GOOD LABORATORY

NOTEBOOK

PRACTICES

ARS Laboratory Notebooks are bound

notebooks ALWAYS

USE OFFICIAL ARS Laboratory Notebook(ARS FORM 1)

WHY NOTEBOOKS ARE

NECESSARYEstablishing ownership of Inventions Under CRADAS and DOE Bioenergy Research Centers (BRCs) Projects

Determining Inventorship

Overcoming References

Establishing Priority – First to Invent

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

ARS GUIDELINES (con’t)

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.

ARS GUIDELINES (con’t)

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

B. IMPORTANT!! CRADAs

REQUIRE SEPARATE ARS

NOTEBOOKIf you are conducting research on a CRADA, all information and data must be recorded in a separate ARS notebookthat is used only for that CRADA research.

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

C. IMPORTANT!! SEPARATE

NOTEBOOKS REQURED FOR

BRC PROJECTS

If you are conducting research on a BRC project, all information and data must be recorded in a separate ARS notebookthat is used only for that specific BRC research project.

If you are working on two different BRC Projects then you will have to use two different ARS notebooks.

D. NEW GUIDELINES FOR ARS

LABORATORY NOTEBOOK

ENTRIES

I. KEY NOTEBOOKS ENTRIES FOR PATENTABLE INVENTIONS

Date & Title of Experiment

Statement of Objective

Detailed Description of Experiment

Scientist’s Signature

Signature & Date of Witness

(NOT a coinventor)

ENTRIES (con’t)

II. A New Laboratory Notebook should include Title of the Project, Agreement Number, Laboratory Notebook Number, and in precise language the purpose and objective of each the experiments, general plans or procedures of each experiment and the date and time each experiment was done.

ENTRIES (con’t)

III. 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.

IV. 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.

ENTRIES (con’t)

V. All essential facts should be recorded

Equipment Used

Conditions

Times

Materials including source and quality

Yields

Characterizing Data

ENTRIES (con’t)

VI. 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.

ENTRIES (con’t)

VII. Date and Time of each experiment started should be recorded. If work carries over more than one day, each succeeding day’s entries shall reflect the time and date of same.

VIII. If Experiment requires more than one page, references to previous and following pages should be referenced so it can be followed.

ENTRIES (con’t)

IX. For standard or routine procedure, a reference to the location of a full description shall be made in the Laboratory Notebook

X. Conclusions and/or evaluation of results should be drawn if experiment(s) explore new conditions or are aimed at making a new composition

ENTRIES (con’t)

XI. Conclusions and/or evaluation of results is important for recognition of success is an important element in the reduction of practice of an invention.

XII. Unnecessary derogatory comments about results should not be made in Notebook as results may be valuable in a different way than anticipated

ENTRIES (con’t)

XIII. Analytical or other results should be copied into the record.

XIV. 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.

ENTRIES (con’t)

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

XVI. Enter all results, both good and bad. Copious descriptions with elaborate details are preferable. Better too much than too little. Original data is needed to prove new discoveries.

E. WITNESSING OF

NOTEBOOKS

WHYAn inventor’s 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

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.

WITNESSING (con’t)

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

WITNESSING (con’t)

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.

OFFICIAL ARS LABORATORY

NOTEBOOKS (ARS FORM 1)

The official ARS Laboratory Notebooks are available through your procurement officer from the Beltsville Service Center’s Central Suppy Store.

WWW.BCS.USDA.GOV

Available at no cost.