Static Record:
A static record format, such as a paper or electronic record, is one that is fixed and allows little or no interaction between the user and the record content.
Static record is used to indicate a fixed-data record such as a paper record or an electronic image.
Static data is data that does not change after being recorded. It is a fixed data set.
For example, once printed or converted to static electronic format chromatography records lose the capability of being reprocessed or enabling more detailed viewing of baselines
Dynamic Record:
Records in dynamic format, such as electronic records, allow an interactive relationship between the user and the record content.
For example, electronic records in database formats allow the user to track, trend and query data; chromatography records maintained as electronic records allow the user or reviewer (with appropriate access permissions) to reprocess the data and expand the baseline to view the integration more clearly.
Where it is not practical or feasibly possible to retain the original copy of source data, (e.g. MRI scans, where the source machine is not under the study sponsor’s control and the operator can only provide summary statistics) the risks and mitigation should be documented.
Dynamic means that the record format allows interaction between the user and the record content
Experts contrast static data with dynamic data, where dynamic data may change after it is recorded, and has to be continually updated.
Source: MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018
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