GOOD LABORATORY NOTEBOOK PRACTICES ARS Laboratory Notebooks are bound notebooks ALWAYS USE OFFICIAL ARS Laboratory Notebook (ARS FORM 1) Version 10/01/2009

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 Version 10/01/2009

WHY NOTEBOOKS ARE NECESSARY (con’t) Classical Evidentiary tool APHIS or FDA Approval Processes Patents Inventorship Determination Overcoming References during Patent Prosecution Establishing First to Invent Version 10/01/2009

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 Version 10/01/2009

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. Version 10/01/2009

ARS GUIDELINES (con’t) THIS NOTEBOOK AND THE INFORMATION CONTAINED THEREIN IS THE PROPERTY OF THE AGRICULTURAL RESEARCH SERVICE. Version 10/01/2009

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. Version 10/01/2009

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. Version 10/01/2009

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 Scientist’s Signature Signature & Date of Witness (NOT a coinventor) DO NOT USE AN ERASEABLE MEDIUM Version 10/01/2009

EXAMPLE OF KEY NOTEBOOK ENTRY Version 10/01/2009

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: Version 10/01/2009

Results of Methanol Soaking Version 10/01/2009

ENTRIES (con’t) 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. Version 10/01/2009

ALL ESSENTIAL FACTS SHOULD BE RECORDED ENTRIES (con’t) ALL ESSENTIAL FACTS SHOULD BE RECORDED Equipment Used Conditions Times Materials including source and quality Yields Characterizing Data Version 10/01/2009

ENTRIES (con’t) 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. Version 10/01/2009

DATE AND TIME OF EACH EXPERIMENT SHOULD BE RECORDED. ENTRIES (con’t) DATE AND TIME OF EACH EXPERIMENT SHOULD BE RECORDED. If work carries over more than one day, each succeeding day’s 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. Version 10/01/2009

ENTRIES (con’t) STANDARD OR ROUTINE PROCEDURES A reference to the location of a full description shall be made in the Laboratory Notebook Version 10/01/2009

Example of Standard Procedure Version 10/01/2009

CONCLUSIONS AND/OR EVALUATION OF RESULTS ENTRIES (con’t) CONCLUSIONS AND/OR EVALUATION OF RESULTS a. Should be drawn if experiment(s) explore new conditions or are aimed at making a new composition Version 10/01/2009

CONCLUSIONS AND/OR EVALUATION OF RESULTS (con’t) ENTRIES (con’t) CONCLUSIONS AND/OR EVALUATION OF RESULTS (con’t) Ib. Is important for recognition of success and is an important element in the reduction of practice of an invention. Version 10/01/2009

UNNECESSARY DEROGATORY COMMENTS ENTRIES (con’t) UNNECESSARY DEROGATORY COMMENTS Should not be made in the Notebook as results may be valuable in a different way than anticipated Version 10/01/2009

ANALYTICAL OR OTHER RESULTS ENTRIES (con’t) 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. Version 10/01/2009

ENTRIES: ATTACHMENT OF ANALYTICAL DATA Version 10/01/2009

ENTRIES (con’t) An unused portion of a page should be struck out to forestall any challenge that the record has been augmented at a later date. Version 10/01/2009

Example of Unused Portion of Page Version 10/01/2009

Entries (con’t) 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 Version 10/01/2009

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 Version 10/01/2009

ELECTRONIC RECORDS (con’t) 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 Version 10/01/2009

EXAMPLE NOTEBOOK PAGE Version 10/01/2009

E. WITNESSING OF NOTEBOOKS WHY An 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 Version 10/01/2009

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. Version 10/01/2009

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 Version 10/01/2009

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. Version 10/01/2009

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. Version 10/01/2009