What is Data Management and Who Can Assist You?
Data management demands high competence, experience, and accuracy. Good Clinical Practice (GCP) requires that those who perform data management in a clinical study are qualified and can document sufficient training in data management. In Helse Sør-Øst (South-Eastern Norway Regional Health Authority), this competence is gathered in the Section for Data Management, which is a part of the Clinical Trials Unit (CTU) at Oslo University Hospital. The section is a regional research support service and can be used by researchers in the Helse Sør-Øst region. The section offers, among others, the following services:
- Set-up of the database (ViedocTM) and electronic clinical report forms (eCRF)
- Set-up of electronic randomization in the eCRF
- Logistics around study medication management
- Coding of medical terms
- Electronic collection of patient reported outcomes via the study participant’s own electronic device (PC, mobile phone, or tablet)
- Data validation
- Reporting of data throughout study conduct for use in yearly reporting, safety assessments, or other analyses
- Central monitoring
- Data cleaning and locking of the database
- Data management documentation
The Section for Data Management collaborates with you to find the right services for your study.
Data management costs must be taken into account in project budgeting. Data management services are billed in accordance with current NorCRIN-prices; please contact the Section for Data management for updated prices.
During the study planning phase, you are welcome to contact us with any questions regarding data management; the Section for Data Management offers free consultations to all hospitals and health trusts in the south-east health region of Norway.