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DMSys uses a batch structure for data entry and verification (second data entry). A batch might include all the CRFs received from one site or all CRFs completed or received over a period of time. When you start entering a new batch of data, DMSys creates a new data file for each Form included in the batch. This process is repeated when you perform verification of the batch, the only difference between data entry and verification being in the naming of the data files.

This system has significant advantages in terms of the integrity of your data. Once a batch of data has been entered and verified, the data files can be locked.

All functions and studies in DMSys are protected from unauthorized use. A user must be given the privilege to access each individual menu item and clinical study so that, for example, a user who is not authorized to enter data corrections is unable to do so. Likewise, a user who is given access to a subset of studies cannot access a study for which they do not have permission.

Each user must have a user name and password; both have to be recognized by the system before the user can log-in. Users are required to change their password at regular intervals. A record is kept of all successful log-ins and log-outs and unsuccessful attempts to log-in.





 

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