|

OTT
Home
About OTT
Inventors
Industry
Technologies
News
& Events
Directions
ECU Main
Research
Colleges
& Schools
Health
& Medicine
Office
of Sponsored
Programs
|
Good Laboratory
Records & Documentation
Authenticity
and reliability are the key components of recognition
for both traditional and electronic laboratory
notebooks in a court of law. Good record keeping
is important for defending patents as well as scientific
misconduct.
Entry Recording
-
All laboratory information
should be recorded with indelible ink in a bound
notebook. The information should include the
hypothesis, materials and methods, data and
conclusions.
-
Every page should be pre-numbered
and used.
-
Do not leave blank spaces,
erase information or remove pages when adding
or deleting information. Instead, draw a line
through the information, provide an explanation
for the change and sign and date the change.
-
Charts, labels or any other
materials that need to be included, must be
permanently glued into your notebook.
-
Large quantities of computer-generated
data should be bound and witnessed on every
page.
Witness Corroboration
-
The person who worked on
and recorded the experiments in the notebook
must sign every page in the notebook: “Recorded
by me” (signature) and the date.
-
A witness who is technically
competent (principal investigator, colleague
or graduate student) but did not work on or
was unconnected with the research project. The
witness should be knowledgeable about the project
and should corroborate the entries by reading,
co-signing and dating all entries.
-
Corroboration should be completed
at least once every two weeks. Many labs host
periodic “Notebook Witnessing Days”
in order to keep their records up to date
Use, Supervision, and Retention
of Lab Notebooks
-
All laboratory notebooks
should be numbered in consecutive order and/or
under each scientist’s name.
-
The principal investigator
or laboratory director should supervise each
technician or graduate student with notebook
entries.
-
Electronic Laboratory Notebooks: Pros, Cons, and
Recommendations
The courts have not
fully addressed legality of electronic records;
however, acceptable practices at many organizations
include:
-
Print electronic data on a regular
basis.
-
Every page intended as evidence,
must be signed, dated, and witnessed in the
same manner as traditional laboratory notebooks.
-
Alternatively, data may be stored
in an optical format (Write Once, Read Many
or WORM). Although this may be more reliable
than other electronic notebooks, it does not
remove the witnessing requirements.

|
|