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(a) Avoiding poor phlebotomy kits; ideally these should be bar coded so that no labeling of tubes is required and the kits should come pre-prepared. In addition to including labels, the instructions of what should be done with the samples should be in the form of an investigator study handbook. |
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(b) Pre-printed transport forms should be provided and easy phoning arrangements made. |
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(c) Storage of supplies can be a problem if the investigator is involved in several trials: consider the phased delivery of supplies. |
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(d) Provide legible results with reference ranges and clear out-of-range flagging on forms that can go directly into a CRF without the need to transcribe the data. |
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(e) A 24-hour, toll-free telephone number into the laboratory should be provided so that the investigator can phone if there are any problems. |
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(f) Good pretrial planning is essential and, ideally, the center coordinator or trial nurse should be involved in addition to the trial investigator. |
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XI. Laboratory Relationships and Data Management |
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A. Effective Relationships Within Zeneca |
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The successful management of Zeneca clinical trials depends on good working relationships between the laboratory and other Zeneca personnel involved with clinical trial management. |
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Good working relations have been established with two key operational groups, CRAs and Data Associates. Regular meetings, laboratory tours, and training sessions all help to build and maintain mutual confidence and understanding. The close proximity of the laboratory to the Medical Function allows the rapid resolution of queries and personal contact avoids most misunderstandings. Good communication and direct access to clinicians, therapeutic team leaders, and biometricians help the processes of agreeing on the trial protocol, maintaining awareness of key events during a clinical trial, trial progress, and laboratory result or reference range queries. |
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As diagrammatically displayed in Figure 11, the laboratory is centrally placed and is a focus for effective communication at key stages of clinical trials. A considerable amount of time and effort is devoted to maintaining good working relationships. |
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B. Effective Relationships Within Europe |
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Zeneca Pharmaceuticals has 8 major Pharma offices and a further 10 smaller Pharmas located throughout Europe. Each of these Pharma offices have Medical |
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