Mother reads medicines information on an aircraft.
Your medicines info can be read by anyone, anywhere. Think in-flight brochure: short words, short sentences and short paragraphs.

Pharmaceuticals & medical devices

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.

We have a mission-critical safety obligation to provide medical information in easy language. Dangerous misunderstandings can happen because:

 

Please see below if you’d like help with:

Lay language communications: grandfather and small boy wait in a clinic room
Jane Lamprill can work with your team to write lay (plain) language summaries for adults and older children.

Do you need help with lay summaries?


The EU/536/2014 Clinical Trial Regulation (5)
will come ‘into application’ on 31 January 2022. Pharmaceutical companies must upload lay summaries of all clinical study results, onto the public section of the European Medicines Agency’s (EMA) database.

This applies to any clinical trial used as part of a Marketing Authorisation Application in Europe. Lay summaries must be posted from the date of last patient last visit after:

ISRCTN Registry: this ‘International Standard Randomised Clinical Trial Number’ will apply from early January 2022. All UK ethically approved medicines’ research will be registered automatically at a ‘one-stop-shop’. This includes for the Health Research Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) and the World Health Organisation. Lay summaries are required for the proposed research, and for the results.

Feel free to get in touch if you need help with lay summaries for:

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
2015
European Commission
Jane Lamprill: Please Read Carefully: Response to EU consultation, Summary of Clinical Trial Results for Lay Persons
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
2017
European Commission
Summaries of Clinical Trial Results for Laypersons
10
2016
European Medicines Agency
ICH E6 (R2) Good clinical practice
11

2021

European Commission Directorate-General for Research & Innovation.
Horizon Europe Programme: Advice for funding applicants
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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