Plain language medicines information
Please Read CarefullyTM is owned and managed by specialist health writer Jane Lamprill. She can turn your scientific text into ‘easy-read’ information for your patients and the public.
As you know, patients need clear information for their wellbeing and safety. Dangerous misunderstandings can happen because:
- Readers’ literacy and health literacy skills vary widely.(1,2)
- Writers and readers might speak different first languages.
- People who are very unwell, don’t have the mental energy to understand complex information.(3)
FDA requires easy-read medicines info
In July 2022, the US medicines regulator FDA published Patient Labeling for Human Prescription Drug and Biological Products — Content and Format. “The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products”.
Please get in touch if you’d like help with the following, e.g:
- Informed consent/assent information for adults and children
- Clear, concise patient medication instructions
- Lay language summaries of clinical trial results
- Plain language summaries of study resutls for journal articles
- Plain language copywriting for patient information websites
- Medical writing for child research participants aged 3yrs+
- SSCP medical device lay summaries (below)
Medical device SSCP lay summaries
As you know, the EU Medical Device Regulation requires a lay Summary of Safety and Clinical Performance for all Class III devices, including Active Implantable Medical Devices.
BUT writing SSCP information for the public is time consuming if your expertise is scientific writing and you have a CE application deadline.
Specialist health writer Jane Lamprill can work with you, and help write the lay language documents you need e.g:
- SSCP lay summaries for patients and the public
- Patient-friendly medical device user instructions
- Website copy for patients/carers
- Medical device information for children
Lay (plain language) summaries
- EU Clinical Trial Results (4-9)
- UK ISRCTN Registry (13,14)
- Non-technical language for:
- Adult studies
- Paediatric (pediatric) studies
- Children aged 6-17yr
Informed consent/assent
- Informed consent materials:
- All phases of clinical trials (10)
- Horizon Europe participants (11)
- Adults, parents & children
- Info for people with disabilites
- Artwork for little child assent info
Medical device SSCP summaries
- EU Medical Device Summaries (12)
- for Safety & Clinical Performance
- Plain language info for patients
- SSCP readability assessments
- SSCP user-testing & rewrites
- SSCP reports for Notified Bodies
References and useful information
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1 |
2021 |
National Literacy Trust |
Adult literacy: Information on adult literacy in the UK and the Books Unlocked programme |
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2 |
2021 |
NIH National Library of Medicine |
Introduction to health literacy |
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3 |
2018 |
Biros, M |
Capacity, Vulnerability, and Informed Consent for Research |
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4 |
2021 |
European Society of Medical Oncology (ESMO) |
Public policy: EU Clinical Trials Regulation. (A quick overview) |
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5 |
2014 |
European Parliament and the Council
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Clinical Trial Regulation (EU) No 536/2014
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6 |
2022 |
Future Medicine |
Plain language summaries of publication articles |
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7 |
2021 |
European Commission
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Guidance: Good Lay Summary Practice (Eudralex Vol 10, Chapter V additional documents) |
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8 |
2009 |
European Commission
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Eudralex Volume 10 Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA) in accordance with Article 41 of Regulation (EC) No 1901/2006 |
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9 |
2021 |
Regulatory Affairs Professionals Society
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New guide to clinical trial lay summaries available for EU sponsors |
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10 |
2016 |
European Medicines Agency
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ICH E6 (R2) Good clinical practice
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11 |
2021 |
European Commission Directorate-General for Research & Innovation.
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Horizon Europe
Research and innovation funding programme until 2027. How to get funding, programme structure, missions, European partnerships, news and events.
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12 |
2019 |
European Commission |
MDCG- 2019-9 Summary of Safety and Clinical Performance. A guide for manufacturers and Notified Bodies |
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13 |
2021 |
BMC - Springer Nature |
ISRCTN Registry for UK clinical trial registration and reporting of results |
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14 |
2021 |
UK Health Research Authority |
Make it Public: transparency and openness in health and social care research |