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 | |
| 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 | ||
| Documentation submitted with the application for approval of a clinical trial | YES | 01.04.2024 | KLH-19 version 2 | ||
|
KLH-12 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 |
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