Application for OPEN

There are no deadlines for submitting project applications to OPEN. Applications are processed continuously, and you can apply at any stage of your project, even during the planning stage. It's not required to have all relevant approvals when applying; these can be submitted at a later time.

All employees in the Region of Southern Denmark or at the Faculty of Health Sciences at the University of Southern Denmark (SDU) are eligible to apply for project admission to OPEN. OPEN may also have agreements with other institutions about project admission. The conditions for admission may vary based on your institutional affiliation and which of OPEN's facilities that you plan to use.

Once you submit your application, OPEN will invite you to a one-hour admission meeting. During this meeting, we will discuss how OPEN best can support your research project. To ensure a productive discussion, OPEN's staff will review your project beforehand. It is therefore important that you send your project description, budget, and any other relevant documents before the meeting.

Projects admitted to OPEN may include activities such as consulting, database development, data collection, data storage, data processing, data analysis, monitoring, and other tasks related to quality control or research development within the hospitals of the Region of Southern Denmark. Many projects are also accepted at the Faculty of Health Sciences at the University of Southern Denmark. Additionally, OPEN may have agreements with other institutions regarding project admission.

There are no specific requirements regarding the size or scope of the projects. However, in general, OPEN only accepts research projects that are comparable to an undergraduate research project, as well as those where OPEN's support is considered beneficial for successfully carrying out the project.

Advantages of using OPEN

OPEN securely stores your data on our established databases and IT platforms
REDCap facilitates randomisation, online questionnaires, data collection, and project management for non-commercial projects
OPEN provides a dedicated analysis platform designed to meet the specific needs of your project
OPEN offers comprehensive support for register-based research projects
OPEN is equipped to assist with qualitative research projects
OPEN Biobank ensures the proper management and tracking of your biological samples
OPEN can help you identify the most appropriate tools for your project
OPEN staff are available to offer expert guidance on registry linkage, statistical strategies, legal reviews, and other related matters
OPEN provides access to data from Statistics Denmark and the Danish Health Data Authority
OPEN boost the visibility of your project through its website, network, and activities, potentially leading to collaborations with other researchers interested in utilising your cohort

As the project manager, you retain full control over your project’s data and biological samples stored in OPEN, even after project admission. Should other researchers express interest in accessing your data or samples, they may contact OPEN at open@rsyd.dk, and we will facilitate communication between you and the interested parties.

Each project admitted to OPEN is allocated 30 hours of assistance. However, different terms may apply to universities and hospitals outside the Region of Southern Denmark. The 30-hour limit does not apply to services provided by the OPEN GCP unit. For more information on how these hours can be allocated across OPEN's various facilities, please refer to OPEN's price list.

OPEN also offers more comprehensive support for many of its facilities and services. Additional funding for extended assistance and potential co-authorship (in accordance with Vancouver criteria) can be arranged through consultation with OPEN. Departments outside the University of Southern Denmark and hospitals in other regions may access OPEN’s facilities for a project-based fee.

OPEN Project Coordination

All projects registered with OPEN go through OPEN’s Project Coordination. Key services include:

Registration and ongoing support
Establishing the project as an OPEN project
Creation of a licence agreement
Project promotion on OPEN’s website
Reminder prior to the expiration of data processing and storage permissions

OPEN IT & Data Management

REDCap

REDCap provides a secure, customisable platform for managing online surveys and databases in health research. Services related to REDCap include:

Free access to REDCap and OPEN's REDCap courses
Account setup and advanced support
Guidance on form structure, validation rules, and codebooks
Secure data storage in compliance with applicable laws and regulations
Ongoing maintenance and updating of REDCap
Data transfer to the National Archives after data processing and storage approval expires

OPEN Analyse

OPEN Analyse is a safe analysis platform that helps researchers process data while adhering to data protection requirements. It supports clinical, qualitative, and registry research, and includes software like STATA, NVivo, and R. Services provided by OPEN Analyse include:

