GOOD LABORATORY NOTEBOOK PRACTICES

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GOOD LABORATORY NOTEBOOK PRACTICES

• ARS Laboratory Notebooks are bound notebooks
• ALWAYS
• USE OFFICIAL ARS Laboratory Notebook
• (ARS FORM 1)

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WHY NOTEBOOKS ARE NECESSARY

• Record of ARS Research
• Records the original intent of a scientific
  investigation
• Preserves the experimental data and observations
  for future reference
• Assists future researchers with the
  understanding/reproduction of your experimental
  observations
• Valuble resource for writing a paper

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WHY NOTEBOOKS ARE NECESSARY (cont)

• Classical Evidentiary tool
• APHIS or FDA Approval Processes
• Patents
• Inventorship Determination
• Overcoming References during Patent Prosecution
• Establishing First to Invent

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A. OFFICIAL ARS NOTEBOOK GUIDELINES

• Use as a Daily Log for Research work plans and
  results
• Do not use any erasable medium such as a pencil
  or erasable ink
• Make corrections by crossing through the item and
  initialing
• Do not remove any pages from the Notebook

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ARS GUIDELINES (cont)

• Cross-reference instrument printouts when such
  data is retained in a separate location.
• Date entry and initial each filled page.
  Periodically have entries witnessed with a
  signature and date by another employee,
  particularly when patentable information or data
  pertinent to regulatory activities could possibly
  be entered.

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ARS GUIDELINES (cont)

• THIS NOTEBOOK AND THE INFORMATION CONTAINED
  THEREIN IS THE PROPERTY OF THE AGRICULTURAL
  RESEARCH SERVICE.

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IMPORTANT!! CRADAs and BRC PROJECTS REQUIRE
SEPARATE ARS NOTEBOOK

• If you are conducting research under a CRADA or
  BRC project, all information and data must be
  recorded in a separate ARS notebook that is used
  only for that CRADA or BRC research.

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IMPORTANT!! CRADAs and BRC PROJECTS REQUIRE
SEPARATE ARS NOTEBOOK

• If you are working on two different CRADAs or BRC
  projects then you will have to use two ARS
  notebooks in addition to the ones you would use
  for non-CRADA , non-BRC research.

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D. NEW GUIDELINES FOR ARS LABORATORY NOTEBOOK
ENTRIES

• A WELL WRITTEN NOTEBOOK SAVES TIME
• KEY NOTEBOOKS ENTRIES
• Date Title of Experiment
• Statement of Objective
• Detailed Description of Experiment
• Scientists Signature
• Signature Date of Witness
• (NOT a coinventor)
• DO NOT USE AN ERASEABLE MEDIUM

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EXAMPLE OF KEY NOTEBOOK ENTRY
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ERASABLE MEDIUM

• Many pens bleed when wet, and you should avoid
  using them in the laboratory where spills
  invariably occur. I did a quick experiment to
  demonstrate this (e.g., soaking in methanol), and
  to determine which pens are satisfactory for
  keeping a notebook. The results are in the figure
  below

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Results of Methanol Soaking
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ENTRIES (cont)

• Experiments should be recorded in chronological
  order.
• Skipped or blank pages or pages dated out of
  order create a suspicion of tampering with the
  record.
• Errors shall be crossed through with a single
  line and initialed.
• If the error is more than a few words, an
  explanation of the error should be noted in the
  margin where the error is corrected.

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ENTRIES (cont)

• ALL ESSENTIAL FACTS SHOULD BE RECORDED
• Equipment Used
• Conditions
• Times
• Materials including source and quality
• Yields
• Characterizing Data

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ENTRIES (cont)

• ABBREVIATIONS AND CODES
• should be chosen and used in an unambiguous and
  consistent way and non-standard abbreviations and
  codes should be defined in the Laboratory
  Notebook before using the same.

