26.05.2014

Clinical Data Management in OCQMS

Clinical Data Management is critical for establishing high standards over the entire process from data generation to data extraction and statistical analysis.

Data Entry

Data is entered at the contributing hospitals by study nurses and medical docters. The data entry forms have a clear structure that makes them easy to use for all users.

Data Validation

Data validation happens during data entry with validation rules on the online forms. Addition verification steps for the data can take place at the hospital level by requiring a user with a special role (signer) to sign and close a data entry (visit).

Data Cleaning / Discrepancy Management

For data that does not pass post-signing validation rules a request for clarification can be issued by the study monitor. The responsible user at the hospital level will be notified about this request. The whole communication on the request for clarification is tracked in the database.

Data Extraction / Research

Data of finalized visits are ready for download as CSV files. All data of the registry is mirrored to a separate export format (research database). During the transfer process data transformations take place to bring the data into a tabular structure and to anonymize personal subject data. To ensure full reproducability of data queries we create periodic snapshots of the research database. A snapshot is a complete immutable set of CSV files with a consistent naming convention (YYYY-MM-DD: e.g. 2014-01-01).