GOOD LABORATORY GOOD LABORATORY NOTEBOOK NOTEBOOK PRACTICESPRACTICES

ARS Laboratory ARS Laboratory Notebooks are Notebooks are

bound notebooks bound notebooks ALWAYSALWAYS

USE OFFICIAL ARS Laboratory NotebookUSE OFFICIAL ARS Laboratory Notebook(ARS FORM 1)(ARS FORM 1)

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WHY NOTEBOOKS ARE WHY NOTEBOOKS ARE NECESSARYNECESSARY

Record of ARS ResearchRecord of ARS Research

Records the original intent of a scientific Records the original intent of a scientific investigationinvestigationPreserves the experimental data and Preserves the experimental data and observations for future referenceobservations for future referenceAssists future researchers with the Assists future researchers with the understanding/reproduction of your understanding/reproduction of your experimental observationsexperimental observationsValuble resource for writing a paperValuble resource for writing a paper

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WHY NOTEBOOKS ARE WHY NOTEBOOKS ARE NECESSARY (con’t)NECESSARY (con’t)

Classical Evidentiary toolClassical Evidentiary tool

APHIS or FDA Approval ProcessesAPHIS or FDA Approval Processes

PatentsPatentsInventorship DeterminationInventorship Determination

Overcoming References during Patent ProsecutionOvercoming References during Patent Prosecution

Establishing First to InventEstablishing First to Invent

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A. OFFICIAL ARS NOTEBOOK A. OFFICIAL ARS NOTEBOOK GUIDELINESGUIDELINES

Use as a Daily Log for Research work plans Use as a Daily Log for Research work plans and resultsand results

Do not use any erasable medium such as a Do not use any erasable medium such as a pencil or erasable inkpencil or erasable ink

Make corrections by crossing through the Make corrections by crossing through the item and initialingitem and initialing

Do not remove any pages from the Do not remove any pages from the NotebookNotebook

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ARS GUIDELINES (con’t)ARS GUIDELINES (con’t)

Cross-reference instrument printouts when Cross-reference instrument printouts when such data is retained in a separate such data is retained in a separate location.location.

Date entry and initial each filled page. Date entry and initial each filled page. Periodically have entries witnessed with a Periodically have entries witnessed with a signature and date by another employee, signature and date by another employee, particularly when patentable information particularly when patentable information or data pertinent to regulatory activities or data pertinent to regulatory activities could possibly be entered.could possibly be entered.

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ARS GUIDELINES (con’t)ARS GUIDELINES (con’t)

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

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IMPORTANT!! IMPORTANT!! CRADAs and BRC PROJECTS CRADAs and BRC PROJECTS

REQUIRE SEPARATE ARS REQUIRE SEPARATE ARS NOTEBOOK NOTEBOOK

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

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IMPORTANT!! IMPORTANT!! CRADAs and BRC PROJECTS CRADAs and BRC PROJECTS

REQUIRE SEPARATE ARS REQUIRE SEPARATE ARS NOTEBOOKNOTEBOOK

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

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D. NEW GUIDELINES FOR ARS D. NEW GUIDELINES FOR ARS LABORATORY NOTEBOOK LABORATORY NOTEBOOK

ENTRIESENTRIESA WELL WRITTEN NOTEBOOK A WELL WRITTEN NOTEBOOK

SAVES TIMSAVES TIMEE

KEY NOTEBOOKS ENTRIESKEY NOTEBOOKS ENTRIESDate & Title of ExperimentDate & Title of Experiment

Statement of ObjectiveStatement of Objective

Detailed Description of ExperimentDetailed Description of Experiment

Scientist’s SignatureScientist’s Signature

Signature & Date of Witness Signature & Date of Witness

(NOT a coinventor)(NOT a coinventor)

DO NOT USE AN ERASEABLE MEDIUM DO NOT USE AN ERASEABLE MEDIUM Version 10/01/2009

EXAMPLE OF KEY EXAMPLE OF KEY NOTEBOOK ENTRYNOTEBOOK ENTRY

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ERASABLE MEDIUMERASABLE MEDIUM

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

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Results of Methanol SoakingResults of Methanol Soaking

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ENTRIES (con’t)ENTRIES (con’t)Experiments should be recorded in chronological Experiments should be recorded in chronological

order. order.

