Clinical Trials – Regulation EU No. 536/2014
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, and repealing Directive 2001/20/EC.
Good Lay Summary Practice
The “Good Lay Summary Practice” or “GLSP” provides recommendations for the patient-centric preparation and dissemination of summaries of results from clinical trials in lay language as required by the EU Clinical Trials Regulation 536/2014 and by global transparency commitments of pharmaceutical and academic sponsors.