Guidelines for keeping

Laboratory Notebooks

Khushwant Yadav, Ph.D.

SVKM’s NMIMS
Purpose of Laboratory Notebook
A laboratory notebook provides a permanent record of research, ideas, concepts, data, analysis, and/or
observations. It is a legal record of your work and may be used as evidence for patent !ling, patent
protection, or other legal purposes. Documentation and maintenance of your records is a fundamental
part of GLP (Good Laboratory Practice) and is essential for the management and protection of intellectual
property rights.
The proper use of a laboratory notebook will ensure that the progress from conception to reduction to
practice can be retraced in a chronological and logical manner, thus providing a solid basis for patent
purposes. Moreover, the contents of the laboratory notebook must be able to withstand any challenges to
their validity or accuracy

i. To record methods and results of experiments so that one can go back and figure out what was done.
ii. Another person can interpret results.
iii.The lab notebook is important in patent review.
iv. A well kept notebook provides a reliable reference for writing up materials and methods and results
for a study.
v. It is a legally valid record that preserves your rights or those of an employer or academic investigator
to your discoveries.
vi. A comprehensive notebook permits one to reproduce any part of a methodology completely and
accurately.
Ownership
• Generally, the notebook should not leave the laboratory
• The notebook belongs to the lab and institution

Type and Format of Notebook

The bound notebook is the gold standard and will be adopted
in laboratory
With Pages Numbered pages.
Ink not Pencil & Mistakes
• Ballpoint pen with black ink is best
• Pencil writing can be erased (harder to prove authenticity)
• Write legibly
• Mistakes? Cross them out with a single line.
White-Out and blacking out is not acceptable.
Content of the Laboratory Notebook
1. Table of Contents
• Title • Date • Page Number
2. Date of Experiment
3. Title of Experiment (e.g., Serial knock-down of DIAP1 by RNAi)
4. Purpose (e.g. To determine the relationship between the amount of RNA- used against DIAP1
and the amount of cell death.)
5. Materials and Methods
• Protocol • Written • Pasted • May refer to previous protocol in notebook (note
any changes) • Write before you begin procedure • Amend as you go through the
experiment • List any calculations
6. Observations and Results
• Everything that happens or doesn’t happen is data. • Any writing that will facilitate
data entry should be planned out in advance • Results may include: • Tables • Charts •
Graphs • Printouts • Pictures • Gels • Films • Calculations
7. Discussion and Conclusion
• Discuss results and implications of data. • Prepare a conclusion. How did the
experiment go? • What to do next?
Maintenance
1. Record everything ASAP
2. Weekly Check-Up
3. Attach data/printout/films
4. Create tables and graphs
5. Summary for the Week
6. Record experiment in Table of Contents
7. Make plan for the following week
Laboratory notebooks
Laboratory notebooks should be provided to each researcher. Each notebook should
have a number and be assigned to an individual researcher, who is the only person
who should enter data in the book. Only one project should be entered in each
notebook. Pages should not be removed or replaced.

