Germany

DCT Feasibility Assessment Germany The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Germany in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European M...

2.1 Name of Regulatory Authority Paul-Ehrlich-Institut (“PEI”) and the Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (“BfArM”)   are the respective competent federal higher authoritie...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   In Germany, Ethics committees perform statutory tasks in accordance with the German Med...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The following electronic documents are required to be submitted via CTIS (the EU’s Clinical...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   No . Local Regulations do not require a PI/CI to be approved by a Health Authority, though they must meet certain criteria as outli...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The Federal Government’s export control policy is administered by the Federal Office for Economic Affairs and Export Control . Dual-use items, w...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/ guidance on the use of DCT ele...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Primarily, the GDPR needs to be adhered to.   Article 93 of the EU CTR 536/2014 reads as under: “ 1. ...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? There is no direct prohibition on the use of digital advertisements for the d...

10.1 Clinical Trial with Investigational Medicinal Product A trial application must be made via CTIS. The BfArM states that:  “CTIS will be the single entry point for submitting clinical trial information in the EU and the European E...

European Union 1. EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   2. EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.euro...

 None.