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 outside Germany and the European Economic Area (EEA) i.e., exclusively in third countries. Posting protocol registration in DRKS is voluntary, whereas, it is mandatory to submit study results to PharmNet.Bund, for studies conducted outside of Germany. From January 31, 2022, European Union Clinical Trial Information System (EU CTIS) has become functional, and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| EU CTIS | Not Applicable | Competent authority, Sponsor | Clinical Trial Application |
Interventional (Phase 1-4) |
English |
| 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 CTIS | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies) | |
| 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.
- Results will now be required to be posted on EU CTIS per Regulation (EU) No 536/2014.
Registry Updates
- November 2022: What’s New on EudraCT - European Medicines Agency updated the EudraCT homepage by providing the following update over the What’s New section on November 14, 2022: There are issues reported by the users with uploading clinical trial application (CTA) XML files on EudraCT. This issue is caused by a SPOR malfunction impacting EudraCT and CTIS. As of November 21, 2022, … Continue reading "November 2022: What’s New on EudraCT"
- October 2022: CTIS Training Update - European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 28, 2022, by adding new versions for the below documents in Module 13 – Clinical study reports submissions: Quick guide: Clinical Study Reports submission (v1.1): Updated by providing information on the process to request the Marketing Authorisation Holder (MAH) … Continue reading "October 2022: CTIS Training Update"
- October 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 1 over the What’s New Section on October 26, 2022: The video recording of the CTIS bitesize talk held on September 28, 2022, is now available on the event page. This bitesize talk provided an opportunity for sponsors … Continue reading "October 2022: CTIS Update"
References
- Clinical trial results reports. https://www.pharmnet-bund.de/static/de/unternehmen/ergebnisberichte/index.html.
- Clinical Trials Regulation. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation#transition-period-for-clinical-trial-sponsors-section.
- Clinical Trials Information System: training and support. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.