Germany has a primary registry, German Clinical Trials Register (DRKS) which has a provision to publish protocol registrations. DRKS is a World Health Organization (WHO) recognized primary registry. In addition, PharmNet.Bund has a requirement to post the results of clinical trials that are conducted in Germany or if the product is authorized in Germany. Posting protocol registration in DRKS is voluntary, whereas, it is mandatory to submit study results to PharmNet.Bund.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| EU CTR | EU CTR via Clinical Trial Applications | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4) |
English |
| EU PAS | EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) | Post-authorization Safety Efficacy Studies |
English |
| PharmNet.Bund | Mandatory National Database (includes Ethics Requirement) | Sponsor, Marketing authorization holder | Sponsor at end of study |
Interventional (Phase 2-4);Observational |
German
English |
| BfArM Non-Interventional Studies (NIS) | Mandatory National Database (includes Ethics Requirement) | Competent authority | Sponsor at end of study |
Observational |
German
English |
| Paul Ehrlich Institute (PEI) | Mandatory National Database (includes Ethics Requirement) | Competent authority | Clinical Trial Application |
Interventional (Phase 2-3) |
German
English |
| German Clinical Trials Registry (DRKS) | Academic/Patient Registries/Voluntary | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 0-4);Observational |
German
English |
| University Hospital Cologne | Academic/Patient Registries/Voluntary | Investigator | Through a dedicated registration platform (process independent from clinical trial application) | All ongoing studies under the hospital |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| EU CTR | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies) | |
| EU PAS | Registration |
Yes |
Before the start of data collection |
| Results |
Yes |
Within 12 months of end of data collection | |
| PharmNet.Bund | Registration |
No |
Not applicable (NA) |
| Results |
Yes |
Within 12 months of Study Completion (Authorized Products); Within 6 months of Product Authorization (Unauthorized Products) | |
| BfArM Non-Interventional Studies (NIS) | Registration |
No |
NA |
| Results |
Yes |
Within 12 months of end of study | |
| PEI | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Within 12 months of Study Completion (Authorized Products); Within 6 months of Product Authorization (Unauthorized Products) | |
| DRKS | Registration |
No |
Prior to enrollment |
| Results |
No |
NA | |
| University Hospital Cologne | Registration |
No |
NA |
| Results |
No |
NA | |
Other Mandatory Requirements
- A Clinical Trial Application (CTA) is required to be submitted to the national competent authorities (NCA) – Federal Institute for Drugs and Medical Devices (BfArM) or Paul-Ehrlich Institute (PEI) by the sponsor via EudraCT.
- Results are required to be posted on EudraCT per European Directive 2001/20/EC.
Registry Updates
- September 2021: EU CTIS Webinar - European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021: The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the … Continue reading "September 2021: EU CTIS Webinar"
- September 2021: CTIS Training Update - European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021. The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial … Continue reading "September 2021: CTIS Training Update"
- September 2021: CTIS Training Updates - European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and … Continue reading "September 2021: CTIS Training Updates"
References
- Clinical trial results reports. https://www.pharmnet-bund.de/static/de/unternehmen/ergebnisberichte/index.html.