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The voluntary survey ran between July and October 2014 and could be completed anonymously on a password secured website.
This is a web-based password secured and encrypted data management system designed specifically for clinical trials in this area.
The randomisation process will be performed by a web-based password secured and encrypted data management system designed specifically for the randomisation of participants into clinical trials.
PCT levels are communicated by the password secured website to the treating physician together with a treatment recommendation for antibiotics based on the PCT algorithm exclusively for patients randomized to the PCT intervention arm.
Despite the data management protocol and even though the database was kept in a secure environment and all data traffic was password secured, this was not enough to prevent resistance.
Data collectors and other study staff will ensure the confidentiality of logbooks and other data storage devices (e.g. computers) by ensuring that logbooks are not taken out of the hospital premises, keeping them in locked lockers, password secured databases and secure removal of computer data/shredding of any study logbooks at completion of central database cleaning.
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She said that each site would be password-secured so that the only people with access would be those given passwords by manufacturers.
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