Mail Carrier

In clinical trials that solely or partially rely on paper forms and pure paper-based data collection systems, participating sites use a mail carrier to send batches of hard copies of completed forms to the coordinating center. With this approach to data, forms and computer programs are necessary to keep track of received batches of completed forms.

The mail carrier is also used as a means of communications to transfer special electronic files saved on diskettes, CDs, or tapes among resource centers, participating sites, or the coordinating center. Such electronic files may contain collected clinical data or system update batches. For example, in the VA Cooperative Studies Program (CSP) #399 trial (Singh et al. [6]), transtelephonic monitoring (TTM) data were extracted from the Transtele-phonic Center database at the Washington, DC VA hospital, saved on diskettes, and sent monthly to the Hines VA Cooperative Studies Program Coordinating Center (CSPCC). In the VA CSP #7 trial, Anderson et al. [7] reported a system in which tape cartridges were used to send the entire database monthly from the coordinating center at the Seattle VA to the Hines VA CSPCC, the data center for the trial. In both cases, FedEx was used as the mail carrier. The files may be system updates, as in the distributed data collection and management system of the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) (Abdellatif et al. [8]), or files containing verbatim adverse events to a centralized location, such as a pharmacy coordinating center (PCC) for coding to a standardized coding dictionary [9]. This approach to communications, however, does not provide instant access to the information.

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