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Updates to the database take place once every hour during normal operation but this can be shortened to 20 min as required during public health emergencies.
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For security reasons, access to the database can take place only indirectly through the DREAM Software: the users (the coordinator, doctors, nurses and operators) do not have the privilege of direct access to the database.
A data check of this database will take place according to pre-defined trial rules (range-, vanddity-, and consistency- checks according to defined SOPs developed during the course of the trial and documented in the trial master file).
A first step consisting of people training and database development will take place prior to the collection of data.
After participant data have been entered in a web based database, computerized randomisation will take place.
Once informed consent has been given, and patient data have been entered in a web based database, computerized randomisation will take place.
Then they have to send the information to the Ministry of Health, where it must be manually entered into a database before analysis can take place.
Data are sent to Dhaka for entry in an MS Access database, where further quality checks take place.
The entries of the database are time stamped and presented to the user together with an option to repeat the analysis, which is advisable if major updates of the genome or structure database have taken place since the previous analysis was performed.
However, for data exchange to take place between federated databases, a mechanism and standardization of format must be agreed.
In practice this implementation creates difficulties in applying queries in the database while violation of the integrity constraints might take place.
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