Metadata

UK: MHRA Guidance on GxP Data Integrity – Metadata are data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data e.g. audit trails. Metadata also permit data to be attributable to an individual (or if automatically generated, to the original data source) (as per Section 6.3 of MHRA – Guidance on GxP data integrity, March 2018)

Metadata form an integral part of the original record. Without the context provided by metadata the data has no meaning.

Example (i) 3.5 = metadata, giving context and meaning, (italic text) are: sodium chloride batch 1234, 3.5mg. J Smith 01/Jul/14

Example (ii) 3.5 = metadata, giving context and meaning, (italic text) are: Trial subject A123, sample ref X789 taken 30/06/14 at 1456hrs. 3.5mg. Analyst: J Smith 01/Jul/14

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