The GLP regulations are a Quality System intended to assure the quality and integrity of the data; this includes data derived from Animal Rule studies. Sponsors may include GLP compliance (or components thereof) as contractual or funding
The ALCOA principles of Good Documentation Practices (GDP) provide the foundation for assuring data quality, where:
A= Attributable (the individual who collected the data or made the original observation)
L = Legible (readable, code available)
C = Contemporaneous (information recorded/captured/documented in real time)
O = Original (or exact copy thereof)
A = Accurate (truthful)
Data integrity can be evaluated through the lens of documentation (study records) being complete, consistent, enduring, and readily available.
The World Health Organization’s Handbook on Quality Practices in Basic Biomedical Research states the following:
“Making a full record of all information
is essential not only to permit appropriate scientific interpretation of the results but also to enable complete reconstruction of the study, should this be necessary. Documentation is the only way of demonstrating what actually went on at the
time of the experiment.
Without documentation the process is meaningless; essentially there has been no study.”