Germany

Germany

German Clinical Trials Register (DRKS)

Verified on August 4, 2022

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

  • August 2022: CTIS Update - The below update was posted on the What’s New Section of European Medicines Agency’s event page Clinical Trials Information System (CTIS): Walk-in clinic on August 03, 2022: The date for the walk-in clinic is rescheduled from August 22, 2022 to August 31, 2022 due to technical issues. Walk-in clinics provide a platform for sponsors to … Continue reading "August 2022: CTIS Update"
  • August 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application over the What’s New Section on August 02, 2022, with the below update: The video recording of the CTIS bitesize talk held on June 23, 2022, is now available on the event … Continue reading "August 2022: CTIS Update"
  • July 2022: What’s New on EudraCT - European Medicines Agency (EMA) updated the EudraCT homepage by providing the following update over the What’s New section on July 29, 2022: There are a considerable amount of clinical trials that are currently marked as ‘ongoing’ in the EudraCT database. In view of the upcoming transition to CTIS, sponsors are encouraged to verify the overall … Continue reading "July 2022: What’s New on EudraCT"

References