General Guidelines

• Do's and Don'ts For Keeping Lab Notebooks
• Do's and Don'ts For Keeping E-Lab Notebooks

Do's and Don'ts for Keeping Lab Notebooks By J. Peter Fasse Fish & Richardson, P.C. A laboratory notebook is a vital record of events leading to a patentable invention. The recorded information can establish dates of conception and reduction to practice of a technology as well as the inventorship of a patent claiming the technology. Below are fourteen rules you should follow when keeping lab notebooks.

#1 — Do use bound books Inventors should use permanently bound notebooks, e.g., notebooks with spiral or glue bindings. If loose-leaf sheets are used, they should be consecutively numbered and each page should be dated, signed, and witnessed.

#2 — Do sign and date Each notebook should be signed and dated on the inside front cover to indicate the first day the recipient started using the notebook. Each entry should be signed and dated. An independent witness, i.e., someone who understands the technology but will not be named as a co-inventor of the invention, should sign and date each entry after the statement: “Read and understood by ________.” (The witness should preferably sign the entries on a contemporaneous or fairly contemporaneous basis, but entries can also be reviewed, signed, and dated on a periodic, e.g., weekly or monthly, basis.)

#3 — Do use ink Notebook entries should be made in ink and in chronological order. Entries should not be erased or "whited out." If an entry contains an error, a line should be drawn through the error and new text should continue in the next available space.

#4 — Don’t leave blank spaces Blank gaps between entries should be avoided. If a blank space is left on a page, a line or cross should be drawn through the blank space, and the page dated to prevent subsequent entries.

#5 — Don’t modify Prior entries should not be modified at a later date. If data were omitted, the new data can be entered under a new date and cross-referenced to the previous entry. Record experiments when they are performed.

#6 — Do use past tense Use the past tense (e.g., "was heated") to describe the experiments that were actually performed.

#7 — Do explain abbreviations and special terms Explain all abbreviations and terms that are nonstandard. Explain in context, in a table of abbreviations, or in a glossary.

#8 — Do staple attachments Attachments such as graphs or computer printouts should be permanently affixed in the notebook (e.g., by stapling), and both the attachment and the notebook page signed and dated. If the attachment cannot be stapled, it should be placed in an envelope and the envelope stapled to the notebook page. The envelope and page should then be signed and witnessed making reference to the attachment being placed in the envelope.

#9 — Don’t remove originals No original pages should be removed from the notebook.

#10 — Do outline new experiments When a new project or experiment is started, the objective and rationale should be briefly outlined (e.g., in a short paragraph or by providing a flowchart).

#11 — Do record lab meeting discussions Relevant discussions from lab meetings should be recorded as should ideas or suggestions made by others. The names of the people making the ideas and suggestions should be carefully documented. This information may be important in establishing inventorship.

#12 — Do provide detail Record test descriptions, including preferred operating conditions, control conditions, operable and preferred ranges of conditions, and alternate specific materials; test results and an explanation of the results; and photos or sketches of the results or the test device. Any conclusions should be short and supported by the factual data. Opinions or speculation about the invention should be avoided.

#13 — Do track notebooks Ideally, each lab should maintain a catalogue of notebooks in which each notebook is assigned a number, and the name of the author of each notebook is recorded. Further, the date the author received the notebook as well as the date the notebook was completed and turned in should be recorded. Upon leaving the lab, the author should return all notebooks checked out by or to him.

#14 — Do save completed notebooks All completed notebooks should be indexed (e.g., by number, by author, by subject area) and safely kept in a central repository, together with corresponding patent applications or patents. Lab notebooks that relate to inventions on which patents have been granted should be kept for the life of the patent plus six years. © Copyright 2000 Fish & Richardson P.C. All rights reserved.

Do's and Don'ts for Keeping E-Lab Notebooks By Diane L. Gardner Fish & Richardson, P.C. Laboratory notebooks provide important legal information as well as scientific or engineering data. Lab notebooks may contain evidence related to priority of patent claims, as well as verification of compliance with FDA guidelines for good laboratory practices (GLPs) and good manufacturing procedures (GMPs). Electronic lab notebooks are not always acceptable in legal proceedings as a substitute for original, permanently-bound, handwritten records, particularly with respect to proving dates of invention in patent cases. Until electronic lab notebooks are fully approved by the courts, a hard copy of all data should be maintained. Following are guidelines to consider if you maintain electronic versions of laboratory notebooks.

#1 - Do adopt a written policy for electronic record-keeping Establish a written policy that is furnished to each employee and adopt the policy as part of your normal business routine. Review compliance periodically with employees.

#2 - Do retain permanent back-up copies Back-up all electronic data to a clearly labeled "write once" media. Store the back-up copy in a safe place free from magnetic fields or other corruptive conditions. Print computer generated data to paper and label, sign (with a witness), and date the hard copy and permanently attach the hard copy to the handwritten notebook. Reference all electronic data in the handwritten notebook. Store the hard and soft copies with a record custodian who can vouch for their integrity. Maintain all records/data for the duration of your established document retention period.

#3 - Do maintain computer system integrity Computer systems should be regularly validated to ensure reliability, accuracy, and consistent performance. Precautions should be taken against the importation of viruses.

#4 - Don’t allow electronic records to be modified Hardware and/or software should be developed or used which prevents the ability of editing original research descriptions, i.e., WORM - Write Once, Read Many times. Additionally, all electronic records should be time-stamped by a separate server having highly restricted access.

#5 - Don’t allow unauthorized computer access Prevent unauthorized access to your computer system. Use key and screen locks, as well as removable storage devices that can be locked away when not in use. Electronic/digital signature or encryption hardware and/or software will enhance the credibility of the electronic records. Limit access to the computer system to authorized personnel who have a genuine need for access. Limit distribution and use of information stored in the system. Frequently change individual user codes and passwords used to log on to the system and delete user codes when employees leave. Require periodic reports on who has accessed the system, and review the reports for any unauthorized persons. © Copyright 2000 Fish & Richardson P.C. All rights reserved.