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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Good Clinical Practice
Training requirements to maintain international standards for clinical trials.
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Exempt processes
Processes for investigational medicines that don't require a manufacturer's authorisation
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GCP inspections
Serious breach reporting, informed consent, and electronic health records (eHRs)
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Contact information
Contact details for several bodies involved in clinical trials in Ireland
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