Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of Timelines.
Introduction: To safeguard the safety and interests of subjects participating in clinical trials, their conduct is heavily regulated. The EU Clinical Trials Regulation (CTR) 536/2014 brings fundamental changes that will require sponsors to adapt their current way of working. One major change is the...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 57; no. 5; pp. 1113 - 1121 |
|---|---|
| Main Authors: | , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Springer Nature
Sep2023
|
| Online Access: | View this record in EBSCOhost |