Data Management
Good data management in clinical trials ensures good data quality and reliable results.
What is Data Management?
The purpose of data management in clinical trials is to develop a database where the data are identical to the collected data as recorded in the source documents (e.g., patient records). The database should be of high quality by minimising errors and missing data in your results. It should reflect the research protocol and meet trial specific quality requirements.
Data Management Services
Data management is a specialised field requiring high levels of expertise, experience, and precision. According to Good Clinical Practice (GCP), individuals responsible for data management in a clinical trial must be qualified and able to document sufficient training. If you are conducting a drug trial or trials on medical devices intended for CE marking, you are required to comply with Norwegian legislation and GCP guidelines. GCP is an international ethical and scientific quality standard for conducting clinical trials.
Section for Data Management
In the South-Eastern Norway Regional Health Authority, data management expertise is centralised in the Section for Data Management, part of the Clinical Trials Unit (CTU) at Oslo University Hospital. The section consists of 12 full-time staff members specialising in data management for clinical trials, primarily within the South-Eastern Norway Regional Health Authority.
The section is a regional research support service offering:
- Set-up of electronic case report forms (eCRFs) in the Viedoc™ data capture system
- Electronic randomisation solutions within eCRFs
- Electronic logistics for medication management
- Electronic collection of patient-reported outcome measures via participants' personal devices (PC, mobile, or tablet)
- Electronic Trial Master File (eTMF)
- Data validation
- Coding of medical terms
- Provision of data during the rial for annual reporting, safety assessments, and other analyses
- Central monitoring
- Delivery of files for analysis and archiving of locked databases
- Data management documentation
In August 2019, the CTU and the Section for Data Management received Data Centre Certification from ECRIN (European Clinical Research Infrastructure Network). This certification demonstrates that the section meets ECRIN’s standards for data management in clinical trials. It confirms that we have a framework adhering to international best practices, have documented this framework, and deliver trials in compliance with international quality requirements.
Advisory Services
When planning a clinical trial, you can contact us via email or the request form with questions related to data management. The Section for Data Management offers free advisory services to all hospitals within the South-Eastern Norway Regional Health Authority.
Data Management Services
Operational data management services are resource-intensive. The section delivers these services at a high quality and very competitive prices for trials conducted within the hospitals in the South-Eastern Norway Regional Health Authority.
Data management services are billed according to the current NorCRIN rates. Please feel free to contact us for updated prices. The cost must be accounted for in the project’s budget. It is worth noting that this expense ensures compliance with laws and regulations, while also enhancing the quality of your trial. Additionally, contracting different services to the CTU provides a significant added value, as the department will ensure a close collaboration between data management, monitoring, statistics, health economics, and project coordination.
The services you require or wish to include in your trial will be agreed upon in collaboration with us.
Data Management in Practice
The data manager designs a precise, self-explanatory, and user-friendly eCRF in Viedoc™ that reflects the trial protocol.
In trials with patient-reported outcome measures, an electronic solution (ViedocMe™) is utilised.
For randomised trials, an integrated randomisation solution is developed in collaboration with a CTU statistician.
The primary focus during eCRF development is data quality. Automatic data checks are programmed to prevent illogical, invalid, or incorrect data. During the trial implementation phase, manual data checks and central monitoring are conducted to identify additional errors and inconsistencies in adherence to the trial protocol across trial sites and/or countries.
Before the eCRF is implemented, necessary testing, including User Acceptance Testing (UAT), is conducted and documented in collaboration with the trial team, the data manager, and the multidisciplinary team at the CTU.
Essential documentation such as the data management plan, data quality plan, User Acceptance Testing (UAT), and data management report outlines the data management process from planning to study completion.
Before the database is locked, the data manager ensures, in collaboration with the trial team and the CTU multidisciplinary team, that the data in the eCRF are as complete and accurate as possible.
Viedoc
Viedoc™ is a web-based solution for data collection that meets the regulatory and functional requirements of clinical drug trials. The system also includes a module for collecting patient-reported data via PC, mobile, or tablet (ViedocMe™). A licence fee applies for Viedoc™.
Viedoc™ is a complex system with many features and functionalities. Therefore, the data manager also dedicates time to training trial teams throughout the process. Some of this is done during meetings while the database is being built, and through testing by key trial personnel. For multi-centre trials, a start-up meeting is often held where the data manager demonstrates how to use Viedoc™, how to enter data into the eCRF, and how to communicate within Viedoc™ once the trial is underway. Familiarity with the database before the trial begins is beneficial.
If applicable, ViedocMe™ is used for collecting patient-reported data. In ViedocMe™, trial participants can complete electronic questionnaires on their own devices (smartphone, PC, or tablet) and receive reminders via SMS or email with links to the forms they need to complete.
Our Staff
An overview of our staff can be found here (in Norwegian).