Germany CTIS Submission Guide Hub

Germany CTIS guides in English

Germany CTIS Part II document checklist

Use this guide to identify the German Part II documents, their CTIS locations, language, template, signature, and submission-time requirements.

Read the Germany CTIS Part II document checklist guide

Germany patient information and consent requirements

Use the main consent guide to prepare the German Patient Information Sheet and Informed Consent Form for a capable adult patient.

Read the Germany patient information and consent requirements guide

Germany patient-facing document QC checklist

Use this checklist to compare every participant document with the protocol, German law, consent logic, data terms, and the intended study population.

Read the Germany patient-facing document QC checklist guide

Germany healthy volunteer consent requirements

Use this variation when the trial enrolls healthy volunteers rather than patients receiving treatment for a condition.

Read the Germany healthy volunteer consent requirements guide

Germany minor consent and assent requirements

Use this guide when children or adolescents will participate and separate information, parental permission, assent, or the minor's own written consent may be needed.

Read the Germany minor consent and assent requirements guide

Germany limited-capacity participant and legal representative consent requirements

Use this guide for adults who cannot provide valid consent and for the documents required from their legally designated representatives.

Read the Germany limited-capacity participant and legal representative consent requirements guide

Germany emergency enrollment consent requirements

Use this guide only when the protocol relies on the narrow emergency exception in Article 35 of the Clinical Trials Regulation.

Read the Germany emergency enrollment consent requirements guide

Germany impartial witness consent requirements

Use this guide when a capable participant understands the trial but cannot write or sign in the usual way.

Read the Germany impartial witness consent requirements guide

Germany pregnancy follow-up consent requirements

Use this guide for follow-up of a pregnant trial participant or the pregnant partner of a trial participant, including maternal and child data.

Read the Germany pregnancy follow-up consent requirements guide

Germany secondary-use consent requirements

Use this guide when data or biological samples will be collected for optional research outside the clinical-trial protocol.

Read the Germany secondary-use consent requirements guide

Main German differences to plan for

Participant documents must be in German

The German Medicinal Products Act allows the application dossier in German or English but requires documents intended for the participant or legal representative in German. If planned recruitment includes people who do not understand German, the application should include a commitment to qualified translation and to communication in a language each participant and representative understands. The Germany patient information and consent guide explains the document and signature process.

German ethics review drives Part II

The registered ethics committee assesses the Article 7 Part II elements, including consent, recruitment, site and investigator suitability, insurance, data protection, and samples. BfArM or PEI validates the application and issues the national decision. Its decision is bound by the ethics committee's Part II assessment.

National forms and evidence matter

Germany recommends the current EU recruitment and consent-procedure template, EU investigator CV and declaration-of-interest templates, the AKEK site-suitability template, and AKEK adult information and consent model texts. Investigator regulatory-training certificates, an insurance certificate and terms, and a draft sponsor-site contract are part of the German document set where applicable. The Germany Part II document checklist maps these items to CTIS.

Vulnerable-population consent is not a wording change

Minors, adults without capacity, emergency enrollment, and participants unable to write follow different legal pathways. A separate document set and consent flow may be necessary. Start with the main consent guide, then use the relevant population guide before finalizing Part II.

Radiation applications changed in 2025

Since 1 July 2025, documentation for radiation procedures that require authorization or notification is routed through the competent federal authority with the clinical-trial submission. Required authorization documents are uploaded in Part II under suitability of facilities. Check the current BfArM or PEI radiation route before submission.

Other language versions

This package contains the English Germany hub and English guides. A German-language hub should be linked here only after the localized pages are published and their URLs have been verified.