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must provide its own team of nurses who are properly equipped to perform the extra functions required. |
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Other considerations in selecting the type of clinical laboratory appropriate for a particular trial include (a) The geographical scope and the scale of the study: the more centers that are involved, the more will the selection of a central laboratory be favored; (b) The phase of the clinical development: generally it is considered that local laboratories are more suitable for the short turnaround time required for Phase I trials or some specialised Phase IV studies. For Phase II and III trials however, there is probably a strong preference for the use of central laboratories; (c) Previous experience with a laboratory; (d) Short-term costs and long-term cost effectiveness; and (e) The quality of the laboratory service. |
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III. Quality, Accreditation, and Data Archiving |
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In the mid-seventies the Food and Drug Administration (FDA) issued regulations defining Good Laboratory Practice (GLP) in order to ensure the quality, standard, and integrity of drug development studies in animals. Although few regulatory authorities outside the United States actually require compliance with GLP for samples assayed from clinical trials, the pharmaceutical industry in general expects compliance with the principles of GLP when carrying out trials in hospital or contract laboratories. There is no compulsion on local laboratories, whose prime concern is to diagnose ill health, to comply with GLP, and all too often difficulties are encountered by the sponsor in obtaining appropriate documentation and certification from such laboratories. |
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For contract laboratories it is expected that they will comply with the requirements of GLP and, in the United States, also participate in programs conducted by the College of American Pathologists (CAP) certification or Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification. In Europe, the EU produced a document governing the conduct of clinical trials and requested that these be conducted in accordance with Good Clinical Practice (GCP). Within this regulation it is inferred that all laboratory activities in support of clinical trials should be performed according to the principles of GLP. It is also desirable, for both investigator and sponsor, that clinical trial samples are assayed in an accredited laboratory. In Europe, a laboratory may be accredited by complying with the standards of ISO 9000, EN 45000, or standards set up by organisations within a specific country. In the United Kingdom laboratories can be accredited by the Clinical Pathology Accreditation (CPA) whose inspectors ensure that the laboratory is in compliance with CPA standards. |
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When work is performed at a contract laboratory it is important that the sponsor's quality assurance staff perform regular audits to verify consistency |
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