The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.
“Good Lay Summary Practice” (“GLSP”) provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language. This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“EU CTR”) and a transparency obligation to all trial participants and the interested public.
GLSP Quick Guide contains core extracts from the GLSP Handbook and may serve as an overview of the recommendations offered in the Handbook. Since the intention of the GLSP is to provide practical recommendations and strive for good lay summary practices, professionals directly involved in lay summary projects are encouraged to read the full handbook to benefit from the detailed recommendations.
GLSP recommends clinical trial sponsors to organise the lay summary process (“LS process”) in four steps: planning, development, translation, and dissemination.
A stepwise approach will help sponsors with their proactive planning and execution and will ensure a high quality of the lay summary (“LS”).
It is recommended that the trial sponsor determines which output or deliverables may be desired before a next step is initiated. For easy navigation, both the Quick Guide and the Handbook are organized in the same way.
Check Out the updated guidance by clicking this LINK