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
- December 2021: In Vitro Diagnostic Medical Devices Regulation Update - European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021: The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage … Continue reading "December 2021: In Vitro Diagnostic Medical Devices Regulation Update"
- December 2021: CTIS Training Update - European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents: Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will … Continue reading "December 2021: CTIS Training Update"
- December 2021: CTIS Training Program - European Medicines Agency updated about the upcoming event Clinical Trials Information System sponsor user training program over the What’s New Section on December 16, 2021: The event page notifies about EMA’s plan to conduct six different virtual training courses as part of the training program for sponsor users and the dates on which these courses will be … Continue reading "December 2021: CTIS Training Program"
References
- Description of entry fields. German Clinical Trials. https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields. Published September 18, 2018. Accessed September 18, 2018.