Germany CTIS Part II Document Checklist

Recruitment arrangements

1. Recruitment and informed-consent procedure

Mandatory. Submit a clear description of how potential participants are identified, approached, informed, given time to decide, and consented. Explain who conducts the consent interview and how capacity, vulnerable populations, remote elements, interpreters, and re-consent are handled when relevant. Administrative procedure text may be in German or English.

No signature is required on this document at CTIS submission. Germany recommends the EudraLex template. Version 2.0 applies to new Part II submissions from 1 September 2026, including initial applications, additional Member States and Part II submissions completing an Article 11 application. Use CTIS document name K1_Recruitment arrangements.

2. Recruitment material

Conditional. Submit each advertisement, poster, social-media item, script, website view, audio or video text, and other material used to recruit participants. Material shown to German-speaking candidates must be in German. It is submitted in final blank form and is not signed.

German recruitment material should identify the study clearly without promotional claims about the medicine or site. Payment should not dominate the message. If a call center is used, identify its role and submit the call script. Use CTIS document name K2_Recruitment material_[description].

Participant information and consent

3. Patient Information Sheet and Informed Consent Form

Mandatory. Submit the blank German Patient Information Sheet or Subject Information Sheet and Informed Consent Form for each population that can enter the trial. The set may include capable adult patients, healthy volunteers, minors, parents or guardians, adults without capacity, and emergency follow-up documents.

These forms are not signed at CTIS submission. When consent is obtained, the participant or legally designated representative and the physician who conducts the consent interview sign and date the consent in writing or through a compliant electronic process. A copy is provided to the participant or representative. Use a descriptive CTIS name such as L1_SIS and ICF_adult patients_DE.

The Germany patient information and consent guide explains the standard adult document. Use the linked population guides where the standard pathway does not apply.

4. Other information given before the participation decision

Conditional. Submit any additional leaflet or information material given with the consent package before the person decides whether to participate. It must be in German for German-speaking participants and should be submitted in final blank form without participant signatures. Use L2_Other subject information material_[description]_DE.

5. Translated patient-facing endpoint documents

Conditional. Questionnaires, diaries, participant cards, and similar documents related to primary or secondary endpoints belong with the protocol in Part I. For multinational trials, the English source is submitted in Part I and the required German translation is submitted in Part II. The June 2026 Member State overview directs these translations to the R_Compliance with national requirements on data protection area. Do not upload all operational participant materials by default. Current EU guidance does not provide a basis to request every patient-facing document or every translation.

Investigator suitability

6. Principal investigator curriculum vitae

Mandatory for each site. Submit a current CV that shows professional qualification, relevant clinical experience, trial experience, and Good Clinical Practice knowledge. The current German site template asks for a professional CV no more than one year old. German or English is acceptable.

The EU CV template is recommended, not mandatory. The Clinical Trials Regulation does not itself require a separate signature on each application document. Keep a properly dated source version under the sponsor's and site's document-control process. Use M1_CV_[investigator]_[site].

7. Regulatory-training certificates

Mandatory for the relevant investigators. Germany expects evidence of regulatory training covering the Clinical Trials Regulation, the Medicinal Products Act, and Good Clinical Practice according to the applicable German curricular recommendations. Submit certificates current for the investigator's role. German or English is normally suitable. The certificate is issued by the training provider and does not require a further sponsor signature. Use a clear name such as M2_Regulatory training_[investigator]_[site].

8. Declaration of interest

Mandatory for each principal investigator. Disclose economic interests, institutional relationships, and other conditions that could influence impartiality. The EU declaration-of-interest template is recommended. German or English is acceptable. No additional CTIS signature should be added unless the selected form or ethics committee specifically requires it. Use M2_DoI_[investigator]_[site] under the current CTIS naming convention.

Site suitability

9. Site-suitability statement

Mandatory for each site. Describe why the facilities, equipment, staffing, emergency arrangements, pharmacy and laboratory support, participant population, and investigator team are suitable for this protocol. Use the current AKEK Germany site-suitability template or an equivalent that covers Annex I, point 67.

The head of the institution or an authorized delegate approves the statement internally. AKEK instructs applicants not to include the signature itself in the CTIS-uploaded version. German or English is acceptable. Use N1_Site suitability form_[site].

10. List of trial sites

CTIS N2.