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ENTRIES (cont)

• DATE AND TIME OF EACH EXPERIMENT SHOULD BE
  RECORDED.
• If work carries over more than one day, each
  succeeding days entries shall reflect the time
  and date of same.
• If Experiment requires more than one page,
  reference should be made to previous and
  following pages so that the experiment can be
  followed.

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ENTRIES (cont)

• STANDARD OR ROUTINE PROCEDURES
• A reference to the location of a full
  description shall be made in the Laboratory
  Notebook

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Example of Standard Procedure
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ENTRIES (cont)

• CONCLUSIONS AND/OR EVALUATION OF RESULTS
• a. Should be drawn if experiment(s) explore
  new conditions or are aimed at making a new
  composition

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ENTRIES (cont)

• CONCLUSIONS AND/OR EVALUATION OF RESULTS (cont)
• Ib. Is important for recognition of success and
  is an important element in the reduction of
  practice of an invention.

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ENTRIES (cont)

• UNNECESSARY DEROGATORY COMMENTS
• Should not be made in the Notebook as
  results may be valuable in a different way than
  anticipated

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ENTRIES (cont)

• ANALYTICAL OR OTHER RESULTS
• Should be copied into the record.
• If attached to the record, the page
  should be taped in, and a signature, date, and
  time should be written in permenant ink across
  tape and on page on either end of tape.

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ENTRIES ATTACHMENT OF ANALYTICAL DATA
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ENTRIES (cont)

• An unused portion of a page should be struck out
  to forestall any challenge that the record has
  been augmented at a later date.

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Example of Unused Portion of Page
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Entries (cont)

• Enter all results, both good and bad.
• Failed experiments can provide insight and ideas
  for future experiments or conclusions
• Copious descriptions with elaborate details are
  preferable.
• Enough detail should be given so that another
  researcher could repeat your work based on your
  notebook entries and make the same observations

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ELECTRONIC RECORDS

• Store electronic records on a read-only optical
  disk
• Back up and write protect electronic data
• Reference location of electronic data in a
  signed, dated and witnessed handwritten notebook
• Store Electronic Records in a safe repository

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ELECTRONIC RECORDS (cont)

• Electronic or digital signature software may be
  employed to enhance the credibility of the
  electronic record
• Use hardware/software that prevents the ability
  to edit original research descriptions
• Ensure security to prevent unauthorized access to
  the system

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EXAMPLE NOTEBOOK PAGE
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E. WITNESSING OF NOTEBOOKS

• WHY
• An inventors unsupported testimony on his or her
  behalf is considered under the law to be
  self-serving.
• WHO
• Witness is someone who has observed and
  understood the experiment
• Should be a person who can reasonably be expected
  to be available for several years after the date
  of signing
• WITNESS CANNOT BE A CO-INVENTOR

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E. WITNESSING

• When record is incomplete or if there is a delay
  before work proceeds causing record to be
  incomplete, Notebook page still should be signed
  and witnessed promptly before the record in
  completed.
• Signatures must be dated.
• Witnessing provides corroboration of the
  existence of the record at the date of signing by
  a person who can testify later, if needed.

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WITNESSING (cont)

• Witnessing should be done no more than a few days
  after entries are made.
• Witnessing that is unduly delayed is a little
  better than no witnessing.
• The witness should read and understand entries

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WITNESSING (cont)

• Witness should sign and date any new ideas,
  plans, procedures, sketches, etc. that have been
  entered into notebook.
• When no witness is available and the experiment
  shows results of possible patentable importance,
  the procedure should be repeated under the
  scientists supervision as soon as possible and
  the experiment recorded in both the scientists
  and co-workers Laboratory Notebook with proper
  signatures and dates.

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OFFICIAL ARS LABORATORY NOTEBOOKS (ARS FORM 1)

• The official ARS Laboratory Notebooks are
  available through your procurement officer from
  the Beltsville Service Centers Central Suppy
  Store.
• WWW.BCS.USDA.GOV
• Available at no cost.