Good clinical practice monitor

Study monitors or clinical research associates (CRAs) can be employed by the study sponsor, CRO, or independently contracted for a specific study and, according to the International Committee on Harmonisation (ICH) and formalized by FDA in the Guidance for Industry Good Clinical Practice (GCP), the purpose of a CRA is to ... 

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. For more information on the FDA s GCP program, go to http //... 

The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research. As it is difficult to cover this broad topic in such a short chapter, the authors will focus on those areas that are most discussed, most problematic and most critical to achieving a GCP-compliant clinical study. Thus, there is particular emphasis on ethical issues, source data verification and data integrity, monitoring and safety review, and study medication/device management. 

Contract research organizations (CROs) should be inspected as part of the assessment process to verify that raw data correspond to submitted data, and to assess compliance with standards during the conduct of clinical and bioequivalence studies. Monitoring and requalification should ensure that the principles of good clinical practices (GCP) (20), good practices for quality control laboratories (10) and GLP (19) are adhered to. 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

Campbell, M. (ed.J (1996) Sensor System for Environmental Monitoring, Kluwer Academic Publishers, The Hague. Carson, P.A., and Dent, N.J. (ed.) (1990) Good Laboratory and Clinical Practices, Hememann Newnes, Oxford. Carson, P.A., and Mumford, C.J. (1988) The Safe Handling of Chemicals in Industry (Vols 1 and 2), Longman Scientific and Technical, Harlow. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

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