Good data are required for patent writing, litigation, and product registration with the USDA, EPA & FDA. Government requirements are described in Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), and Good Laboratory Practice regulations (GLP) used by these agencies. Your data may have to be explained, defended, reconstructed or repeated without your assistance, so others must be able to understand what you did. Monsanto’s and Pfizer’s recordkeeping guidelines are among the most stringent in the biotech field and, therefore, will be used as the recordkeeping guidelines of the SLCC Biotechnology Program.
ü All persons recording in the notebook must also sign the title page and give an example of initials used.
ü If you have properly linked all pages as required, record only the first page number of each multi-page experiment.
ü The objective or purpose of the experiment/lab
ü The plan, outline or a flow diagram of the lab
ü The step-by-step procedure
ü The raw data produced
ü The results, including graphs, tables, figures, photos and/or drawings
ü The conclusion, which should include the biological and chemical concepts involved, whether the objective was met, any problems experienced and suggestions for further experimentation.
ü Entries should be made as the experiment proceeds but no later than as soon as it is done or when an idea is conceived.
ü Raw data: original of handwritten information or a printout from equipment, such as a description of your observations, a description of your procedures, a description of the events.
ü Calculated data: derived from a calculation or statistical evaluation of the raw data
ü Transcribed data: copied raw or calculated data.
ü Objectives, ideas, experimental plans or outlines, preparations, procedures, data, observations, calculations, discussions, conclusions, future plans and potential uses
ü What actually happened
ü Notes of unexpected results or observations
ü Deviations to a planned protocol
ü All measurements and important test conditions (weights, volumes, temperature, etc.)
ü All units (ml, g mg, etc.)
ü Indicate if the numbers are estimated, rather than measured
ü Indicate if the numbers were calculated and provide the equation.
ü If using Excel spreadsheets, print out the formula(s).
ü Indicate if a number has been rounded or truncated.
ü Decide before you begin what the critical events will be so that you can record them, i.e., in a table, as proof that an SOP or previous procedure was followed.
ü Directly into your notebook – not on scraps of paper, post-it notes, etc
ü In black indelible ink – although Monsanto now allows blue ink, Pfizer still requires black.
ü Make entries only in the ruled areas of the numbered pages.
ü Unnumbered pages can not be used – they are not copied for legal proceedings.
ü Only one experiment per page – do not mix different studies on the same page.
ü Attach forms or printouts
ü Attach only to numbered pages within the ruled area only
ü Taped on at least 2 sides
ü Fully exposed (no folding)
ü NOT covering any previously recorded entries
ü With hash marks on at least two corners
ü Write the notebook and page number on the attachment
ü Sign and date along the edge
ü Record your data on the same day it is generated, not after the fact.
ü A single page can cover events from more than one day, but the dates must be indicated on each event.
ü The person making the entries must sign the page.
Important materials must be noted.
ü The importance of a material is related to its impact on the reconstructability and repeatability of the experiment.
ü Variability between batches or lots is often a prime consideration here.
ü Do not use simple terms like “the buffer” but write the name of the buffer.
ü List the purity, concentration and other pertinent information
ü List the source or catalogue number of the product used.
ü For complex solutions, the recipe or a record of the preparation should be recorded.
ü Analytical instruments
ü Software and version number
ü Unique equipment ID numbers
ü Date of last maintenance
ü Date of last calibration
ü Date of last performance check
The following can be referenced, by page number, rather than copying completely:
ü A previously run procedure that was correctly recorded in your notebook
ü A Standard Operating Procedure (SOP)
If any deviations were performed, they must be so noted.
As fact, not as opinion
ü Fact: “No reaction was observed.” Opinion: “These two chemicals don’t react.”
ü Fact: “Expected results were not obtained.” Opinion: “No good.”
ü Fact: “Under these conditions, the reaction was unsuccessful.” Opinion: “Failed.”
ü Within two weeks of completion of an experiment or procedure.
ü By someone outside your team
ü Is it legible to others, not just to you?
ü Is it clear and detailed enough so that a person in the same discipline could understand it and repeat it?
ü Have you included drawings and flowcharts to provide clarity in complicated experiments, processes and equipment setups?
ü Are all abbreviations defined or obvious? A preprinted list of abbreviations should be kept and attached in the front of your notebook after the table of contents.
ü Unused portions of > 3 lines
ü Unused fields in forms and tables should be lined-out or marked as N/A.
ü NEVER use white-out
ü NEVER erase
ü NEVER write-over
ü NEVER discard or replace attached supplementary data
ü ALWAYS record a defensible reason for the correction/edit
ü ALWAYS circle the reason
ü ALWAYS add your dated initials to corrected/edited data after the circled reason
ü In a company or academic lab, your notebook is not your own property and must not be removed from the premises.
ü This is the one area where we will deviate from the rules – because this is a class, and you must study for tests and answer questions about labs you perform, you will be allowed to take your notebooks home with you.
ü YOU SHOULD NOT complete data outside of class, however. All data must be recorded on the day it is generated BEFORE leaving the lab.