Glossary
- Announcement of scientific use
- Announcements of scientific use are subject to restrictions regarding applicants and the study population. The main applicant, co-applicants, and data recipients listed on an announcement of scientific use must be employees of a study center participating in the NAKO Health Study. Furthermore, the study population for which data use may be requested is limited to the applicant’s own study center. Announcement of scientific use are not reviewed by the Use and Access Committee (UAC). However, the Executive Board has the right to suspend announcements of scientific use indefinitely, e.g., if a majority of its members believes that the topic of the application should first be analyzed and published using the complete dataset of all participants. Announcements of scientific use do not require a contracts of use. The provisions governing announcements of scientific use are based on the NAKO e.V. use and access policy.
- Applicants
- A list of researchers who wish to use data and/or biological samples in a collaborative project.
- Co-applicants
- Another person to be included in the usage request. This person may also assist in preparing the usage request and will be included in the contract of use.
- Contract of use
- This agreement governs the rights and obligations of the NAKO e.V. and the applicants. It is concluded between the NAKO e.V. and the participating institutions in each case.
- Contractual partner
- Contracts of use are entered into between the contractual partners involved.
- Data dictionary
- A directory containing metadata. It includes a hierarchical list of all study variables, along with question texts, response categories, data types, and other information.
- Data quality workgroup
- is responsible for checking the content of the Requests for quality assurance.
- Data recipient
- In some cases, not all applicants listed on a usage request are to receive data; therefore, the data recipients are explicitly listed in the request.
- Independent trust office
- Before data can be transferred, the independent trust office verifies whether consent has been given and whether any revocations or objections to use have been filed. Furthermore, the trust office is contacted during the process of assigning biological samples and in the event of incidental findings.
- Integration center
- It serves as a central data management system by consolidating all study data (except for biosample information) and, subject to a contract of use with the data transfer office, making the data available to data recipients.
- Issue key
- Submitted usage requests are assigned a unique identifier in the format NAKO-99999. Please be sure to include this identifier in all communications.
- Main applicant
- An usage request is initially submitted by one person. That person usually handles the correspondence as well.
- Population
- see Study population
- Pseudonymized data
- data that has been handed over, which, in justified cases, allows for the return of data.
- Requests for quality assurance (short QA request)
- Applications for projects aimed at ensuring the internal quality assurance of NAKO study data are submitted to the data quality workgroup. If approved, a contract for data processing on behalf of NAKO and the subsequent return of the quality-assured data are generally required.
- Requests for scientific use (short UA request)
- Requests to use study data and biosamples for scientific analysis are submitted to the Use and Access Committee (UAC). Upon approval by the Executive Board, contracts of use are concluded between the participating institutions. These contracts are based on the NAKO e.V. use and access policy.
- Selection expression
- A composite logical selection criterion used to describe a subpopulation.
- Study center
- Locations where the study is being conducted.
- Study population
- The set of people who participated in the study.
- Study variable
- Defines a value collected from study participants. This definition includes a unique identifier, a descriptive text, values, and, if applicable, references to standard procedures for data collection. Study variables are organized hierarchically within the data directory.
- Subpopulation
- Using selection criteria, any number of subpopulations can be defined within the study population, which can then be analyzed separately or compared with one another. Data and biological samples are often released only for subpopulations that have been specified in advance.
- Transfer office
- is responsible for making the study data and biosamples from the NAKO Health Study available for scientific use. In the future, researchers outside the study centers will also be able to submit requests for access in accordance with use and access policy.
- Usage request
- Formal request for the designated use of study data and biosamples from the NAKO Health Study.
- Use and Access Committee (UAC)
- This committee assists the association in processing applications for the use of data and biosamples for scientific analysis in accordance with the association’s use and access policy. It reviews the application based on a wide range of criteria and submits a written recommendation to the association’s board of directors.
- Use and access policy
- see information on the Use and Access procedure
- Variable set
- For data protection purposes, individual data releases may only include study variables for which a justified rationale has been provided in the context of a data access request. Applicants use the data catalog to compile the relevant variables. These lists can be managed separately as designated variable sets and are referenced in the usage request.