1. Overview
Section content first added by: None added yet
Lifecycles
Section content first added by: Kevin Lee
Metadata should be created before datasets and analysis. Then, the datasets will be created and analyses will be done according to metadata. The well-thought, planned process will yield more complete metadata, but in most of cases, metadata will be modified during the process and will be completed almost at the same time, more accuratley just before all the analyses and datasets are finished.
2. Definition of Metadata
Section content first added by: Chris Decker
At the PhUSE annual conference, an engaging discussion was held with the initial goal of defining the the definition of metadata. At the end of this discussion the group came up with the following definition.
Metadata is a collection of information that
puts data into context
Ot
Other comments were made to help clarify the definition.
- Metadata can be
defined as either metadata or data depending on its use
- Need to work at defining what context means and defining categories of context
- Is a collection of information structured or not structured. The discussion led to collection being structured but the content could be unstructured.
Additionally, the purpose of collecting metadata must be driven by the needs of the business. (Examples to be added).
Do you agree?
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3. Defining Context
Section content first added by: Chris Decker
Within the definition of metadata, the word context was used. Now we must define the different aspects of context that will help better define concrete needs of metadata.
Aspects of Context:
- Medical - the medical meaning of the information
- Technical - how we physical collect, store, maintain, and communicate the metadata
- Structural - What is the structure of metadata model that can support hierarchy and diverse relationships
- Functional - What is the metadata in relation to (e.g. finance, operations, biometrics)
Applications of Context:
- Development of the protocol/SAP
- Collection of clinical data
- Specifications for SDTM/ADaM data
- Metrics to support operational aspects of a study
- Reporting requirements
- Submission
- Reuse of clinical information for future study design or ad-hoc analysis
What else?