Drug database
Clinical Trials
| Guideline | Name | Eng.version | Valid since | Replaces | Amends |
|---|---|---|---|---|---|
| KLH-22 version 5 | Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet/Informed Consent Form | YES | 01.06.2022 | KLH-22 version 4 | |
| KLH-19 version 3 | Requirements on authorisation of clinical trials on medicinal products – data required for the pharmaceutical part of the documentation | YES | 11.09.2024 | KLH-19 version 2 | |
| KLH-12 version 4 | Requirements for Documentation Relating to Compliance with Good Manufacturing Practice in the Submission of Applications for Clinical Trial Authorisation | YES | 11.09.2024 | KLH-12 version 3 | |
| SKP-1 version 3 | Certificate of Good Clinical Practice Issuing | NO | 02.04.2026 | SKP-1 version 2 | |
| SKP-2 version 1 | Good Clinical Practice Inspection Procedure | NO | 24.07.2026 | – | |
| KLH-CTIS-01 version 3 | The Guideline SÚKL´s Ethics Committee and Multicentric Ethics Committees | YES | 28.01.2026 | KLH-CTIS-01 version 2 |