Skipped or blank pages or pages dated out of order Skipped or blank pages or pages dated out of order create a suspicion of tampering with the record.create a suspicion of tampering with the record.

Errors shall be crossed through with a single line Errors shall be crossed through with a single line and initialed. and initialed.

If the error is more than a few words, an If the error is more than a few words, an explanation of the error should be noted in the explanation of the error should be noted in the margin where the error is corrected.margin where the error is corrected.

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ENTRIES (con’t)ENTRIES (con’t)

ALL ESSENTIAL FACTS SHOULD BE ALL ESSENTIAL FACTS SHOULD BE RECORDEDRECORDED

Equipment UsedEquipment Used ConditionsConditions TimesTimes Materials including source and qualityMaterials including source and quality YieldsYields Characterizing DataCharacterizing Data

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ENTRIES (con’t)ENTRIES (con’t)

ABBREVIATIONS AND CODES ABBREVIATIONS AND CODES

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

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ENTRIES (con’t)ENTRIES (con’t)

DATE AND TIME OF EACH EXPERIMENT DATE AND TIME OF EACH EXPERIMENT SHOULD BE RECORDED.SHOULD BE RECORDED.

If work carries over more than one day, If work carries over more than one day, each succeeding day’s entries shall reflect each succeeding day’s entries shall reflect the time and date of same.the time and date of same.

If Experiment requires more than one page, If Experiment requires more than one page, reference should be made to previous and reference should be made to previous and following pages so that the experiment following pages so that the experiment can be followed. can be followed.

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ENTRIES (con’t)ENTRIES (con’t)

STANDARD OR ROUTINE STANDARD OR ROUTINE PROCEDURES PROCEDURES

A reference to the location of a full A reference to the location of a full description shall be made in the description shall be made in the Laboratory NotebookLaboratory Notebook

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Example of Standard ProcedureExample of Standard Procedure

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ENTRIES (con’t)ENTRIES (con’t)

CONCLUSIONS AND/OR CONCLUSIONS AND/OR EVALUATION OF RESULTS EVALUATION OF RESULTS

a. Should be drawn if experiment(s) a. Should be drawn if experiment(s) explore new conditions or are explore new conditions or are aimed at making a new compositionaimed at making a new composition

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ENTRIES (con’t)ENTRIES (con’t)

CONCLUSIONS AND/OR CONCLUSIONS AND/OR EVALUATION OF RESULTS (con’t)EVALUATION OF RESULTS (con’t)

Ib. Is important for recognition of Ib. Is important for recognition of success and is an important element success and is an important element in the reduction of practice of an in the reduction of practice of an invention.invention.

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ENTRIES (con’t)ENTRIES (con’t)

UNNECESSARY DEROGATORY UNNECESSARY DEROGATORY COMMENTSCOMMENTS

Should not be made in the Notebook Should not be made in the Notebook as results may be valuable in a as results may be valuable in a different way than anticipateddifferent way than anticipated

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ENTRIES (con’t)ENTRIES (con’t)

ANALYTICAL OR OTHER RESULTS ANALYTICAL OR OTHER RESULTS

Should be copied into the record.Should be copied into the record.

If attached to the record, the page If attached to the record, the page should be taped in, and a signature, should be taped in, and a signature, date, and time should be written in date, and time should be written in permenant ink across tape and on permenant ink across tape and on page on either end of tape.page on either end of tape.

