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(b) Training must be given in the sample-preparation procedures. |
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(c) The central laboratory must provide all syringes, tubes, and needles to take blood samples in a trial specific phlebotomy kit. |
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(d) Accurate recording of patient and visit identity on both tubes labels and accompanying sample documents is essential. |
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(a) Training of on-site personnel in using the kit and packaging must be given. |
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(b) It must be ensured that kits and packing supplies arrive on time at each center and are resupplied throughout the trial. |
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(c) It must be ensured that the investigator uses the supplied kits and does not revert to hospital supplies. |
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(d) It must be ensured that all appropriate documentation is provided (e.g., air way bills, customs declaration, any biohazard documentation, and International Air Transport Association regulations are completed and signed by the correct authority). |
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(e) Any dry-ice packaging must be more than adequate for the expected transit time. |
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(f) Where possible, preprinted documentation must be provided and simplified courier contact arrangements made in order to minimize investigator inconvenience. |
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(a) Transport time from different locations must be agreed upon with the courier and guarantees of alternative routing in the event of problems must be established and agreed upon. |
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(b) Latest collection times for each center must be agreed upon and it must be ensured that the investigator is aware of the time. |
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(c) Time delays are common in airport security and for samples being stored in dry ice, there is the additional requirement of topping them up. Delays in airport security are usually due to incomplete documentation. All questions must be answered in full and no abbreviations should be used in the responses. |
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(d) Investigators must be provided with clear instructions on how the samples should be stored in the event of the courier not collecting or the collection time being missed. |
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(e) Tracking of samples in transit must be implemented to avoid any sample loss. |
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(f) An effective working relationship with one or more couriers must be established with an understanding that additional costs may be incurred in an emergency to guarantee sample delivery. |
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