Clinical trials toolkit: Trial Supply

This Trial Supplies guide is written for researchers who need to turn complex investigational medicinal product (IMP) rules into practical, workable plans. It brings together, in one place, the key questions, common pitfalls and concrete actions that shape safe, efficient drug supply in publicly funded clinical trials. By walking through risk‑adapted approaches, manufacturing and import requirements, labelling, pharmacy roles, costing and documentation, it helps teams spot problems early and design solutions before they affect patients, timelines or budgets. The clear section structure, checklists and real‑world focus make it a useful starting point for anyone who feels less confident about IMP logistics but still carries ultimate responsibility for getting the right medication, to the right participant, at the right time.
It covers:

Common IMP challenges
Highlights typical IMP‑related issues across protocol development, set‑up and implementation, and their consequences for design, timelines, costs and patient safety.

Trial supplies checklist
Structured checklist of key questions on regulation, product choice, manufacture, documentation, storage, distribution and costs to support early planning of trial supplies.

EU and UK regulations governing IMPs
Summary of core European and UK clinical trials legislation and guidance for IMPs, including good clinical practice and good manufacturing practice requirements.

Manufacture of investigational medicinal products
Guidance on whether a study is a clinical trial of a medicinal product, IMP versus non‑investigational medicinal product classification and when manufacture under a Manufacturer’s Authorisation for IMPs is required.

Technical agreements
Outlines the purpose and essential content of technical agreements between sponsors and IMP manufacturers, with examples of common deficiencies.

Stability testing of IMPs
Explains when and why stability data are needed, the main types of stability studies and their role in setting shelf‑life and budgeting.

Investigational medicinal product dossiers
Describes what an Investigational Medicinal Product Dossier contains, how it supports clinical trial applications and when full, simplified or Summary of Product Characteristics‑based dossiers are used.

Imports of IMPs from non‑EU/European Economic Area countries
Summarises requirements for EU‑equivalent good manufacturing practice, Qualified Person import certification and declaration, and typical import‑related issues.

Advanced therapy investigational medicinal products
Points to specific guidance and responsibilities for clinical trials involving advanced therapy medicinal products.

Labelling of investigational medicinal products
Covers labelling requirements for IMPs, marketed products and non‑investigational medicinal products, including where labelling takes place and when post‑certification relabelling is possible.

Checklist for IMP‑related documents
Checklist of key IMP‑related agreements, regulatory approvals, Qualified Person and manufacturing documents and pharmacy records for the Trial Master File.

Checklist of manufacturing costs for trial supplies
List of common manufacturing and supply‑chain cost items to support budgeting and comparison of quotations.

VAT and trial medication
Summary of when trial‑related services and medications may be zero‑rated or standard‑rated for value added tax, with emphasis on seeking finance and procurement advice.

Distinguishing between pharmacy good clinical practice and good manufacturing practice responsibilities
Clarifies pharmacy roles in tracking, accountability and storage under good clinical practice versus manufacturing‑related responsibilities under good manufacturing practice.

Working with pharmacy services
Signposts guidance to help researchers work effectively with pharmacy departments in managing on‑site trial medication.