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ENTRIES: ATTACHMENT OF ENTRIES: ATTACHMENT OF ANALYTICAL DATAANALYTICAL DATA

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ENTRIES (con’t)ENTRIES (con’t)

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

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Example of Unused Portion of Example of Unused Portion of PagePage

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Entries (con’t)Entries (con’t)

Enter all results, both good and bad. Enter all results, both good and bad. Failed experiments can provide insight Failed experiments can provide insight

and ideas for future experiments or and ideas for future experiments or conclusionsconclusions

Copious descriptions with elaborate Copious descriptions with elaborate details are preferable. details are preferable. Enough detail should be given so that Enough detail should be given so that

another researcher could repeat your another researcher could repeat your work based on your notebook entries and work based on your notebook entries and make the same observationsmake the same observations

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ELECTRONIC RECORDSELECTRONIC RECORDS

Store electronic records on a read-only Store electronic records on a read-only optical diskoptical disk

Back up and write protect electronic Back up and write protect electronic datadata

Reference location of electronic data Reference location of electronic data in a signed, dated and witnessed in a signed, dated and witnessed handwritten notebookhandwritten notebook

Store Electronic Records in a safe Store Electronic Records in a safe repositoryrepository

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ELECTRONIC RECORDS ELECTRONIC RECORDS (con’t)(con’t)

Electronic or digital signature Electronic or digital signature software may be employed to software may be employed to enhance the credibility of the enhance the credibility of the electronic recordelectronic record

Use hardware/software that prevents Use hardware/software that prevents the ability to edit original research the ability to edit original research descriptionsdescriptions

Ensure security to prevent Ensure security to prevent unauthorized access to the systemunauthorized access to the system

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EXAMPLE NOTEBOOK PAGEEXAMPLE NOTEBOOK PAGE

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E. E. WITNESSING OF NOTEBOOKS

WHYWHYAn inventor’s unsupported testimony on his or her behalf is An inventor’s unsupported testimony on his or her behalf is

considered under the law to be self-serving.considered under the law to be self-serving.

WHOWHO Witness is someone who has observed and understood the Witness is someone who has observed and understood the

experimentexperiment

Should be a person who can reasonably be expected to be Should be a person who can reasonably be expected to be available for several years after the date of signingavailable for several years after the date of signing

WITNESS CANNOT BE A CO-INVENTORWITNESS CANNOT BE A CO-INVENTOR

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E. WITNESSINGE. WITNESSING

When record is incomplete or if there is a When record is incomplete or if there is a delay before work proceeds causing record delay before work proceeds causing record to be incomplete, Notebook page still to be incomplete, Notebook page still should be signed and witnessed promptly should be signed and witnessed promptly before the record in completed.before the record in completed.

Signatures must be dated.Signatures must be dated.

Witnessing provides corroboration of the Witnessing provides corroboration of the existence of the record at the date of existence of the record at the date of signing by a person who can testify later, if signing by a person who can testify later, if needed.needed.

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WITNESSING (con’t)WITNESSING (con’t)

Witnessing should be done no more Witnessing should be done no more than a few days after entries are than a few days after entries are made.made.

Witnessing that is unduly delayed is a Witnessing that is unduly delayed is a little better than no witnessing.little better than no witnessing.

The witness should read and The witness should read and understand entries understand entries

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WITNESSING (con’t)WITNESSING (con’t)

Witness should sign and date any new Witness should sign and date any new ideas, plans, procedures, sketches, etc. that ideas, plans, procedures, sketches, etc. that have been entered into notebook.have been entered into notebook.

When no witness is available and the When no witness is available and the experiment shows results of possible experiment shows results of possible patentable importance, the procedure patentable importance, the procedure should be repeated under the scientists should be repeated under the scientists supervision as soon as possible and the supervision as soon as possible and the experiment recorded in both the scientists experiment recorded in both the scientists and co-workers Laboratory Notebook with and co-workers Laboratory Notebook with proper signatures and dates.proper signatures and dates.

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OFFICIAL ARS LABORATORY OFFICIAL ARS LABORATORY NOTEBOOKS (ARS FORM 1)NOTEBOOKS (ARS FORM 1)

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

WWW.BCS.USDA.GOV

Available at no cost.Available at no cost.

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