Ireland CTIS Part II Document Checklist

Required and conditional Part II documents

Recruitment and informed consent procedure

Mandatory. Complete the EU Recruitment and Informed Consent Procedure template in English for every trial. Upload it under the CTIS recruitment arrangements section. Version 2.0 is strongly recommended on 31 August 2026 and becomes the operative format for new Part II submissions on 1 September 2026. It covers recruitment, ordinary consent, incapacitated adults, minors, impartial witnesses and emergency enrollment. It is not signed at submission.

Describe how people are identified, the first act of recruitment, who makes the initial approach, whether medical records or patient lists are accessed, how privacy is protected and who provides information and takes consent. In Ireland, the person conducting the pre-consent interview and taking consent may be the investigator or an appropriate registered medical practitioner, dentist or nurse designated by the investigator.

Recruitment materials

Conditional. Submit every advertisement, letter, brochure, social-media item, video script, website text or other material that will be shown to potential participants. Upload final English versions under recruitment arrangements. These documents are not signed. The recruitment procedure must explain how each item is used and how responses from people who are not eligible will be handled.

Subject Information Sheet and Informed Consent Form

Mandatory when participants are enrolled. Submit the blank English Subject Information Sheet (SIS) and Informed Consent Form (ICF) under subject information and informed consent. They are not signed at CTIS submission. The participant or legally designated representative and the authorised person taking consent sign and date the approved form later, when consent is obtained.

Provide separate or clearly distinct versions for each population and optional procedure that changes the information or consent logic. This may include minors, parents or guardians, incapacitated adults, healthy volunteers, emergency enrollment, pregnant participants, pregnant partners, optional genetics, future research and other substudy consent. The Ireland patient information and consent guide explains the core document.

Other participant-facing materials

Conditional. Submit diaries, questionnaires, participant cards, electronic-interface text, videos, instructions, letters and other material shown to participants when it affects their understanding, decisions or trial burden. Use final English versions. These items are normally unsigned unless the document itself records a participant choice.

Principal investigator curriculum vitae

Mandatory for each Irish site. Submit a current curriculum vitae showing the principal investigator's education, training and relevant experience under suitability of the investigator. The EMA or equivalent NREC-aligned format is accepted. Complete the name, site and date fields. The CTR does not itself require a signature on each application document, and Ireland has not published a separate wet-ink signature rule for the CV.

Irish legislation requires an investigator to be a registered medical practitioner or registered dentist. Make the professional registration and clinical-trial experience clear in the CV.

Principal investigator declaration of interest

Mandatory for each Irish site. Submit a trial-specific declaration of interests under suitability of the investigator. The EU template or an equivalent accepted format may be used. It must identify any economic, institutional or personal interest that could affect impartiality. Complete the investigator, institution and date fields. The EU template states that the CTR does not require the individual document to be signed.

Irish Site Suitability Form

Mandatory for each Irish site. Use the current NREC-CT Site Suitability Form, not only the generic EU form. Upload one completed form per site under suitability of the facilities. It must describe the site, facilities, equipment, procedures, staffing, expertise, pharmacy arrangements and any site-specific issues such as ionising radiation.

Complete the issuer, position, organisation and date fields and follow the authorisation field in the current national form. Make the planned participant number consistent with CTIS and the Irish site list. Site forms are a frequent source of avoidable inconsistencies.

Proof of insurance or indemnity

Mandatory. Submit a valid insurance certificate or evidence of an appropriate indemnity arrangement under proof of insurance cover or indemnification. The cover must be appropriate to the nature and extent of trial risk and provide compensation for damage resulting from participation. The document is issued by the insurer or indemnity provider and is not signed by the participant.

For trials involving delegated State authority healthcare enterprises and academic institutions, check the current State Claims Agency guidance and Clinical Trial Indemnity Form. Commercial arrangements may also use the standard Irish documents developed with the State Claims Agency, HSE and the Irish Pharmaceutical Healthcare Association.

Compensation and reimbursement for participants

Mandatory as a disclosure, even when no payment is offered. Use the EU compensation template or the accepted equivalent under financial and other arrangements. State whether participants, parents, carers or legal representatives receive travel, meals, accommodation, loss-of-earnings reimbursement, money or non-monetary items. The document is not signed at submission.

The SIS and ICF must match the compensation document. For minors, incapacitated adults and breastfeeding women, incentives are prohibited, apart from reimbursement of expenses or loss of earnings directly related to participation. Any small token of appreciation needs ethics review.

Other financial arrangements

Mandatory where applicable. Describe financing, payments to investigators and sites, and other agreements that could affect impartiality. A contract does not need to be uploaded unless the requested information is not otherwise provided or NREC-CT asks for it. Ensure financial statements, the participant documents and reimbursement process agree.

NREC Statement of Compliance or Data Protection Impact Assessment

Mandatory. Use the current NREC Statement of Compliance regarding Data Protection, version 2 at the review date, or provide a Data Protection Impact Assessment instead. Upload it under compliance with national requirements on data protection. A generic EU GDPR statement does not replace this Irish requirement.

The document must identify controllers, processors, recipients, lawful bases, Article 9 condition, Irish Health Research Regulations safeguards, retention, transfers, security, participant rights and Data Protection Officer input. Follow the current template's completion and authorisation fields. The Ireland patient-facing QC guide helps align these details with the SIS and ICF.

Compliance with rules for biological samples

Conditional. Submit the EU biological-samples template or accepted NREC equivalent if the trial collects, accesses, stores, transfers or plans future use of human biological samples. Upload it under compliance with applicable rules for biological samples. It is not signed at submission unless the selected current form includes an authorisation field.

Describe sample type and volume, collection, legal responsibility, analysis, storage location and duration, coding, access, transfers, destruction and any future use. Optional future use must also be explained to participants and supported by valid consent. The Ireland secondary-use consent guide explains the Irish limits on broad consent.

Ireland fee evidence

Mandatory for fee-paying applications, but not a Part II ethics document. Commercial sponsors pay the Irish clinical-trial fee to HPRA and submit proof of payment and the completed HPRA fee application form in CTIS. Non-commercial and academic trials are not charged. Keep this administrative item in the correct CTIS area rather than misclassifying it as a Part II ethics document.

Submission checks that prevent avoidable RFIs

• Use English for every Irish document and communication.
• Use the current NREC Site Suitability Form for every site.
• Use the current NREC Statement of Compliance or provide a DPIA.
• Use Recruitment and Informed Consent Procedure template version 2.0 for new submissions from 1 September 2026.
• Match Irish site names, investigator names and participant numbers across CTIS and every form.
• Keep insurance dates valid for the planned trial period and explain renewal where cover expires earlier.
• Match compensation, travel and third-party reimbursement details across the financial form and participant documents.
• Keep sample storage, data retention, recipients, transfers and withdrawal wording consistent across the protocol, SIS and ICF, data statement and biological-samples form.
• Submit accessible, searchable Word files or original PDFs. Avoid scanned image-only documents.
• Confirm that every population or optional procedure has the correct information and consent document.

The Ireland CTIS hub links to the detailed consent variations used in this checklist.