The purpose of data management in clinical studies is to deliver a database with data identical to the source data (for example, the patient journal). The data in the database should be of good quality, with the number of errors and inconsistent and missing data as low as possible. The database should mirror the study protocol, as well as satisfy any study specific quality requirements.
ViedocTM is a web-based solution for the collection of data that satisfies the regulatory and functional requirements of pharmaceutical studies. It is a complex system with good functionality that can be used to handle a wide range of study configurations.
The ViedocMeTM module in Viedoc can be used for the collection of patient reported outcomes. Using ViedocMeTM, study participants can fill out electronic questionnaires using their own internet connected electronic devices (smartphone, PC, or tablet), as well as receive reminders via SMS or email, with links to the forms to be completed.
There is a license fee associated with the use of ViedocTM. Please contact the Section for Data management for more information.
The Section for Data Management consists of 10 professionals who currently work full-time with data management in approximately 60 clinical studies conducted at several hospitals throughout Helse Sør-Øst.
In August 2019, the CTU and Section for Data Management were awarded ECRIN (European Clinical Research Infrastructure Network) Data Centre Certification. This certification indicates that the data management unit meets ECRIN’s rigorous requirements for data management in clinical studies, that we have a documented framework that meets international “best practice” standards, and delivers studies according to international quality requirements.
An overview of our employees can be found here.
