Latest Information

Publications

• Clinical Trial - application forms
• Guide to Clinical Trial Applications
• Clinical Trial Sub-committee meeting dates and application cut-off dates for 2009 and 2010
• Terms of reference and rules of procedure of the Clinical Trials Subcommittee
• Payment of Fees Instructions

Legislation

• Clinical Trials On Medicinal Products For Human Use (Amendment) Regulations 2009 S.I. No 1 of 2009

FAQs

• What types of clinical trial adverse event / reaction reports should be submitted to the Clinical Trials Unit?
• Is any additional information required by the IMB when submitting clinical trial adverse event / reaction reports?
• Can fatal or other serious outcomes, which are primary efficacy endpoints, be reported in a blinded manner?
• Should SUSAR reports be unblinded prior to reporting?
• What are the timelines for reporting suspected unexpected serious adverse reactions (SUSARs)?

Events

• GCP Information Seminar