Guidelines and Forms

Medicinal Products - Clinical Trials
  Name En. v. Valid. since Replaces Amends
KLH-22 version 3

Requirements Governing the Text of Patient Information Leaflet/Informed Consent Form

YES 14.9.2017 KLH-22 version 2  
KLH-21 version 6 Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation YES  01.12.2016 KLH-21 version 5   
version 5
Application for Approval / Notification of a Clinical Trial YES 01.01.2013 KLH-20 version 4  

version 1

Documentation submitted with the application for approval of a clinical trial YES 21.10.2008 KLH-19  
KLH-17 version 1 Investigator NO 10.06.2011    


Version 1

Sponsor NO 10.06.2011    
version 3
Requirements for ducumentation of Good Manufacturing Practice upon Submitting Applications for Approval/Notification of a Clinical trials NO 01.01.2012 KLH-12 version 2  
KLH-11 version1 Ethics Committees YES 10.06.2011 KLH-11  
KLH-10 version 1  Terminology and principles of good clinical practice YES 09.06.2011 KLH-10  
KLH-9 Investigator's brochure YES 01.06.1998    
KLH-8 Clinical trial protocol and protocol amendment(s) YES 01.06.1998    
SKP-1 Certificate of good clinical practice issuing NO 01.07.2009