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) |
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EU CTR | EU CTR via Clinical Trial Applications | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4) |
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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 |
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PharmNet.Bund | Mandatory National Database (includes Ethics Requirement) | Sponsor, Marketing authorization holder | Sponsor at end of study |
Interventional (Phase 2-4);Observational |
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BfArM Non-Interventional Studies (NIS) | Mandatory National Database (includes Ethics Requirement) | Competent authority | Sponsor at end of study |
Observational |
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Paul Ehrlich Institute (PEI) | Mandatory National Database (includes Ethics Requirement) | Competent authority | Clinical Trial Application |
Interventional (Phase 2-3) |
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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 |
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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 |
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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
- June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment - European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022: KPIs to monitor the European clinical trials environment: It is the second report … Continue reading "June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment"
- June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated about the upcoming events of Organisation Management System (OMS) Trouble Shooting Session for CTIS users to the What’s New Section on June 27, 2022: EMA will be hosting several OMS trouble shooting sessions on the following dates: July 21, 2022: 14.00 to 15.00 (CEST) September 22, 2022: 14.00 to 15.00 (CEST) … Continue reading "June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- June 2022: CTIS Update - European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS) bitesize talks over the What’s New Section on June 27, 2022: EMA will host two bitesize talks, CTIS bitesize talks: Notifications – Part 1 and Notifications – Part 2 on September 28, 2022, and October 20, 2022, respectively. The sponsors will get an … Continue reading "June 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.