Signing for the book

The researcher should sign and date receipt of the book on the inside cover.
Signing daily entries and witness signatures
a) Entries should be dated and signed by the researchers on the day the work is
conducted.
b) All entries require witness signatures on a weekly basis (signature to be dated).
The witness should understand the work but should not be directly involved in
the project so that he/she would not be deemed a co-inventor on any patent(s)
arising from the research.
Recording data
a) Enter all research data directly into the laboratory notebook where possible.
b) Explain any unusual abbreviations.
c) Entries should be legible and understandable to a co-worker.
d) Entries must be in permanent black or blue ink to facilitate legibility,
photocopying, etc.
e) Leave at least a half-inch margin at the inside (bound) edge of each page, to
facilitate photocopying. Keep entries inside the printed margins of each page.
f) Do not erase or use correction fluid. Strike out errors with a single line through
the mistake so that it is still legible; enter the corrected word(s) or value(s)
above the error, indicating the reason for the correction. Initial and date all
corrections.
g) Any unused pages or portions of pages must be closed out with a diagonal line
and dated with the researcher’s initials. Do not skip pages with the intention of
filling in data at a later date.
Organising data
a) Only one project may be recorded in each book. Researchers should maintain a
current table of contents or running index within the book, including date, experiment
number, objective /subject and page number.
b) When a book is closed out, a cross-reference to the succeeding notebook should be
entered (eg; ‘Continued to notebook number:…’).
c) With each new book, the researcher should cross-reference the previous notebook
(eg; ‘Continued from notebook number:…’).
d) For each new page, enter the title, project name/number and date.
e) Only one date should be used per page.
f) For patent purposes, records of new experiments should always be started on a new
page and dated at the onset of each experiment. The purpose/objective of the
experiment must be stated clearly.
g) If the experiment continues over more than one day, each entry must be dated and
continuation pages must be clearly annotated. For patent purposes, each page should
not contain entries for more than one day.
h) Only if absolutely necessary should new entries be added to previous pages, when
subsequent work of later date is already recorded on succeeding pages. Backdating of
these entries is strictly prohibited – the actual date of entry should be used.
Organising ancillary documentation
a) Where possible, supporting data should be affixed to the notebook.
b) Attach inserts (folded graphs, raw data tables, or computer printouts) with
transparent tape, glue or staples. Care should be taken that the tape does not
cover data and that inserts are not affixed in a manner that would hinder
photocopying. Sign and date the insert and notebook page (along the seam).
c) A form of binder, notebook, folder, or envelope must be used for organisation
and traceability of ancillary documentation (raw data sheets and other
supporting documentation) that cannot feasibly be incorporated into bound
notebooks, but are needed as permanent records of specific experiments.
d) In all cases, ancillary documentation must be cross-referenced to the
appropriate notebook number and page and vice versa. Additional
information, such as the project name/number, study name, device used to
collect data, date of collection, researcher’s name, etc, should also be included
where relevant.
e) Specify computer programs (not fully described in the study protocol or
method) used to perform calculations on raw data. Source codes are not
necessary, but indicate the nature of the calculations.
Records for patent purposes
The importance of keeping careful, accurate records of laboratory work, to prove inventorship and to assist
in preparing the patent specifications which, by law, must describe the invention, cannot be over-
emphasised. Dependence on memory or scanty notes for this purpose may result in an invalid patent.
Any record may serve as evidence to prove inventorship, but the laboratory notebook is the most
important.
a) Describe methods in detail or by reference to an approved protocol, standard operating procedure or
method of the date of a previous notebook entry at the beginning of the experiment.
b) Keep entries factual when reporting an experiment. Note and record unusual or interesting
observations during an experiment separately, under a heading of ‘Observations’. Premature or hasty
statements such as “an experiment was unsuccessful” should be avoided. If recording an idea to be
worked on later, be full in your discussion; use general language, state equivalents, etc.
c) Keep entries up-to-date. Advance attention to planning the experiment will give a clearer, more
intelligible record.
d) Make the entries complete, so that one skilled in the art would be able to repeat the work. The
procedure should be clearly stated in words or by reference.
e) Record the findings regarding a compound’s/cell line/molecule/other reagents etc activity in the
notebook at the end of each experiment. The result, clearly set forth, should be supported with
analytical data.
f) Do not describe an invention or name an inventor in the findings.
g) Enter a conception on a separate page in the notebook, or keep a conception notebook.
 Summary of General Guidance
• A laboratory notebook should be permanently bound and tamper evident with sequentially numbered
pages.
• Pages must never be removed or tampered with.
• A laboratory notebook is a legal document and must be handled accordingly.
• Entries should start at the top of each documentation page.
• Spaces, which are free of entries, must be crossed out.
• Do not start a new page until the previous page is full or has been marked so that no additional entries
can be made on it.
• Do not write outside the documentation area. If an entry will be continued on the next page, this should
be noted in the spaces provided.
• Entries must be made in ink, preferably archival ink. Never use pencils or any non-permanent writing
instrument.
• It is permitted to affix entries, such as raw data tables, folded graphs, or computer printouts to the
documentation pages in an appropriate, chronological location. This must be done so that the entry is
permanent. Initial both the affixed entry and the notebook page. The purpose of these supplemental
entries should be clearly described nearby. Never attempt to remove, obliterate, blot out or erase
entries. Before a page is signed and dated, you may correct an entry by marking with a single line
through the speci!c error and add your initials next to it. It is important that the error is still legible.
 Summary of General Guidance
• Every laboratory notebook page must be signed by the author and countersigned by at least one
corroborating witness. This witness should not be directly involved in the documented activities. The
witness confirms with their signature and the date that she/he understood the entries and that the
activities performed took place on a certain date.
• After a page is signed and dated, no further changes, interlineations, deletions, or additions are
permitted. If an entry must be corrected subsequently, use a new page and refer to it in your new entry.
• The person assigned the laboratory book is responsible for its content and safe keeping. Entries by a
third party are not permitted, with the exception of the witness when signing and dating a page.
• Immediately enter your work in a clear, concise, structured and legible manner. Entries should be
recorded with the intent of an independent person, who is skilled in the art, being able to comprehend
and reproduce your results.
• Record all experimental work, calculations, sketches, diagrams, and any other related information
directly into the notebook.
• Retain a consistent language, numbering system, and indication nomenclature throughout the
laboratory notebook in order to avoid confusion. Abbreviations must be defined and remain constant
throughout the entire book.
• Provide figures and equations with numbers or letters and refer to them within the description.
Closing out notebooks
Notebooks that are not used for frequent reference
should be returned to the supervising senior
researcher unless otherwise advised.
If a notebook is returned with unmarked pages, write
‘Notebook closed; no further entries’, following the
last recorded data. Date and sign the page.