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Clinical trial sponsors

Clinical Trials Regulation

Resources for complying with the Clinical Trials Regulation and using CTIS

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Publication of clinical trial information

Information for sponsors publishing summaries of clinical trial results

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Applications under the Directive

Apply for an amendment to a trial authorised under the Directive

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Contact information

Contact details for several bodies involved in clinical trials in Ireland

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Exempt processes

Processes for investigational medicines that don't require a manufacturer's authorisation

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Safety reporting

Submit annual safety templates and report SUSARs

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GCP inspections

Serious breach reporting, informed consent, and electronic health records (eHRs)

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