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A simple check-list may help to avoid the major problems and it is important that all systems are running smoothly before the trial starts. |
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1. Getting Samples to the Central Laboratory |
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(a) What are the courier arrangements? |
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(b) Does the investigator need a centrifuge and are there any potential problems with blood sampling (e.g., in France)? |
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(c) Are there standardized request forms; are they easy to use; are they barcoded? |
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(d) What are the laboratory's policy about sample packs and expiry dates; are they replaced automatically or by request? |
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(e) If samples are to be transported frozen will the laboratory provide dry ice and appropriate shipping materials and guidelines to ensure that the samples are still frozen when they arrive at the laboratory? |
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(f) Will the laboratory arrange training for the study nurse to explain the importance of sample collection, packaging, shipment, and documentation? |
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2. Sample Analysis at Central Laboratory |
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(a) Quality work should be assumed but inspect the laboratory, request quality control records for assays to be utilized in the trial, particularly specialized tests. During the trial request regular updates. |
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(b) Does the laboratory have efficient specimen handling procedures; timely data access and acceptable turnaround time? |
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(c) Check the test capability of the laboratory. If some work is to be subcontracted will the additional sample transport have an impact on the quality and speed of response, i.e., additional sample degradation? |
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(d) Does the laboratory have a global presence; if so, is there consistency in testing methods among sites and over time? |
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(e) For each parameter included in the trial protocol the sample stability period should be discussed with the central laboratory. For those parameters (e.g., bicarbonate; blood gases or ESR) which show biological stability for only a few hours, what arrangements have been made to analyse the samples near the investigator site? |
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(a) Agree on the format to be used. |
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(b) Agree on units and reference ranges and ascertain how these are determined. |
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(c) What are the procedures for abnormal results, are there abnormal flagging conventions; how do they track and highlight patients whose results go outside stipulated ranges, e.g., 3× ULN (upper limit of normal)? |
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