GLSP Resources

All GLSP related documents, guidelines, reports and templates.

Key Documents

Good Lay Summary Practice guideline
Publication in EudraLex Vol. 10: 4 October 2021
This guidance was developed in cooperation with the Roadmap Initiative to Good Lay Summary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities (NCA)).
9 July 2021 European Commission
Summaries of CT Results for Laypersons
Supersedes: Version 1 of 26 January 2017
Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, Version 2.
22 February 2018 European Commission
Clinical Trial Regulation
Coming into Force: 31 January 2022
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.
16 April 2014 European Commission
# Type Document Publisher Date Language Link
4 Lay titles for clinical trials Is industry achieving the balance EMWA - Medical Writing 2023 2023-03-01 English
3 PDF [Interview] AMWA Journal - Making of the GLSP AMWA Journal 2022-06-13 English
2 PDF [Workshop - Report] Implementing Good Lay Summary Practice The GLSP 2022-04-21 English
1 PDF The Official GLSP Guidance European Commission 2021-10-04 English