Source data verification

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EACTS Congenital Database Source Data Verification Protocol

The data verification procedure at the site is planned in steps as following:

100% of patients data of 2003 is supplied to the Database

The DatabaseCoordinator sends to the site the documents, that consist of:

  • List of patients ID of 2003
  • Form claiming the completeness of patients list and the mortality. This form needs to be undersigned by a hospital authority (e.g. Medical Director).

the form of data verification at the site containing list of items that will be verified.

Person locally responsible for the verification indicates the source of information at the site, different to the local copy of the database and related to the database (patients' files, hospital computerized system etc.).

The DatabaseCoordinator visits the site and checks on the reliability of the data undergoing verification according to the form provided.

After verification is completed the person locally responsible undersigns all forms.

The database coordinator forms claiming the completeness of the patients list (2003) and the mortality.

The hospital mortality will be defined as "at 30 days" or within the same hospitalization.

Every Database member who went through the verification procedure will be included into the list of co-authors of any publication referred.

Bohdan Maruszewski MD PhD, EACTS Congenital database director