Data management involves the collection, handling, data cleaning, transfer, and traceability of the clinical data. Data management is crucial for ensuring the quality of the clinical study data and providing traceability that shows the data have been managed according to regulatory guidelines, and the conclusions drawn from the clinical study are reliable and trustworthy.
Ensuring data quality
There are several user-friendly, 21 CFR Part 11 compliant electronic data capture (EDC) systems that can be used to build your electronic case report form (eCRF), depending on your budget and requirements. We have experience with a variety of EDC systems, as well as capturing electronic patient-reported outcomes (ePRO), which utilize questionnaires that patients fill out directly on their smart phones.
Data management services include:
• Development of the database design and data management procedures, including the Data Management Plan (DMP)/Data Validation Plan (DVP).
• Planning, setup and validation of the eCRF and/or ePRO form, including logical data checks.
• Investigator and site eCRF/ePRO training, as well as data entry instructions.
• Regular data monitoring, including data checks, data queries, and reports to aid CRAs/monitors and data monitoring committees.
• Database closure activities, including documentation of clean file, database lock and data export.
