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Page 388 hospital, institution, or private practice where the records are stored. The European GCP guideline specifies that pharmaceutical companies, investigators, and clinical centers involved in trials must keep patient files and other source data for at least 15 years and longer if possible. The sponsor also has responsibility for retaining other documentation pertaining to the trial but clearly the area of greatest potential for noncompliance resides with the local clinical pathology laboratories. IV. Progressive Restructuring of Clinical Pathology at Zeneca to Support Clinical Trials In 1989, Zeneca's clinical pathology laboratory had a complement of 21 staff, 19 of whom were analysts working in either the blood chemistry, urinalysis, or hematology units. In that year 35,000 analytical samples were analyzed with 80% being generated from animal toxicology studies with the remaining from Phase I clinical trials. As illustrated in Figure 2, the daily workload at this time was quite variable and efficiency was compromised during periods when there were few or no samples for analysis. In order to provide a steady flow of work and to improve clinical standards it was decided that the laboratory would start to support U.K. Phase II trials, and later to expand to Phase II and III support throughout Europe. The initial trials went well, with the laboratory following a steep learning curve, and by the end of 1991 the laboratory had supported 12 single-center and 5 multicenter trials in 5 European countries. As displayed in Table 1 and Figure 3, clinical trial support rapidly increased such that, by 1995, of the 71,000 samples analysed 53% were human samples submitted by 967 clinical trial centers located in Table 1 Growth in Clinical Pathology Workload in Support of Clinical Trials (19901995) 1990 1991 1992 1993 1994 1995 Clinical workload as a percentage of laboratory total 20.8% 39.5% 50.2% 70.3% 73.6% 52.8% Laboratory total workload (samples/yr) 39,250 46,113 58,405 75,961 84,599 71,170 Total number of centers supported during the year 9 47 325 450 753 967 Total number of countries 1 5 15 17 18 20
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