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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 3

Documentation submitted with the application for approval of a clinical trial YES 01.04.2024 KLH-19 version 2  
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  
SKP-1 Certificate of good clinical practice issuing NO 10.08.2018 SKP-1 version 0