Germany CTIS Patient-Facing Document QC Checklist

1. Trial content checks

Confirm that each document uses the current:

• protocol title, code, EU trial number, version, and date
• sponsor and site information
• investigational and comparator treatments
• study purpose, phase, and participant population
• randomization ratio, treatment groups, placebo, and blinding
• visit schedule, duration, procedures, tests, and follow-up
• number and volume of samples
• participant restrictions and prohibited treatments
• expected benefits and treatment alternatives
• reimbursement, compensation, insurance, and contacts

Remove statements carried over from another protocol, country, cohort, or study phase.

2. Protocol-to-participant-document consistency checks

Compare the documents line by line with the protocol, investigator's brochure, risk section, pharmacy information, data-flow description, sample plan, and insurance evidence.

Check especially that:

• every research-only procedure is visible to the participant
• risk frequency and severity are not softened
• pregnancy testing and contraception periods match the protocol
• treatment interruption and withdrawal rules match the protocol
• optional procedures are not described as mandatory
• planned remote visits, electronic consent, home nursing, wearables, or direct-to-participant shipment are explained
• the insurance wording matches the certificate and policy terms
• the data and sample retention periods are consistent across documents

If the protocol changes, reopen every affected participant document. Do not update only the main adult form.

3. Consent logic checks

Confirm that:

• the main participation decision is separate from optional choices
• express consent to processing personal and health data is present
• optional future use, genetics, additional sampling, re-contact, and pregnancy follow-up have separate choices where required
• refusal of an optional activity does not block main-study participation unless scientifically necessary and justified
• withdrawal language explains both the right to stop and the lawful limits on deleting already collected data
• the person signing has legal authority for the decision
• the participant and physician signature order and timing are clear
• a signed copy is provided to the participant or representative
• re-consent triggers are defined for new information, new versions, regained capacity, or reaching adulthood

The Germany patient information and consent guide gives the default capable-adult logic.

4. Population and document coverage checks

Map every inclusion pathway in the protocol to an information and consent set.

Healthy volunteers

Confirm that the document says no therapeutic benefit is expected, explains early-phase uncertainty where relevant, and states restrictions, payment, contraception, and confinement accurately. Use the Germany healthy-volunteer consent guide

Minors

Confirm legal-representative consent, age and maturity-appropriate information, the capable minor's additional written consent, dissent, and re-consent at age 18. Use the Germany minor consent and assent guide

Adults without capacity

Confirm representative authority, adapted participant information, objection handling, capacity reassessment, and the special German advance-consent condition for group-benefit research. Use the Germany limited-capacity and legal-representative guide

Emergency enrollment

Confirm every Article 35 condition, the absence of known objection, investigator certification, later information and consent, and the right to object to use of data. Use the Germany emergency enrollment guide

Participant unable to write

Confirm that physical inability to sign is not confused with lack of capacity. Add the alternative-recording method and impartial-witness signature block. Use the Germany impartial witness guide

Pregnancy follow-up

Confirm whether the person is a pregnant participant or the pregnant partner of a participant, whose medical records are accessed, which infant data are collected, and whose consent is required. Use the Germany pregnancy follow-up guide

Secondary or future use

Confirm that research outside the protocol is optional and supported by a separate information and consent document. Use the Germany secondary-use consent guide

5. Data-privacy checks

Confirm that the German documents identify and explain:

• the controller and data-protection contact
• categories of personal and health data
• each processing purpose
• coding or pseudonymization and where the key is held
• direct access by monitors, auditors, inspectors, and authorities
• recipients and transfers to sponsor, processors, authorities, and regulatory applicants
• safety reporting and CTIS reporting
• transfers outside the European Economic Area and the applicable safeguards or risks
• retention periods
• participant rights and practical contact route
• withdrawal and the German rules allowing necessary continued processing
• express written or electronic health-data consent under section 40b(6) of the Medicinal Products Act

Check that privacy language does not promise anonymity where coded data are used and does not promise deletion that would conflict with safety, scientific-integrity, or regulatory duties.

6. Biological-sample and secondary-use checks

For every sample, confirm:

• sample type, volume, frequency, and timing
• protocol purpose and planned analyses
• whether genetic testing is involved
• coding, storage location, duration, and responsible organization
• transfers and recipient categories
• exhaustion, return, or destruction
• treatment of incidental findings where applicable
• whether commercial research is possible
• withdrawal options and practical limits
• clear separation of protocol use from optional use outside the protocol

If samples or associated data will be used outside the clinical-trial protocol, verify the separate optional document required by AKEK guidance.

7. Germany-specific regulatory checks

Confirm that:

• all participant and representative documents are in German
• any planned non-German enrollment has qualified translations and a communication plan
• the appropriate AKEK adult patient or healthy-volunteer model was considered
• the physician-led information process matches section 40b(2)
• trial-participant insurance wording matches German coverage
• vulnerable-population pathways match sections 40b(3) to 40b(5)
• the data section contains every disclosure in section 40b(6)
• recruitment material avoids promotional claims and undue emphasis on payment
• endpoint-related patient-facing documents follow the current Part I and Part II translation route
• radiation information and Part II documentation are included where the 2025 German radiation route applies

8. Signature, version, and administrative checks

For every file, verify:

• correct document title, population, language code, version, and date
• matching version references inside the consent form
• no participant, representative, or physician signature in the blank CTIS submission copy
• complete signature and date fields for use at consent
• witness fields only where the alternative-signature pathway can apply
• representative capacity or relationship field where relevant
• page numbering and a place for participant initials only if the process requires it
• a statement that the participant receives a signed copy
• correct CTIS section and naming convention
• removal of personal data that should not appear in the CTIS upload

9. Readability, language, and design checks

Ask a reviewer who did not draft the document to confirm that:

• the first pages answer what the trial is, what happens, the main risks, and available alternatives
• sentences are short and medical terms are explained
• risks are grouped and prioritized
• numbers, probabilities, visit counts, and time periods are easy to find
• headings make the document easy to scan
• optional choices look optional
• the consent form does not introduce information absent from the information sheet
• German terminology is consistent and natural
• translations were reviewed by a qualified person and match the approved source
• formatting remains usable when printed, viewed on a phone, or used electronically

10. Final package check

Compare the file list with the protocol's population, country, site, procedure, data, and sample matrices. Then compare it with the Germany CTIS Part II document checklist

Return to the Germany CTIS submission guide hub for the complete guide series.

Other language versions

Read this guide in German.