Ireland CTIS Patient-Facing Document QC Checklist

1. Document inventory and version control

• Every patient-facing item appears in the Part II document inventory.
• Each document has a distinct title, version and date that match its CTIS entry.
• Clean and tracked versions are clearly identified where both are supplied.
• Site-specific contact details and local procedures are complete.
• Superseded versions have not been uploaded by mistake.
• The footer is consistent and does not reveal editing comments or internal filenames.
• The document can be searched, copied and read with assistive technology. Do not submit image-only scans as source documents.

2. Population and consent-pathway coverage

Confirm that every population permitted by the protocol has an appropriate information and consent route.

• Adults who can consent use the main SIS and ICF.
• Healthy volunteers receive information tailored to non-therapeutic participation. See the healthy volunteer guide.
• Participants under 16 have guardian consent and age-appropriate assent materials where capable. See the minor consent and assent guide.
• Adults unable to consent have the correct legally designated representative pathway. See the limited-capacity guide.
• Emergency enrolment is used only where the protocol and law allow deferred consent. See the emergency enrolment guide.
• A witness pathway is included only where it may be needed. See the impartial witness guide.
• Pregnancy follow-up has separate, appropriate information and consent for the participant or pregnant partner. See the pregnancy follow-up guide.
• Optional future research is separated from trial participation. See the secondary-use guide.

3. Protocol consistency

Check every statement against the final protocol and other Part II forms.

• Trial title, sponsor, phase, purpose and treatment allocation agree.
• Visit number, visit length, study duration and follow-up period agree.
• Procedures, sample volumes, imaging, biopsies and optional substudies agree.
• Randomisation, placebo and blinding are described accurately.
• Foreseeable risks, burdens, reproductive precautions and expected benefits agree.
• Rescue treatment, prohibited medicines and lifestyle restrictions agree.
• Early withdrawal and sponsor termination consequences agree.
• Pregnancy reporting and follow-up routes agree.

Do not repair a protocol conflict only in the participant document. Resolve the source discrepancy and update all affected files.

4. Required participant information

Verify that the information sheet explains in plain English:

• that the activity is research and participation is voluntary
• why the person is invited and how many people will take part
• what will happen, what is experimental and what differs from normal care
• reasonably foreseeable risks, discomforts and disadvantages
• expected benefits, including a clear statement if there may be no personal benefit
• relevant alternative treatment or care
• compensation, reimbursement, insurance and injury arrangements
• confidentiality, access to records and data-protection rights
• biological sample collection, testing, storage and destruction or further use
• what happens if the person stops and what data may lawfully remain
• who to contact about the trial, rights, injury and data protection
• new information that could affect willingness to continue
• the applicable cooling-off or reflection opportunity where practicable

5. Consent-form controls

• Each consent statement has a corresponding explanation in the information sheet.
• Required trial participation is not mixed with optional choices.
• Optional items have separate initials, tick boxes or signatures and can be declined independently.
• Consent to record access identifies the relevant monitors, auditors, regulators and authorised bodies.
• Data and sample wording does not promise complete deletion where legal retention duties apply.
• Signature blocks cover the participant or representative, the person conducting consent, date and time where needed.
• Guardian, legally designated representative, witness and interpreter blocks appear only in the versions that use them.
• No pre-ticked boxes or bundled future-use permission appears.

6. Irish data-protection review

Cross-check the participant documents against the NREC data-protection statement, the sponsor privacy information and any DPIA.

• Controller and relevant contact details are consistent.
• Data categories, purposes, legal bases, recipients and transfers agree.
• Retention periods or the method for setting them agree.
• The documents distinguish consent to trial participation from the legal basis for processing personal data.
• Any reliance on explicit consent as a Health Research Regulations safeguard is described accurately.
• A legally designated representative is not asked to give explicit consent to data processing for an adult who lacks capacity.
• Any required Health Research Consent Declaration Committee route is identified before submission.
• Pseudonymised data are not described as anonymous.

7. Biological samples and secondary use

• Sample type, amount, collection method and immediate trial use are clear.
• Storage location, duration, access and transfer arrangements are clear.
• Genetic or genomic analysis is stated expressly where relevant.
• Optional secondary use is separate from required protocol testing.
• Broad consent is limited to a described disease, health or research area. It is not permission for unspecified research.
• Withdrawal consequences explain what can and cannot be retrieved or destroyed.
• Future projects will receive the required ethics and governance review.

8. Readability, accessibility and tone

• The intended participant can understand the document without specialist knowledge.
• Sentences are short and technical terms are defined on first use.
• Risk is expressed consistently using words and numbers where useful.
• Headings, lists, spacing and page numbering support navigation.
• Tables do not hide essential information.
• Instructions do not pressure the participant or imply loss of ordinary care for refusal.
• Payment wording does not suggest that payment is a benefit of treatment.
• The document uses respectful, person-centred language.

Ireland requires the application and trial communications to be in English. If a participant needs another language or communication format, plan an approved translation or accessible process without implying that an unpublished Irish-language CTIS guide is available.

9. Final cross-document review

Compare the final participant set with the protocol, investigator brochure or product information, recruitment procedure, recruitment materials, site suitability form, compensation form, insurance certificate, Irish data statement and biological-sample form. Record each discrepancy, its owner and its resolution.

Run a final check of all hyperlinks, telephone numbers, email addresses, version dates, document names and signature fields. Then review the uploaded CTIS files rather than relying only on the local folder.

Return to the Ireland CTIS Part II guide hub for the complete national series.