GCP guidelines

As defined by ICH and GCP guidelines, a subinveshgator is any individual member of the clinical trial team designated and directly supervised by the PI to perform trial-related procedures or make trial-related decisions (Sechon 1.56, p. 13). ° Examples of subinvestigators include other physicians, pharmacists, pharmacologists, nurses, and study coordinators. 

Japan has adopted the ICH GCP guidelines for clinical trials since 1997. It upholds the Helsinki Declaration to ensure the rights, welfare, and privacy of subjects are protected in clinical trials. Japan accepts foreign clinical trials, but bridiging trials may need to be performed to take into consideration effects of ethnic factors. 

The FDA will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements. (Predicate rules are preexisting regulatory requirements such as GLP, GMP, and GCP guidelines.)... 

The procedures for assuring quality of clinical trials have evolved over the past 30 years, culminating in several published guidelines. There are three key documents - the GCP guidelines of the ICH, the Code of Federal Regulations (21 CFR) of the United States and the Declaration of Helsinki. " ... 

Apart from a few minor differences, the FDA has adopted the ICH GCP guidelines. The contents of the FDA Code of Regulations with reference to the protection of human subjects, institutional review boards and investigational... 

The GCP guidelines have not always been fully applied to other biomedical research, such as some independent studies on marketed products initiated by clinicians without support from the manufacturer. The training that clinicians, scientists and technicians receive from company-based staff before and during a sponsored clinical trial adds considerably to the quality standards. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

The new GCP follows the ICH GCP guideline but there are some unique aspects added in order to cope with Japanese medical and clinical practices. Although such modifications have been made, the concept of the ICH guidelines is maintained, and this caused significant change in clinical trial practice in Japan. The main points of the changes in clinical trial practice between the old and new GCP, as well as rmique aspects of Japanese GCP and clinical trial practice are explained in the sections below. 

Currently, the agency recommends sponsors to recruit more than 10 patients at each centre, and most of the study centres are able to accommodate this number. As the overall number of clinical trials has declined because of the new GCP guidelines and unfavourable pricing rules for the new products, with limited advantage over existing products, it has become relatively easy for the sponsors to meet such requirements than before. 

The new GCP guidelines has expanded the IRB constitution and its role in the clinical trial. The IRB must consist of more than five members and must include non-medical personnel and a person who does not relate to the study centre. There are no requirements regarding the balance of gender. The head of the institute can attend the IRB meetings but cannot be a member nor discuss or vote at the meeting. 

The capture, processing, and retention of data should be carefully dehned and managed. The ICH GCP Guidelines, which recognize that clinical trial data can take many forms (paper, optical, electronic), indicate that the Sponsor has specific responsibihties regarding the handling of electronic data and the use of remote electronic clinical trial data systems (subsection 5.5.3). Snch responsibilities include ... 

The draft of GCP guidelines has been prepared in consultation with the industry and is likely to be appended to Schedule Y. 

Clinical trials should be done in compliance with GCP (Article 14 of the PAL in 1996. GCP guidelines in 1997)... 

GCP Guidelines. GCP was implemented October in 1989 in Japan. In the revised PAL in 1996, GCP was legislated and a new GCP based on the ICH GCP guidelines was enforced in April 1997. However, the following items in the new GCP did not start until April 1998 since new GCP required d5mamic changes both to investiga-tors/institutes and sponsors ... 

The main regulative guidelines for pharmaceutical products date from 25 May 1972, updated 25 November 1999. Clinical tried regulations were introduced 18 November 1993 compliant with International Good Clinical Practice (GCP) Guidelines and came into force 1 January 1995. 

Clinical research, if conducted according to good clinical practice (GCP) guidelines, is not normally considered promotional however, research that is conducted by pharmaceutical companies will usually have some impact on the commercialisation of the company s product and therefore care needs to be taken as to how this is organised. 

One of the principles of ICH GCP is that each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s) . Specifically, regarding the selection and qualifications of monitors, the ICH GCP Guideline states that monitors... 

According to ICH GCP guideline 4.9.5, records are to be retained until at least two years after the last approval of a marketing application. Records may be retained for even longer periods if required by applicable regulatory requirements or if required by the sponsor. 

An effective QM system for clinical research helps assure that studies are planned, conducted, analyzed, reported and managed in compliance with GCP guidelines and ethical principles as noted in the Declaration of Helsinki, so that dependable trial results are achieved while ensuring that trial participants are protected. 

The Clinical Trials Directive requires the integration of the GCP guidelines into the national law of all MS (which had not been the case in some MS before May 2004). Local regulatory authorities now carry the burden of inspecting for compliance with both GCP and the GMP guidelines for investigational drugs. Inspections take place at both sponsor s facilities and clinical trial sites. 

The European clinical trial directive has the central objective of protecting subjects taking part in medical research. The principles within Declaration of Helsinki (as amended) are now integrated into the legal framework by inclusion in the GCP guidelines (and also the GMP guidelines, see next section). Briefly, these principles are the following ... 

Good clinical practice (GCP) guidelines are published and should be adhered to. Normal precautions should be applied to protect the safety and health of test subjects throughout the trial, with provision for emergency treatment and effective treatment against possible adverse reactions. 

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