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(d) Are abnormal results tracked and does the laboratory monitor for key events? |
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(e) Can different flagging criteria be applied to specific patient visits or to different therapeutic areas? |
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(a) Check the electronic transfer of data, agree on the coding to be used, and ensure procedures are in place regarding cleaning header demography and the electronic transfer of results. |
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(b) Expect flexibility so that the laboratory conforms (at a price) to the wishes of the sponsor. |
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(c) Obtain guarantees that the format is not changed without the sponsor being informed and agreeing to the change. |
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It is important to involve the central laboratory early at pretrial investigator meetings so that any problems can be resolved. The meeting also provides an opportunity to build confidence between the Investigators and laboratory. The real bottom line is to avoid any surprises, either way. A laboratory protocol, which specifies the logistics of the trial, should be agreed on and should include contract costs, terms and conditions, responsibilities, the procedures to be followed by the laboratory (e.g., sample handling), and instructions to investigator on what to do and what to expect. It is important that the laboratory protocol should clearly define: the expectations from different parties, the timelines for the different activities, and the responsibilities of the different parties. Ensure that any specialised test is fully validated and documented and that the laboratory has the proven expertise to perform the tests. |
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Investigator buy-in is another major factor that should not be dismissed lightly. Historically, investigators have shown a reluctance to work with a central laboratory but attitudes are changing. On occasions it may be necessary to take investigators to the central laboratory to show them how highly proficient and sophisticated these facilities are in order to address their queries and allay their concerns. |
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Two areas of potential conflict are (a) divergence from agreed timeline (i.e., the time from the collection of samples to the delivery of final report) and (b) total cost and budget over-runs. There should be no surprises and all costs should be agreed up-front and stipulated in the contract. It is, however, prudent to agree up-front how much extra the laboratory can spend in an emergency to ensure sample integrity if the sponsor cannot be contacted. |
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Finally, it is important that the investigator/study nurse's life is made as easy as possible by: |
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