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C. Patient Review and Database Management |
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The laboratory acts as an initial sieve to identify any major clinical pathology changes. In addition to reviewing every report, electronic flags can be set against key parameters, specific to each therapeutic area, allowing immediate action to be taken to inform the appropriate individuals. A quick response is always important on such occasions and the information is phoned or faxed immediately. Follow up review can be easily arranged and the flexibility of the laboratory computer allows additional related information to be extracted quickly. As confidence in the laboratory has grown over the years, more and more responsibility for identifying important changes in the data is placed with the laboratory personnel reviewing the results. |
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Early identification of errors and inconsistencies in patient demography details and the pro-active approach adopted to resolve these issues, ensures that errors are quickly corrected. The ease of communication within the company, both at headquarters and with the European Pharmas, ensure that issues are addressed and resolved within days. Joint Working Practice Procedures have been agreed on between the laboratory and Medical Function personnel, including the Pharma CRAs. These standard procedures avoid confusion and the documents related to data amendments are fully covered by the procedures and comply with GCP. All clinical pathology requests are completed in triplicate, a copy of each form being retained by the investigator. Each CRA will check the accuracy of these requests during their center monitoring visit and also retain a copy. Any patient demographic amendments must carry the investigator signature before they can be actioned by the laboratory. Any other type of amendment must be substantiated by the CRA using validated documentation. Although, apparently labor intensive, the procedure ensures accuracy and thus avoids any unnecessary and unwelcome delays at the end of the trial. |
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Although somewhat behind our American colleagues, the way clinical trials are supported in Europe has changed significantly over the past few years. The trend is clearly away from the use of local laboratories towards multicenter multinational trials supported by large central laboratories providing world-wide uniformity in data management and analytical procedures. Expansion of these central laboratories into regions beyond the continents of Europe and America is set to continue, allowing clinical trials to be run on a truly global basis. Global databases, holding all laboratory data for a clinical trial, will soon be the norm and it is likely that those CROs with a global presence will be the |
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