Quality management

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In order to guarantee homogeneity between each center, standardized procedures are established:
  1. Data are collected by each local clinical research assistants (CRA) according to an common thesaurus.
  2. Modifications of the database are recorded with the effective date.
  3. When possible, the collected data is submitted to coherence tests with other variables.
  4. Missing data is distinguishable thanks to a coding system that tags either validated missing data (without solution to find the information), missing data waiting for validation, and missing data without any precision (which can corresponds to an omission).

We also perform an annual cross-audit that evaluates the quality of the collected data:
  1. A collection audit aims at ascertaining the quality of 30 randomly-selected transplantations per center. Twenty-five items are randomly controlled among baseline and follow-up required variables and five items (consent form, initial disease, cold ischemia time, immunosuppressive regiment and HLA typing of recipient and donor) are systematically monitored.
  2. A completeness audit is also carried out on 10 randomly-selected transplantations per center. Three items among follow-up required variables are randomly controlled whereas essential data concerning proteinuria and anti-donor specific antibodies immunization are systematically monitored.

Moreover, a multivariate correlation model performs automatic controls, send to CRA, to confirm or to correct information. Read more.
Data of a center newly entered in the network cannot be used for scientific works until the first audit is performed.