Mandatory. Ensure that CTIS contains the planned German sites, principal investigators, roles, and planned participant numbers. If a separate list is used, submit it in German or English without signatures under the suitability-of-facilities area using a clear file name.

11. Radiation documentation

Conditional. If the trial includes medical exposure to ionizing radiation or radioactive substances that requires a German authorization or notification, follow the route in force since 1 July 2025. Documents required for an authorization under section 31 of the Radiation Protection Act are uploaded in Part II under N_Suitability of Facility. The exact file set depends on the radiation procedure. Confirm the BfArM or PEI route before submission.

Insurance and indemnification

12. Trial-participant insurance certificate

Mandatory unless the statutory low-intervention exception applies. German law requires no-fault trial-participant insurance proportionate to the risk, with at least EUR 500,000 available for each case of death or continuing incapacity for work. A low-intervention trial may rely on other insurance only where the German statutory conditions are met.

Submit the insurer-issued certificate and ensure that it identifies the trial or clearly establishes coverage in Germany. German or English may be used for the submission document, but the participant information must explain the cover in German. No sponsor signature replaces the insurer's evidence. Use O1_Trial participant insurance certificate.

13. Insurance terms and conditions

CTIS O2.

Mandatory with the German insurance evidence where needed to assess coverage. Submit the applicable policy terms and conditions in German or English. The participant document should state the insurer, policy or reference number, contact route, main cover, and any participant obligations that affect a claim. Use a clear name under O_Proof of insurance or indemnification.

Financial and other arrangements

14. Participant compensation and reimbursement

Mandatory as a statement. Explain travel reimbursement, expense reimbursement, inconvenience payments, prorating, and any other payment. State clearly when no payment is offered. The EU compensation template is recommended in Germany. German or English is acceptable and no signature is normally required at submission. Use P1_Compensation trial participants, investigator, funding and other arrangements.

15. Sponsor-site contract and other financial arrangements

CTIS P2.

Conditional. Submit the draft contract between the sponsor and each German site when it contains the financial and operational arrangements assessed under Part II. Include other relevant agreements or a description of funding where applicable. A draft is submitted without site or sponsor signatures unless the ethics committee requests otherwise.

Data protection

16. GDPR and national data-protection compliance statement

Mandatory. Submit the EudraLex GDPR statement or an equivalent statement confirming compliance with Regulation (EU) 2016/679. For Germany, the statement should also confirm that national data-protection rules will be respected where GDPR opening clauses apply. If the national point is not included in the common statement, submit a separate Part II document.

German or English is acceptable. No separate signature is required by the Clinical Trials Regulation. Use R1_Compliance on the collection and use of personal data.

The participant consent itself must also contain Germany's express consent to processing personal data, especially health data, and the disclosures required by section 40b(6) of the Medicinal Products Act.

Biological samples

17. Compliance with the use of biological samples

Conditional. Submit the EudraLex biological-samples form when the trial collects, stores, uses, or transfers human biological samples. Describe protocol use, storage, transfers, destruction or return, and any planned use beyond the protocol. The EU form is recommended in Germany and may be completed in German or English. It is not signed at submission unless a selected local form requires it. Use S1_Compliance on the collection, use and storage of biological samples.

Optional use outside the protocol needs a separate consent pathway in Germany. The Germany secondary-use consent guide explains when that document must be separate from the main study consent.

Proof of fee and CTIS form items

The proof-of-fee field is in the CTIS Forms section rather than Part II. Under German law, the federal authority levies a combined fee that includes the ethics-committee fee. Follow the authority's invoicing instructions and upload proof or invoice details only when the procedure requires it.

Population-specific documents

Add a document set whenever the protocol can enroll a population that cannot use the standard capable-adult consent route:

• Healthy volunteers: separate healthy-volunteer information and consent.
• Minors: representative information and consent, age-appropriate information, and the minor's written consent when the minor has the required understanding.
• Adults without capacity: representative information and consent, adapted participant information, and any German advance-consent evidence required for group-benefit research.
• Emergency enrollment: emergency procedure description and later participant or representative information and consent documents.
• Participant unable to write: consent form with the appropriate alternative-recording and impartial-witness section.
• Pregnancy follow-up: separate documents when maternal, partner, outcome, infant, or medical-record data are not covered by the main study consent.

The Germany patient-facing document QC checklist can be used as the final cross-document review.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub links to every document and population guide in this series.

Other language versions

Read this guide in German.