1

U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Legally, invention is

a two­step process.

The first step is conception of the

invention and the second step is

“reduction to practice” of the invention. An

inventor isa person who contributes to the

conception of the invention. Conception is

defined as the formation in the mind of an

inventor ofa definite and permanent idea of

the complete invention. Once the invention

is conceived,a person of ordinary skill in the

inventor’s field must be able to reduce the

invention to practice, i.e., make use of the

invention based on this conception.

Therefore, it is important that the scientist

capture his/her ideas/conception of an

invention in written format. Laboratory

notebooks, if used properly, can serve as the

basis of conception. They can also serve to

help in patent prosecution by enabling the

scientist to swear behinda cited reference.

National Cancer Institute
 

Technology Transfer Center
 

6120 Executive Blvd., Suite 450
 

Rockville, MD 20852
 

Telephone: (301) 496­0477
 

Fax: (301) 402­2117
 

National Cancer Institute­Frederick
 

Technology Transfer Center
 

1003 W. 7th Street, Suite 500

Frederick, MD 21701

Telephone: (301) 846­5465

Fax: (301) 846­6820

web site: http://ttc.nci.nih.gov

National Cancer Institute

U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Technology Transfer Center

Guide For

Keeping

Laboratory

Records

Guide For

Keeping

Laboratory

Records

Printed October 2009
ab notebooks.

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trademarks, code or unfamiliar jargon.

❚ Do use a bound noteb
 

❚ Do write legibly.
 

❚ Do write in ink.
 

❚ Do explain acronyms,
 

❚ Do attach to your lab notebook loose notes, emails, letters,
 

Best practices for NIH scientists

(researchers, technicians, fellows, visiting

scientists) to follo f k i l b

records and noteb

graphs, figures and charts containing any part of conception

of an idea or result of an experiment.

❚ Do title, sign and date each attachment, as well as each

laboratory notebook page.

❚ Do record the objective of an experiment as well as the

results obtained in as much detail as possible.

❚ Do have at least one non­inventor person who is familiar

with your field sign and date each page, stating that he/she

has “read and understood” your work.

❚ Do obtain a signed and dated statement from collaborators

and/or contractors who carry

out the experiments you

designed, stating "experiments

run by [insert contractor/

collaborator name], under the

direction of [insert the

experiment designer's name]”.

❚ Do record thoughts,

conversations, lab meeting

discussions, contractor oral

reports and discussions, as

well as wild speculations

and future plans.

❚ Do write in the active voice.

graphs and/or charts over them
 

❚ Do not write in the passive voice.
 

❚ Do not use words such as “obvious” or “abandoned” as they have
 

❚ Do not use binders, loose leaf o

notebooks.
 

❚ Do not blot out or erase mistak
 

❚ Do not modify the data.
 

❚ Do not rip pages out.
 

❚ Do not skip pages
 

❚ Do not leave a page blank.
 

❚ Do not cover any writings in th
 

❚ Do report completed experiments in the past tense.
 

❚ Do give cross references to previous experiments and/or projects.
 

❚ Do use a table of contents to provide cross references.
 

❚ Do keep your lab notebook under lock and key when you are not in
 

the lab.
 

❚ Do track and save completed l
 

tremendous legal significance.

Some tips for electronic notebooks:

❚ Do clearly define what you/your lab mean by electronic notebooks.

To some, data generated on a computer and affixed to a paper

notebook is an electronic notebook. To others, saving data on the

desktop or hard drive of their computer is an electronic lab

notebook. Yet to a third group, a particular software, e.g.,

LabTrack, is an electronic notebook.

❚ Do adopt an official procedure for electronic record keeping. Who will

be the custodian of the electronically stored data? Is there a backup?

❚ Do back up and write­protect all electronic data.

❚ Do retain all electronic copies for the duration of the appropriate

document retention period.

❚ Do store your electronic notebook contents on unchangeable

mediums, e.g., CD­R, or in an electronic archive that cannot be

modified.

❚ Do use software/

hardware which

prevents editing the

original document, i.e.,

WORM (Write Once,

Read Many).

❚ Do time stamp your

entries.

❚ Do restrict access to the

electronic notebook

using key and screen

locks, and/or

passcodes.

❚ Do associate the

identity of each author

and/or witness with each record automatically.

❚ Do not create and store records randomly on disks, desktops,

or hard drives.

❚ Do not store records on media that have limited shelf­life.

❚ Do not allow access to the electronic records by unauthorized

personnel.

❚ Do not rely on methods of

dating your entries that can

be altered.

❚ Do not alter any portion of

an electronic document.