Germany CTIS Part II Document Checklist

Recruitment arrangements

Mandatory. Submit a description of how potential participants will be identified, approached and informed, including the first act of recruitment. Use CTIS Part II section K, Recruitment arrangements. The description may refer to the protocol where the full process is already provided, but the submission still needs a clear first-recruitment-act statement.

Recommended. Use the EU informed-consent and recruitment procedure template, version 2.0. It is strongly recommended during the transition period and becomes the implemented template for new Part II submissions on 1 September 2026. The completed procedure document is dated but does not need a separate wet-ink signature under the Clinical Trials Regulation.

Conditional. Submit every recruitment advertisement, invitation, script, recording or response workflow that will be used. Participant-facing recruitment material must be in German. The Association of Medical Ethics Committees in Germany, known as AKEK, recommends neutral wording, a clear statement of the trial purpose and design, restrained presentation of payment and transparent contact details. The material is submitted unsigned in CTIS section K.

Participant information and informed consent

Mandatory. Submit the blank German Patient Information Sheet and Informed Consent Form for each participant group under CTIS Part II section L, Subject information, informed consent form and informed consent procedure. At submission they must show the EU trial number, study title, version and date, but no participant or physician signs them yet.

At consent, the participant and the physician or dentist who conducts the interview sign and date the form. The participant receives a copy. Germany also permits electronic informed consent when the applicable legal and electronic-signature requirements are met.

Use the AKEK structure and model wording applicable to the participant group. For the main adult-patient version, use the Germany Patient Information and Consent guide.

Population-specific documents

Conditional. Submit separate German documents for each population included in the protocol:

• Healthy volunteers. Use the adult healthy-volunteer variant. Follow the Germany healthy volunteer consent guide.
• Children aged 7 to 11, adolescents aged 12 to 17, and legal representatives. Follow the Germany minor consent and assent guide.
• Adults who lack capacity, their legal representatives and participants who may regain capacity. Follow the Germany limited-capacity consent guide.
• Emergency enrollment. Submit the emergency decision and later-consent procedure plus the information and consent forms used after enrollment. Follow the Germany emergency enrollment guide.
• Impartial witness consent. Submit the reason, witness selection and procedure where a participant cannot write. Follow the Germany impartial witness guide.
• Pregnancy follow-up. Submit separate consent where maternal, pregnancy-outcome or infant data will be collected beyond the participant’s existing consent. Follow the Germany pregnancy follow-up guide.
• Future use of data or samples outside the protocol. Use a separate optional document. Follow the Germany secondary-use consent guide.

Conditional. If non-German-speaking people may be enrolled, submit a declaration that the participant information, consent form and other relevant material will be translated by a qualified translator into the required language. Confirm that communication in that language will be maintained throughout the trial. The translated documents used with the participant must be approved through the applicable CTIS route before use.

Investigator suitability

Mandatory. Submit one current curriculum vitae for the principal investigator at each site under CTIS section M, Suitability of the investigator. Germany requires the CV to be no more than one year old and to include the investigator’s name, business address, current role, professional history, specialist status, relevant additional qualifications, trial experience and date. The EU Investigator Curriculum Vitae template should normally be used. A separate signature is not required for CTIS submission.

Mandatory. Submit a dated declaration of interest for each principal investigator under section M. Use the EU Declaration of Interest template and disclose economic interests, institutional relationships or personal interests that could affect impartiality. The Clinical Trials Regulation does not require a signature on this individual document.

Mandatory. Submit the principal investigator’s applicable regulatory-training certificates. From 1 July 2026, the current AKEK and German Medical Association qualification guideline applies after expiry of its transition period. The certificates are existing records and require no new submission signature.

Trial-site suitability

Mandatory. Submit one Germany Site Suitability Template for each site under CTIS section N, Suitability of the facilities. Use AKEK German version 3.22 dated 6 June 2025. Complete at least the main form for the site. The appendix is used to define role-based qualification requirements for the investigating team.

The form is issued and dated by the principal investigator on behalf of the site or organisation. The current German template states that a separate signature is not required by the Clinical Trials Regulation. It must describe the facilities, equipment, staffing, expertise, patient pool, trial tasks and any external arrangements clearly enough for site-specific assessment.

Conditional. Where trial procedures involve ionising radiation, upload the documents required under the German Radiation Protection Act in CTIS Part II section N. Since 1 July 2025, the radiation-protection application or notification is routed through CTIS with the medicinal-product trial. The exact documents depend on whether the use requires approval or notification.

Insurance or indemnification

Mandatory unless the low-intervention exception applies. Submit the insurance certificate and applicable terms in CTIS section O, Proof of insurance cover or indemnification. German law normally requires no-fault participant insurance with coverage proportionate to risk and at least EUR 500,000 for each case of death or permanent incapacity.

For a low-intervention trial, separate participant insurance is not required where another insurance arrangement covers the investigator and sponsor. In that case, submit evidence and a short explanation of the alternative cover.

The insurer issues the certificate and terms. No additional sponsor or investigator signature is required at CTIS submission. Submission proof may be in German or English, but the insurance information and conditions provided to participants must be available in German before consent.

Financial and other arrangements

Mandatory. Submit a concise description of trial financing, payments to participants, payments to investigators or sites and other sponsor-site agreements under CTIS section P, Financial and other arrangements. The EU compensation template is the recommended format. The document is dated and submitted without a separate individual signature.

Conditional. If participants receive payment, reimbursement or compensation for loss of earnings, state the amounts, payment schedule, conditions and treatment of early withdrawal. Payment must not create undue influence. For minors, incapacitated adults and pregnant or breastfeeding participants, only expenses and loss of earnings directly related to participation may be compensated.

Conditional. Provide a draft agreement or a clear description of the sponsor-site agreement when needed to explain financial or other arrangements. A fully executed clinical-trial agreement is not a standard precondition for the initial CTIS dossier unless a specific issue requires it.

Data-protection compliance

Mandatory. Submit the sponsor’s statement that data will be collected and processed in compliance with the General Data Protection Regulation and applicable German rules under CTIS section R, Compliance with national requirements on data protection. Use the EudraLex statement and include the commitment to comply with German requirements where General Data Protection Regulation opening clauses apply. If that sentence is missing, provide a separate Germany statement.

The statement is made by the sponsor or its representative. A separate wet-ink signature is not required unless a specific legal reason applies.

German participant documents must also contain the express written or electronic consent to process personal data, including health data, required by section 40b(6) of the Medicinal Products Act. This is signed when consent is obtained, not at submission.

Biological samples

Mandatory when samples are collected, stored or used. Submit the EudraLex biological-sample compliance template in the CTIS placeholder Compliance with applicable rules for biological samples. Describe how collection, storage, analysis, transfer, access and disposal comply with the protocol and applicable rules. The sponsor completes and dates the statement. No separate wet-ink signature is generally required.

Conditional. If samples or linked data will be retained for future research outside the protocol, submit a separate German information and consent document. It must be optional and independent of main-trial participation. The Germany secondary and future-use consent guide explains how to structure that choice.

Proof of fee payment

No separate fee-payment document is normally included in the Germany initial Part II package because the competent authority issues the combined fee decision. Upload proof in CTIS section Q, Proof of payment of fee only if specifically applicable or requested.

Final file-readiness check

Before submission, confirm that each file has the correct EU trial number, protocol code, Germany identifier where relevant, version, date, language and participant group. Do not add signatures that are not required. Do not submit signed participant consent forms in the application dossier.

Use the Germany patient-facing document QC checklist for the final cross-document review, or return to the Germany CTIS Part II hub for the complete English country guide set.