Account setup
Introduction and guidance on usage
Assistance with data transfer, pseudonymisation, and encryption
Full access to both STATA and R
Data transfer to the National Archives when data processing and storage approval expire
Secure data storage in compliance with applicable laws and regulations
Ongoing system maintenance and development

OPEN Storage

OPEN Storage offers a secure and reliable platform for storing and analysing research data, adhering to data protection standards. The platform can handle larger research files, such as images, audio recordings, and sensor data. Key services include:

Account setup and introduction
Assistance with data transfer, pseudonymisation, and encryption
Secure data storage in compliance with applicable laws and regulation
Ongoing system maintenance and development

OPEN Registry

OPEN Registry provides consultation and guidance on the use of Danish registries and offers assistance with data management and analysis for research projects. Key services include:

Assistance with starting registry studies, including integration with clinical or survey data
Support with planning and executing register-based research projects
Help accessing data from the Danish Health Data Authority, Statistics Denmark, or OPEN’s Register Database
Guidance in specifying data extractions for research purposes

OPEN Registry can also become more directly involved in register-based research projects, taking part in scientific collaborations, data management, and conducting data analysis.

OPEN Register Database

OPEN Registry manages a register database at Statistics Denmark, which holds a large subset of data from national registers. Key services include:

Review of project settings and extraction specifications
Submission of materials to Statistics Denmark
Generating cohorts based on project specifications
Providing a data security course before researchers gain access to their project
Access to the OPEN Register Database is financed by the project, according to its specific data requirements.

OPEN Statistics

OPEN Statistics supports health researchers by providing expert statistical advice and assistance with research projects. Key services include:

Consultation on study design and statistical methodology
Advice on interpreting results

For more in-depth involvement, OPEN Statistics can also offer support in the planning and execution of research projects, as well as assist with conducting and interpreting specific statistical analyses.

OPEN Qualitative

OPEN Qualitative offers guidance and support for qualitative research projects, including surveys with open-ended questions and literature reviews focusing on non-numerical data. OPEN Qualitative also gives access to NVivo, which is is a software used for transcription, structuring, coding and analysis of qualitative data. Key services include:

Access to OPEN's NVivo and qualitative methods courses
Consultation on data collection, analysis, visualisation, and dissemination of qualitative studies
Guidance on ensuring project quality and maintaining clear research records

For more in-depth involvement, OPEN Qualitative can offer extensive advisory support, including assistance with coding and analysis.

OPEN Biobank

OPEN Biobank provides support for the secure collection, storage, and management of biological samples for health research. It ensures standardised handling, complies with regulations, and enables collaboration through a searchable database that integrates with the Danish Biobank Register.

Expenses related to handling, preparation and registration of sample materials are settled directly with the laboratory responsible for the samples.

OPEN must be acknowledged in the acknowledgements section of all publications resulting from the project, except in cases where an OPEN employee is a co-author.

The acknowledgement should specify which OPEN facilities were used for the project and must reference OPEN as follows: “OPEN, Open Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark.” Licence holders and co-signers from the Region of Southern Denmark are also entitled to use OPEN as an affiliation in publications resulting from the project. This affiliation should be listed as: “OPEN, Open Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark.”

If permitted by the journal, please include a hyperlink to OPEN: https://www.sdu.dk/da/forskning/open. The project must notify OPEN of any publications by emailing open@rsyd.dk so they can be included in the project descriptions on OPEN’s website. When using REDCap, please adhere to REDCap’s citation and acknowledgement guidelines.

To proceed, please complete OPEN’s online application form (linked at the top) and attach the required documents. If your project involves biological samples, you may contact the relevant laboratory department directly to arrange further details.

If your project is admitted to OPEN, the project manager must either upload the relevant permissions in the application form or email them to open@rsyd.dk once obtained. The required permissions may vary depending on the nature of the project.