Woman reads patient information leaflet
All patients need easy-language medicine instructions. And information the size of a newspaper does not help!

Plain language pharmaceutical info

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. This saves you time, and helps you get on with other work.

As you know, patients need clear information for their wellbeing and safety.  Dangerous misunderstandings can happen because:

Please get in touch if you’d like help with the following, e.g:

Surgeons inserting an implantable medical device in the operting theatre
When its inside your insides. Patients need clear and concise medical device instructions, to stay safe.

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:

Lay (plain language) summaries

Lay language communications: Pharmacist explains medicines information in lay language to a femaile customer.

Informed consent/assent

Please Read Carefully: Research nurse discusses informed consent documents with patients.

Medical device SSCP summaries

Cochlear implant devices

References and useful information

1
2021
National Literacy Trust
Adult literacy: Information on adult literacy in the UK and the Books Unlocked programme
2
2021
NIH National Library of Medicine
Introduction to health literacy
3
2018
Biros, M
Capacity, Vulnerability, and Informed Consent for Research
4
2021
European Society of Medical Oncology (ESMO)
Public policy: EU Clinical Trials Regulation. (A quick overview)
5
2014
European Parliament and the Council
Clinical Trial Regulation (EU) No 536/2014
6
2022
Future Medicine
Plain language summaries of publication articles
7
2021
European Commission
Guidance: Good Lay Summary Practice (Eudralex Vol 10, Chapter V additional documents)
8
2009
European Commission
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
9
2021
Regulatory Affairs Professionals Society
New guide to clinical trial lay summaries available for EU sponsors
10
2016
European Medicines Agency
ICH E6 (R2) Good clinical practice
11

2021

European Commission Directorate-General for Research & Innovation.
Horizon Europe Research and innovation funding programme until 2027. How to get funding, programme structure, missions, European partnerships, news and events.
12
2019
European Commission
MDCG- 2019-9 Summary of Safety and Clinical Performance. A guide for manufacturers and Notified Bodies
13
2021
BMC - Springer Nature
ISRCTN Registry for UK clinical trial registration and reporting of results
14
2021
UK Health Research Authority
Make it Public: transparency and openness in health and social care research
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