Germany CTIS Secondary-Use Consent Requirements

What counts as secondary or future use

Use this pathway when data or samples collected around the clinical trial will be used for research outside the approved clinical-trial protocol. Examples include:

• storage in a biobank for future projects
• research on other diseases, treatments, or scientific questions
• future genetic, genomic, biomarker, or exploratory analyses not defined in the protocol
• sharing with future academic or commercial research partners beyond the trial
• linkage with other datasets for new research purposes
• future contact for additional research or new consent

Do not call protocol-required safety, efficacy, regulatory, or legally required retention secondary use merely because it occurs after the participant's last visit.

Germany's separate-document rule

AKEK states that optional additional processing or sample use outside the clinical trial must meet clarity and comprehensibility requirements through its own information and consent document, separate from the main trial.

Mandatory when optional use outside the protocol is proposed. The participant must be able to join the main trial and decline the additional research.

AKEK identifies limited exceptions where processing or sample use remains tied to the investigational medicine, including later marketing-authorization procedures, later necessary safety or efficacy investigations, and other legal duties of the sponsor or investigator within required retention periods. Describe those activities in the main trial information rather than presenting them as optional future research.

Required Part II documents

Separate secondary-use information sheet

Mandatory. Explain the additional purpose, scope, sample and data types, storage, coding, governance, sharing, transfers, possible commercial involvement, return of results, re-contact, duration, and withdrawal.

Separate secondary-use consent form

Mandatory. Provide clear optional choices. A participant should be able to say yes or no without affecting main-study participation, treatment, reimbursement, or the relationship with the site.

Parent or representative version

Conditional. Prepare a version for the person or persons with legal authority when minors or adults without capacity are included. Address future re-consent when a minor reaches adulthood or an adult regains capacity.

Biological-sample compliance form

Conditional. Submit the EudraLex form under Part II section S when biological samples are collected, stored, used, or transferred. Ensure that it matches both the main protocol use and the optional secondary-use document.

Information that should be clear

Purpose and scope

State whether future research is limited to the same disease, medicine, or research area or is broader. Avoid claiming unlimited consent when governance or data-protection information sets real limits.

Data and sample types

List the data and biological materials covered, including associated clinical data, images, genetic data, residual samples, and samples collected only for the optional project.

Coding and identifiability

Explain whether material is coded, pseudonymized, or irreversibly anonymized. Do not promise anonymity when a code key remains or re-contact is possible.

Storage and governance

Identify the responsible organization, storage location or type of repository, intended duration, access controls, review process, and conditions for release to other researchers.

Genetic analysis and findings

Explain the type and broad purpose of genetic work, possible family relevance, whether individual findings may be returned, whether return is optional, and how clinically relevant findings are handled.

Sharing and transfers

Describe recipient categories, academic and commercial access, international transfers, safeguards, and any material or data-transfer controls. The consent wording must match the actual data and sample flow.

Commercial use and intellectual property

Explain whether commercial research or product development may occur and whether participants receive any share of resulting intellectual property or revenue. Avoid language that suggests a financial return when none is planned.

Consent logic

Use one clear optional decision for each genuinely independent activity. Common choices may include:

• future use of coded data
• future use of stored samples
• genetic analysis
• sharing with commercial partners
• transfer to countries outside the European Economic Area
• re-contact for new projects or findings

Do not create many choices that cannot be implemented operationally. The sample inventory, database, withdrawal process, and transfer controls must be able to honor each offered choice.

Withdrawal

Explain how consent can be withdrawn and who to contact. State what can happen to remaining samples, coded data not yet used, data already included in completed analyses, and information that must be retained under law.

Avoid a blanket promise that every copy can be retrieved after data or samples have been shared or results have been generated. Explain the limits specifically and in plain language.

Relationship with main-study participation

The main information sheet may introduce the optional project and direct the reader to the separate document. The main consent form should not make the optional yes box a condition of trial participation.

Keep protocol use and future use aligned across:

• the protocol and sample plan
• the main Patient Information Sheet and Informed Consent Form
• the separate secondary-use document
• the Part II biological-sample compliance form
• the GDPR statement and data-flow description
• laboratory, biobank, and transfer arrangements

German language and signatures

The participant or representative information and consent must be in German. Submit blank documents in CTIS Part II. When consent is obtained, the participant or authorized representative and the person conducting the approved information process sign and date the form in writing or through a compliant electronic process.

For planned non-German-speaking participants, use qualified translations and maintain communication in a language the participant and representative understand.

German template

AKEK publishes a 2022 model text for optional additional collection of biological samples and associated data during a clinical drug trial for use outside the protocol. AKEK's 2022 CTR handout points to this separate-document approach. Adapt the model to the actual project and do not present it as a mandatory unchanged form.

Use the Germany patient-facing document QC checklist before submission.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains the full English guide series.

Other language versions

Read this guide in German.