Pragmatic Trial resources


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Data Management Guidance Box

In order to assess the applicability of a data source or system to be used in a pragmatic trial, it needs to be carefully evaluated and monitored. This page provides a list of important questions that need to be addressed before choosing a specific data source/system. Based on the answers to these questions, trial teams can make an informed decision on the applicability of the data source and/or implement additional steps / actions to address potential flaws.

We have gone through different pragmatic trials in which a diverse set of data sources were used. This page provides information on how the trial teams tackled the revealed flaws and how the data sources used in these trials addressed these questions.

1. Completeness of Data

2. Implementation of additional data collection

3. Integration of data

4. Data standards

5. Timing of data transfer (from EHR to Study-database)

6. Data quality

7. Data audit trail process // Data provenance

8. Retention and archiving

9. De-identification

Overview of Initiatives


Download the Data Management Guidance Box for an overview of challenges and challenge-specific questions.