wrong or you are unhappy with the service or how your data was handled, our Complaints Procedure explains how to raise it. You also have the right to complain to the Information Commissioner's Office (ico.org.uk).

9. Changes

We update these terms when the tool changes meaningfully. The date above shows the last revision.