According to federal regulations (45 CFR 46), by definition, research is ‘a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge’. The ability to meet that aim depends on multiple factors, one of which is the ability to collect ‘good’ data (meaning, the data is accurate, reliable and reproducible).
In order end up with a ‘good’ dataset at the end of a project, study teams must be cognizant of maintaining accurate records/documentation throughout the entire course of the research.
Good Documentation Practices (GDP) is a term used by the pharmaceutical, laboratory and manufacturing industries to describe best practices surrounding the creation and maintenance of documentation (in both paper and electronic format).
While there is not one specific regulation or policy that defines GDP, components of GDP are cited by federal and international agencies, including the Food & Drug Administration (FDA), the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the World Health Organization (WHO), as well as institutional policy.
GDP is essentially good recordkeeping practices to help ensure the quality and integrity of the data collected. This is applicable to all types of research, both biomedical and social/behavioral/educational, and includes records and documentation of study observations, activities and data.
Key attributes of ‘good’ documentation, often referred to as the ALCOAC standard, and include documentation that is:
Expand All AttributableStudy documentation should identify who recorded the data/information; the information should be traceable to a person, date and time (as appropriate).
Study documentation, including signatures, should be easy to read, understandable, and identifiable.
ContemporaneousInformation should be recorded as it happens and the information recorded within study documentation should flow in a correct and appropriate timeframe.
Study documentation should be the original source document. Alternately, an exact/certified copy of the original (as appropriate) should be maintained, with notation referencing the original source.
Study documentation should be correct, free from errors, consistent and a real representation of facts.
Study documentation should be all-inclusive and comprehensive.
Other key attributesAdditional key GDP attributes include: