Appendix: Glossary of Data Integrity Terms

Term	Definition
Audit trails	An audit trail is a process that captures details such as additions, deletions, or alterations of information in a record, either paper or electronic, without obscuring or over-writing the original record.
Data	Data means all original records and certified true copies of original records, including source data and metadata and all subsequent transformations and reports of this data, which are recorded at the time of the GxP activity and allow full and complete reconstruction and evaluation of the GxP activity. Data is to be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio or video files or any other media whereby information related to GxP activities is recorded.
Data integrity	The extent to which all data are complete, consistent, and accurate throughout the data lifecycle (UK Medicines and Healthcare products Regulatory Agency MRHA).
Metadata	Metadata 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. Metadata also permit data to be attributable to an individual.
Original record	Data as the file or format in which it was originally generated, preserving the integrity (accuracy, completeness, content, and meaning) of the record. Examples include original paper records of manual observation and an electronic raw data file from a computerized system.
Raw data	Original records and documentation, retained in the format in which they were originally generated (i.e., paper or electronic) or as a “true copy”. [NOTE: Paper printout of electronic records is not considered raw data.]
True copy	A true copy is a copy of an original recording of data that has been certified to confirm that it is an exact and complete copy that preserves the entire content and meaning of the original record, including, in the case of electronic data, all metadata and the original record format as appropriate.