Clinical Trials involving Medicinal Products

Clinical Trials involving Medicinal Products are covered by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004) (S.I. 190 of 2004) as amended which implement the EU Clinical Trials Directive (2001/20/EC). The Regulations set out measures relating to the conduct of clinical trials on medicinal products for human use. They replace those controls that previously applied to such trials under the Control of Clinical Trials Acts, 1987 and 1990.

Aspects dealt with in the Regulations include:

  • procedures for obtaining a favorable ethics committee opinion (a single ethics committee opinion is required in the case of multi-center trials);
  • procedures for obtaining authorizations for the conduct of clinical trials from the Health Products Regulatory Authority;
  • controls that are to apply to the manufacture, supply and importation of investigational medicinal products;
  • obligations for the reporting of various adverse events encountered in subjects participating in clinical trials, including the recording, reporting and notifying of such events;
  • obligations for compliance with standards of good clinical practice (GCP) and good manufacturing practice (GMP).

The Regulations contain provisions for the establishment of, recognition of and operation of ethics committees. These committees are required to be independent, consisting of healthcare professionals and lay members and to have responsibility to protect the rights, safety and wellbeing of human subjects involved in a trial. They are also required to provide a public assurance of that protection by, among other things, expressing an opinion on the trial protocol, on the suitability of the investigators, on the adequacy of the facilities, on the availability of insurance, indemnity or compensation and on the methods and documents to be used to inform trial subjects and to obtain their informed consent.

General Documents

EU Documents

National Legislation

Relevant Statutory Instruments are as follows :