Ireland CTIS Part II Guides

Ireland CTIS guide directory

1. Ireland CTIS Part II Document Checklist explains which documents belong in the Irish dossier, when each applies and which national or EU template to use.
2. Ireland Patient Information and Consent Requirements covers the main Subject Information Sheet and Informed Consent Form, including Irish language, consent and data-protection expectations.
3. Ireland Patient-Facing Document QC Checklist provides a final consistency and country-compliance review before CTIS submission.
4. Ireland Healthy Volunteer Consent Requirements explains the additional information needed when participants are healthy volunteers.
5. Ireland Minor Consent and Assent Requirements explains Ireland's age of legal competence, guardian consent, assent and re-consent at age 16.
6. Ireland Limited-Capacity and Legal Representative Consent Requirements covers Ireland's legally designated representative hierarchy and the separate rules for processing personal data.
7. Ireland Emergency Enrollment Consent Requirements explains the conditions for emergency inclusion and the required deferred-consent process.
8. Ireland Impartial Witness Consent Requirements explains when a witness is used, what the witness does and why a witness cannot consent for the participant.
9. Ireland Pregnancy Follow-Up Consent Requirements distinguishes follow-up of a pregnant participant from follow-up of a pregnant partner.
10. Ireland Secondary Use Consent Requirements explains optional future use of data and samples under Ireland's Health Research Regulations.

Main national differences in Ireland

English is required throughout

Ireland requires the application and all documents and communications before, during and after the trial to be in English. Participant-facing documents therefore need an English version suitable for the intended Irish population. Other language versions can be offered to individual participants where needed, but they do not replace the English Irish submission set.

NREC-CT reviews the country dossier

NREC-CT reviews participant information, consent, recruitment, investigator and site suitability, insurance, financial arrangements, data protection and biological samples. Documents and responses relating to an application under assessment should be sent through CTIS, not directly to HPRA or the National Office unless requested.

Two Irish templates need special attention

The Site Suitability Form must use the current NREC template for each Irish site. For data protection, the current NREC Statement of Compliance must be used unless a Data Protection Impact Assessment is provided instead. The National Office states that the EMA or NREC templates are accepted for the remaining Part II documents.

Legal competence for regulated trials begins at 16

Irish clinical-trial legislation defines a minor as a person under 16. A participant aged 16 or older can consent to the regulated trial and to processing of their data for that trial. A parent or guardian consents for a participant under 16, while the child's assent must also be sought when the child can form an opinion and assess the information. The Ireland minor consent and assent guide explains the document pathways.

Incapacity creates a separate data-protection pathway

An Irish legally designated representative can consent to trial participation for an incapacitated adult. That representative generally cannot provide the participant's explicit consent for personal-data processing under the Irish Health Research Regulations. A Health Research Consent Declaration may therefore be needed unless a specific exemption, including the tightly defined deferred-consent route, applies. The Ireland limited-capacity consent guide separates these two permissions.

Other language versions

This directory lists only published Ireland guides in English. An Irish-language hub should be linked here only after the corresponding Irish-language guide set is published and its URLs have been checked.