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15th May 2015, 04:47 PM
#1
ECG tracings
May I ask for your advice/comments please? The sponsor provided us (investigator site) a ECG machine of which ECG data is transferred electronically to the assigned company. At the same time, the machine prints the tracings to site for investigator to review.
- Do you consider if the transmissions are considered as the original source or the thermal paper tracings are.
- Because thermal paper is known to fade away over time, the sponsor requested site to make certified copies of ECG tracings. Could you advise if this is a standard procedure for ECG tracings?
Your advice would be very helpful. Thank you very much.
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