MII Implementation Guide Medizinisches Forschungsvorhaben - Downloaded Version 2027.0.0-ballot See the Directory of published versions

Guidance

This section collects the domain guidance for implementing and using the Medizinisches Forschungsvorhaben module.

General Implementation Guidance

• Datasets and Descriptions — the module's data elements, described as logical models. (This entry shares its target with Artifacts → Logical Models; neither Artifacts-Summary anchor is usable as a link target — see docs/page-structure.md in this repository.)
• UML Diagrams — visual representation of the data models and their relationships.

Audience-Specific Guidance

• Guidance for Implementers — technical guidance for DIC implementers.

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For the KDS-wide conformance requirements see the Conformance rules of the Meta module; for the technical artifacts see Profiles.

Description of Scenarios for the Application of the Modules

At the outset, the team of the Medical Research Project module developed a large number of possible scenarios that would influence the design and scope of the module. In order to arrive at a first consensus-able version, the following focus areas were identified, on which the present model concentrates:

1. Support of the concept of the research study in the sense of a structured project with characteristics for identifying and managing a research project and for representing the basic characterizing features (study registry)

2. Support of the concept of the subject in the sense of an identifiable subject and representation of the basic characterizing features for tracking and traceability

3. Support of the concept of eligibility in the sense of the possibility of defining structured inclusion and exclusion criteria, on the basis of which it can be decided, at least partially automatically, whether an individual with their intrinsic characteristics belongs to the target population or not.