When choosing an IT solution for collecting data for a research study, quality study, quality registry or long-term research registry, you must use an approved IT solution. Hospitals may have different requirements, so it is advisable to investigate locally which solutions are approved at your hospital.
The solutions described here are all approved for use by Oslo University Hospital (OUS).
Medinsight Classic is an approved solution for use in research projects, quality registries and long term research registries with a broad consent. The solution offers tailor-made IT solutions for collecting structured clinical data. Data is stored securely in a SQL database. Forms and CRFs, logic, process flow and reports are produced at the customer's request.
Viedoc is approved for research projects, but not for quality registries. It is a web-based solution for data collection, which meets the requirements for drug studies (GCP), and is therefore well suited for this type of study. The solution also has a module for obtaining patient-reported data via PC, mobile or tablet. Studies are designed by the Clinical Trials Unit at OUS (CTU), which can also perform data management tasks such as data control, coding, writing data management documentation and more. The close follow-up of projects using Viedoc means that the solution entails a cost for the user. There will be a one-off fee for developing the database, as well as annual licensing costs. Please contact CTU for more information.
TSD (Net-form) is an approved solution, developed and operated by the University of Oslo, for use in research projects. The solution cannot be used for quality registries. The TSD meets the law's strictest requirements for the processing and storage of sensitive research data, and is a web-based form solution for secure data collection. The solution is suitable for less complex research projects, although there are degrees of tailoring here too, for example there are dedicated tools for particularly demanding and heavy (genetic) data sets.
The TSD works with a simple user interface and it is easy for the user to design and edit forms. The solution is free of charge for South-Eastern Norway Regional Health Authority (HSØ) research projects. There is short waiting time for access to the solution.
For more information: TSD support
Ledidi Core ble produksjonssatt til forskningsbruk den 21. mai 2024 i Helse Sør Øst RHF (HSØ).
Ledidi Core er en selvbetjent sky basert IT-løsning for innsamling av strukturerte data (egnet til multisenter studier) og utføring av enklere analyser. Foreløpig er løsningen kun godkjent til forskningsstudier, men det pågår en prosess for å godkjenne løsningen for bruk til kvalitetsregistre. Forsker kan selv designe spørreskjema, importere Excel filer, og legge til prosjektdeltakere i løsningen. Løsningen støtter foreløpig ikke innsamling av data direkte fra pasienter (eks. PROM/PREM skjema). Data skal samles inn pseudonymt. og kodelisten skal lagres i henhold til kravene som foreligger i hvert enkelt helseforetak. Ved Oslo universitetssykehus skal Medinsight kodelisteregister benyttes.
Det er blitt utarbeidet en vurdering av de krav som stilles til bruk av eCRF løsninger i kliniske studier og hvilke områder som dekkes inn i Ledidi (i regi av å være er en regional IKT løsning) per i dag som forsker kan bruke for å gjøre en risikovurdering i forhold til hver enkelt prosjekt/protokoll og den samlede kompleksiteten i studien.
Løsningen er anskaffet som en selvbetjeningsløsning av HSØ RHF.
For mer informasjon om premisser for bruk av Ledidi Core, kostnader ved bruk, tilgang til bestillingsinformasjon og brukerveiledninger, videoer, FAQ etc., så henvises det til Helse Sør-Øst RHF informasjonsside for Ledidi.
eReg editor is an approved solution for use in research projects and quality registries. The solution is approved for use by National medical quality registries and is developed at OUS and managed by the Department of Biobank and Registry Support. The researcher/clinician designs their CRFs (forms) in an application interface. The solution is built on web-based technology, but in order to meet national security requirements (access to, collection of and processing of sensitive data), the solution, in cases where access to sensitive data is needed, will be limited to access within the hospital network.
Contact information/support: eReg Editor support
These solutions are only approved for research projects but are easy to use for the collection of de-identified or anonymous data. The user creates and edits CRFs or questionnaires him-/herself. The solution has good search functionality and good export possibilities for several types of file formats. The software is free to use and can be ordered at Sykehuspartner. The solution is recommended for small and medium-sized projects with low design complexity, where focus in on simplicity and user-friendly functionality. The solution is not web-based and data is stored locally. There is no official user support from the department of Biobank and Registry Support regarding these systems. Contact Sykehuspartner for access to Epidata Manager end Epidata Entry Client.
For more information, see Epidata.
