Germany

Germany

German Clinical Trials Register (DRKS)

Verified on September 7, 2021

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


  1. 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.