Germany CTIS Patient Information and Consent Requirements

Purpose and CTIS location

The Patient Information Sheet gives the person the information needed to decide freely whether to participate. The Informed Consent Form records that decision and the required permissions.

Submit the forms under Part II section L, Subject information, informed consent form and informed consent procedure. Use a descriptive name such as L1_SIS and ICF_adult patients_DE. The recruitment and consent process itself is described separately under K1.

German language requirements

Mandatory. Documents intended for the participant or legal representative must be submitted in German. Administrative parts of the application may be German or English.

If the protocol plans to enroll people who do not understand German, prepare participant documents in a language each person understands. AKEK expects a statement that a qualified translator will produce the translations and that communication with the participant and any representative will remain possible throughout the trial.

Do not use an interpreter as a substitute for translated documents when the enrollment of that language group is planned. The consent procedure should explain how translations, interpreters, and version control will be handled.

Readability and document design

The information must be comprehensive but concise, clear, relevant, and understandable to a layperson. Explain medical and regulatory terms when first used. Keep the most decision-relevant facts early in the document.

AKEK's eTIC approach recommends a short study-specific overview at the front, a clear contents structure, and space to record additions made during the consent conversation. These design choices are recommended, not separate legal requirements.

Use readable type, informative headings, short paragraphs, and consistent terms. Avoid copying protocol language that does not help a participant decide.

2026 AKEK review guideline

AKEK’s guideline for ethics-committee review of participant information and consent documents was published on 8 April 2026 and took effect on 9 April 2026. It applies to medicinal-product clinical trials under Regulation (EU) No 536/2014 and the other study categories covered by the guideline.

Use the AKEK structure and text modules as the baseline, then add all study-specific information. Ethics committees review those additions for completeness, accuracy and lay readability. If a project requires a deviation from the model text, explain the reason and make the deviation visibly identifiable; material, unjustified deviations may be objected to.

For six months after the guideline took effect, ethics committees take account of applicants’ transition processes where the model texts cannot yet be implemented immediately. New submissions should therefore be aligned with the guideline now.

Core content of the German Patient Information Sheet

Study identity and purpose

Explain the study title, EU trial number, sponsor, responsible site, why the study is being done, the investigational treatment, the trial phase where relevant, and the planned number of participants. State what is experimental and what is standard care.

Voluntary participation and alternatives

State that participation is voluntary and that refusal or later withdrawal will not cause disadvantage. Explain the available treatment alternatives and what care is available outside the trial. Do not imply that the investigational treatment is better or guaranteed to help.

Assignment and blinding

Explain randomization, treatment groups, placebo, blinding, and the chance of receiving each option in plain language. Explain when treatment assignment may be revealed for safety or medical care.

Procedures and participant burden

Describe visits, treatment, tests, sample collection, questionnaires, diaries, devices, hospital stays, restrictions, and follow-up. Separate research-only procedures from normal care. State the expected duration of participation and the total trial duration where useful.

Risks, discomforts, and benefits

Present important known and reasonably foreseeable risks in a useful order. Include uncertainty, treatment-specific risks, procedure risks, interactions, reproductive risks, and practical burdens. Explain expected benefit without overstating it and state clearly when direct benefit is not expected.

Pregnancy, contraception, and reproductive measures

Where relevant, explain pregnancy testing, contraception, breastfeeding restrictions, sperm or egg donation restrictions, reporting of pregnancy, treatment discontinuation, and proposed follow-up. The requirements must match the protocol and current safety guidance.

If the trial plans separate maternal, partner, pregnancy-outcome, or infant follow-up, use the Germany pregnancy follow-up consent guide

Biological samples

Explain which samples are collected, why, how much, where they are analyzed or stored, coding, transfers, retention, destruction, and whether genetic analysis is planned. Distinguish protocol-required use from optional future research.

Optional use outside the protocol should not be hidden inside the mandatory study consent. The Germany secondary-use consent guide explains the separate-document rule.

Personal data and medical-record access

Identify the data controller and relevant contacts. Explain what personal and health data are collected, the purposes, coding or pseudonymization, who can access identifiable records, sponsor and authority review, recipients, transfers, storage, rights, withdrawal, and legally required continued processing.

Germany requires the participant or legal representative to consent expressly, in writing or electronically, to processing personal data, especially health data. The information must cover inspection access, pseudonymized transfer to the sponsor and authorities, safety reporting, regulatory submissions, continued processing after withdrawal where legally necessary, and the required retention period.

Costs, reimbursement, and payment

Explain what the participant receives, what expenses are reimbursed, payment timing, prorating, and whether any costs may fall to the participant or health insurer. Payment must not create undue influence.

Compensation and insurance

Explain Germany's trial-participant insurance in plain language. Give the insurer's name and address, contact details, policy or reference number, the broad scope of cover, and the participant's practical obligations after a possible injury. Ensure that the wording matches the submitted certificate and policy terms.

Withdrawal, stopping treatment, and new information

Explain how the participant can withdraw, what happens to study treatment and follow-up, which data may still be processed, and whether samples can be destroyed or will be retained for a lawful reason. Explain how new information that could affect willingness to continue will be communicated and when re-consent is required. When a material change requires already enrolled participants to be informed and consented again, AKEK recommends a short, version-dated document focused on the change and explaining why a new document is being provided. For participants enrolled after the change, submit updated full documents with the revisions clearly marked for ethics review.

Contacts and results

Give contacts for study questions, medical emergencies, participant rights, data protection, insurance, and the German federal contact point where applicable. Explain that a lay summary of results will be made available through the EU system and include the EU trial number.

Consent form structure

The signature form should record only clear, reviewable choices. It should confirm that the participant:

• received and understood the current information version
• had enough time and an opportunity to ask questions
• understands voluntariness and withdrawal
• agrees to trial participation
• expressly agrees to the required processing of personal and health data
• agrees only to optional activities that are separately described and separately selectable
• receives a signed and dated copy

Do not combine refusal of an optional sample, genetic, future-use, or re-contact activity with refusal of the main trial unless the protocol makes the activity scientifically necessary and the application justifies that position.

Consent interview and signatures

For a capable adult, the consent interview must be conducted by an investigator who is a physician or dentist, or by a physician or dentist who is a member of the trial team. The participant must have the chance to ask questions before deciding.

The participant and the person conducting the interview sign and date the consent after the information process and before any trial-specific procedure. Germany permits written or compliant electronic consent. An electronic process must still satisfy the Clinical Trials Regulation, German law, identity, dating, record, copy, and accessibility requirements.

If a capable person cannot write, do not redirect the person into the legal-representative pathway. Use the Germany impartial witness consent guide

Population-specific variations

The capable adult patient document is the default, not a universal form. Use separate, adapted documents for:

• healthy volunteers
• minors and their legal representatives
• adults without consent capacity and their legal representatives
• emergency enrollment and later consent
• pregnancy follow-up
• optional secondary use of data and samples

For minors, the 2026 guideline specifically calls for separate age-adapted documents for children aged 7–11, adolescents aged 12–17 and their legal representatives. Re-consent is required if the minor gains consent capacity during the study, and no later than adulthood.

German templates and tools

AKEK’s model texts form the drafting baseline under the 2026 review guideline and must always be supplemented with study-specific information. For capable adult patients, AKEK currently recommends continuing to use model text version 1.2 dated 25 November 2022 while the revised adult model is being finalized. Use the current published AKEK model in force at the time of submission.

AKEK also provides eTIC as an authoring aid for consent documents. It does not replace protocol-specific drafting, legal review, translation control, or the CTIS application.

Return to the Germany CTIS hub

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

Other language versions

Read this guide in German.