ePrivacy and GPDR Cookie Consent by TermsFeed Generator

Guidelines and Forms

Medicinal Products - Clinical Trials
  Name En. v. Valid. since Replaces Amends
KLH-22 version 5

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

YES 1.6.2022 KLH-22 version 4  

KLH-21 version7

Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation YES  20.7.2018 KLH-21 version 6  
version 6
Application for Approval / Notification of a Clinical Trial YES 10.4.2020 KLH-20 version 5  

version 3

Documentation submitted with the application for approval of a clinical trial YES 01.04.2024 KLH-19 version 2  
KLH-17 version 1 Investigator NO 10.06.2011    


Version 1

Sponsor NO 10.06.2011    
version 4
Requirements for ducumentation of Good Manufacturing Practice upon Submitting Applications for Approval/Notification of a Clinical trials YES 01.04.2024 KLH-12 version 3  
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 10.08.2018 SKP-1 version 0