The GDPs are an internationally accepted practice by which research and manufacturing data are documented and preserved. While some details of the GDPs are codified (e.g., GLP study conduct requirements), there is no single law that describes the standards that the current research community expects as part of sound research practices.
These practices are considered the minimal practices that ensure that data resulting from your research (or manufacturing) is fit for use and will not be misconstrued or misused. These practices are designed to ensure that your research is reconstructable. These practices also support your intellectual property rights.
What is data?
Data can be described as worksheets, notebooks, records, memoranda, notes, maps, photographs, electronic files, or exact copies thereof that are the result of original observations and activities of a study that are necessary for the reconstruction and evaluation of that activity.
What is considered good data documentation?
General good practices are often described using the acronym ALCOA:
Attributable
- Signed – Who contributed the data?
- Dated – When was the data collected and recorded?
- Identified – What does the signature signify (recorded by, examined by, verified by, approved by)?
- Changes in data attributable by signature, date, and reason for the change without obscuring the original
Legible
- Understandable
- If it can’t be read by someone else, it is not legible
- Adequate space is provided – consider handwriting, size, ‘scrunched’, distinguishable
- Located appropriately – avoid data in the margins/borders, on the back, etc.
- Use permanent ink
- Calculations and transformations are understandable
Contemporaneous
- Understandable
- If it can’t be read by someone else, it is not legible
- Adequate space is provided – consider handwriting, size, ‘scrunched’, distinguishable
- Located appropriately – avoid data in the margins/borders, on the back, etc.
- Use permanent ink
- Calculations and transformations are understandable
Original
- The first entry is the original data
- Place in the appropriate place, form, notebook, the first time
- If data is transcribed, note the location of the original source and confirm the accuracy of
- The electronic capture system must be validated
Accurate
- Complete and free from errors
- As observed or displayed
- Calculated vs. actual distinguished
- Estimates designated as such
- Appropriate use of significant figures
- Clearly identified
- Units, times, dates
- Unforeseen or unusual observations/events recorded
- Contextual and explanatory information is documented to the appropriate significance