Medicinal Products - Clinical Trials
| Name | En. v. | Valid. since | Replaces | Amends | |
| KLH-21 version 4 | Reporting of adverse reactions for human medicinal products in clinical trials | YES | 1.11.2008 | KLH-21 version 3 | - |
|
KLH-20 version 4 |
Application for Approval / Notification of a Clinical Trial | YES | 1.11.2008 | KLH-20 version 3 | - |
| Documentation submitted with the application for approval of a clinical trial | YES | 21.10.2008 | KLH-19 | - | |
| KLH-17 | Investigator | NO | 1.1.2000 | - | - |
| KLH-16 | Sponsor | NO | 1.9.1999 | - | - |
|
KLH-12 version 3 |
Requirements for ducumentation of Good Manufacturing Practice upon Submitting Applications for Approval/Notification of a Clinical trials | NO | 1.1.2012 | KLH-12 version 2 | - |
| KLH-11 version1 | Ethics Committees | YES | 10.6.2011 | KLH-11 | - |
| KLH-10 version 1 | Terminology and principles of good clinical practice | YES | 9.6.2011 | KLH-10 | - |
| KLH-9 | Investigator's brochure | YES | 1.6.1998 | - | - |
| KLH-8 | Clinical trial protocol and protocol amendment(s) | YES | 1.6.1998 | - | - |
| SKP-1 | Certificate of good clinical practice issuing | NO | 1.7.2009 | - | - |
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