Standardised with modifiable components – An example is provided on the downloadable accessible PIL which will require modification to reflect your trial.
- The title trial should be short, in large font (minimum of font size 20) and written in plain language.
- Avoid using medical terminology in the title as this could put people off reading the accessible PIL.
- Include the words, ‘Information leaflet for a clinical trial’ under the title. This will make it clear to people that this is an information leaflet for a research trial, rather than a clinical information leaflet about the treatment.
- Include a trial logo which incorporates the trial acronym at the top right of the page. A trial logo is useful as it helps people recognise and remember the trial.
- Include the trial logo on all subsequent trial correspondence.
- It is important to include logos that people can recognise, to show that this is from a trusted organisation. For example, if the trial is being run in the NHS, also include the local NHS Trust logo at the top right of the page. This can reassure people that the trial can be trusted.
- You may wish to add a university logo, if relevant to your trial.
- Include a sentence to explain who people should contact if they need to speak to someone in their own language.
- It is important that this is at the top of the front page to let people whose first language is not English know how to contact the research team.
- Underneath this, include ‘hello’ in different languages to emphasise that this trial is for everyone.
- In the downloadable accessible PIL, we have included the languages with the greetings most commonly spoken by the communities involved in this project: Traditional Chinese, Romanes, Somali, Arabic, Romanian, Bulgarian, Hungarian, Bengali, Punjabi, Urdu and English. For your trial, consider the demographics of your target population and which languages to include here.
- Work with communities or translators to find the most appropriate word for ‘hello’ as this is not always straightforward, for example, the direct translation may not exist or may be context-specific in some languages.
- A sentence should be included to explain that all words in bold are medical words, and that these are explained.
- Medical and research terminology is not accessible to everyone, and use of these terms should be minimised throughout the accessible PIL. However, some terms are unavoidable e.g. the name of a condition or a treatment. Ensure that you explain the term in plain language before you use the term.
- Make sure that terminology is consistent throughout the accessible PIL. Avoid using ‘clinical trial’ and ‘study’ interchangeably.
- Include a sentence to explain that more information about clinical trials is provided at the end of the leaflet.