1. Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.
The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators. The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device