Drug database
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 | |
| 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 | ||
|
KLH-20 version 6 |
Application for Approval / Notification of a Clinical Trial | YES | 10.4.2020 | KLH-20 version 5 | |
| Documentation submitted with the application for approval of a clinical trial | YES | 21.01.2019 | KLH-19 | ||
| KLH-17 version 1 | Investigator | NO | 10.06.2011 | ||
|
KLH-16 Version 1 |
Sponsor | NO | 10.06.2011 | ||
|
KLH-12 version 3 |
Requirements for ducumentation of Good Manufacturing Practice upon Submitting Applications for Approval/Notification of a Clinical trials | NO | 01.01.2012 | KLH-12 version 2 | |
| 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 |