Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) published a brand new Good Clinical Practice Guide on clinical trials conducted in the UK. I received my copy by post a few days ago and thought I’d review it here.
The Guide is based on Clinical Trials Directive 2001/20/EC, which governs the conduct of clinical trials across the EU, so it will be a useful additional resource for medical translators who work into or out of English. Unfortunately, it’s only available as a printed book. This is disappointing because PDF format or online access would have made it much more practical for searching.
The 500-plus page GCP Guide has 14 chapters that cover a wide range of topics such as Sponsors, Research Ethics Committees, Pharmacovigilance, Statistics, Monitoring and Quality Systems. There is a useful list of Abbreviations and a Glossary of common terms. For more details on the contents, check out the MHRA Q&As on the Guide.
Legislation, guidance and good practice
In the last few days I’ve browsed through the book to look up terminology I use when translating clinical trial documentation. I like the way a clear distinction has been drawn between the use of must and should in the book. Must means “by legislative requirement” (and is followed by a chapter endnote reference). Should indicates guidance. Recommended and suggested refer to good practice.
I’ve found a clear explanation of the differences between chief, coordinating, lead and principal investigators. Chief investigator is equivalent to the ICH definition of coordinating investigator (person in charge of the entire trial). Lead investigator is synonymous with the EU term principal investigator or PI (person who heads the team at a trial site). Interestingly, in the UK, the terms chief and principal are interchangeable in the case of a single-site trial, when the chief investigator is also the investigator at that site.
Another hot potato in medical terminology is the usage of active pharmaceutical ingredient (API), drug substance and active substance. They are all synonyms, but they’re not interchangeable. Thus, API is used in clinical trial documents (as confirmed in this Guide), drug substance is used in manufacturing processes and active substance in product information (i.e., Summary of Product Characteristics, Package Leaflet and Labelling). And what about active ingredient itself? Well, it has its place outside the above contexts, usually in patient-friendly information.
The Guide gives real-life examples of bad practice. Apart from helping to contrast good practice, these examples make a potentially dry book a bit more entertaining:
- In one obstetrics clinical trial, an inspector examined the insurance cover and found that pregnant women were excluded!
- In one double-blind trial, the subject’s active treatment was printed on a paper slip and placed in an envelope, but the latter was see-through when held up to the light!
Where can you get MHRA guides?
The MHRA publishes several GxP guides, including: