To ensure that new medicines were developed according to comparable standards, regulatory authorities and pharmaceutical industry associations from the USA, the European Union and Japan created the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 1990.
In 1996, the ICH adopted a guideline for Good Clinical Practice (ICH-GCP) which has become the worldwide gold standard for clinical research with pharmaceuticals and biologicals. Its key points are again to ensure the protection of trial participants and the quality of trial data. ICH-GCP provides more detailed rules on the conduct of clinical trials.
The guideline describes responsibilities of the Independent Ethics Committee, the investigator (the physician who performs experimental treatments) and of the sponsor (the person or institution, who apart from financing is responsible for trial design, organisation and data evaluation).
Ethics Committees (or Independent Review Boards in the US) receive guidance about their composition i.e. number of members and backgrounds, and the documents and aspects of the trials that should be reviewed before giving an ethical decision. The sponsor must receive documented approval for the study by both the Ethics Committees and the Competent Authority where the trial is to be conducted, before allowing any subjects to be dosed with the new investigational product.
GCP have their origins in the Nuremberg Code and more recently in the Declaration of Helsinki for which the basic principles included the obtaining of “informed consent” i.e. the idea that participation of a person in medical experiments is only acceptable if the person has been informed about the concept and risks of the trial and has agreed to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Trial investigators are expected to follow the approved written protocol and documented study procedures, and to respect the rights of the participants. Therefore, they can only participate in a trial, if they have adequately qualified and trained staff, and if they have appropriate equipment as required for a particular study.
The sponsor has the obligation to monitor the trial, i.e. to send out qualified personal, also named Clinical Research Associate, to verify at the investigator’s site (normally a hospital or a general practice) if the protocol has been followed, and if the data sent to the sponsor corresponds to the data documented at the site.
For more information, please read the following document: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf