What is it? Why is it important?

Metadata describes and gives information about data. Also referred to as “data about data”.

Metadata provides basic information on data. Its aim is to help organise, find and understand data (e.g. images, videos, or spreadsheets).

Metadata can be evaluated and displayed by search engines during searches.

Metadata can explain the origin, the purpose, the time, the geographic location, the author, the access, and the terms of use regarding some data.

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Examples of metadata information

  • Descriptive information:

Intellectual content or origin. Allows the data to be searched and retrieved (e.g. title, abstract, author, keywords)

  • Structural information:

Internal structure, technical description (e.g. page, sections, chapter numbering, indexes, table of content, variable names, dataset location)

  • Administrative information:

Long-term and short-term management and processing (e.g. technical data, access control, user requirements, archiving)

  • Explanatory information:

Provides context to statistical data (e.g. the methodology used for data collection and aggregation or, methods used for data quality check)

  • Statistical information:

Processes used to collect, process, and describe statistical data

  • Keywords:

Provides the search engine with additional information

What do I need to do?

Make yourself familiar with:

  • Data formats including its applicable metadata (e.g. definition of codes and classification schemes)
  • The use of standardised- / international data formats (e.g. CDISC format)
  • Metadata requested by authorities (e.g. SNSF, FDA, EMA)

Data sharing and the comparability of study results are increasingly facilitated through the use of standardised formats, including information provided through metadata.

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Examples of study data and their metadata

 

  • Gender: female = 1; male = 2, unknown = 99
  • Primary study endpoint reached: yes = 1, no = 0
  • Missing values: D = participant dropped out of the study, L = participant lost to follow-up
  • BMI: algorithm = weight (kg) / height (m2)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

CDISC – see in particular

  • Define-xlm – It transmits metadata that describes any tabular dataset structure

Datacite – see in particular

  • Datacite Metadata Schema – List of properties for consistent identification of a resource for a citation
Abbreviations
  • CDISC – Clinical Data Interchange Standard Consortium
  • CTU – Clinical Trials Unit
  • EMA – European Medicines Agency
  • FDA – Food and Drug Administration
  • SNSF – Swiss National Science Foundation
Basic ↦ Data Handling ↦ Study Database ↦ Metadata
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Data Handling ↦ Study Database ↦ Metadata

Please note: the Easy-GCS tool is currently under construction.