A proper laboratory notebook can be crucial to demonstrating ownership of
IP, or adherence to government regulations, whether you are preparing patent applications, legal records, or reporting drug research under FDA guidelines. Unfortunately, we often get caught up in the practical work and forget the lessons about proper record-keeping that we were all taught in our undergraduate laboratory classes. The following is a quick refresher for anyone who has let their record-keeping style "slip" a little.
1. Start with a Bound Notebook
Proper record-keeping begins in a laboratory notebook bound with glue. Loose-leaf papers in a binder, or spiral-bound notebooks are unacceptable.
2. Write in Blue or Black Permanent Ink
The idea here is that all entries are non-erasable (i.e. no pencils allowed) and can be photocopied if required.
3. Enter Records Immediately
Entries should always be written at the time the research occurred. This ensures that procedures, data, and observations are written accurately, as they occur, and prevents the introduction of error due to memory lapse.
4. Sign and Date All Entries
Remember that the notebook can be used in court as a legal record, should disputes of IP ownership of arise. It is a chronological record of all research. Therefore, all entries must be dated. The bottom of each page must be signed by the researcher.
5. Use Numbered Pages
Mistakes can be crossed out with a single line through them but one must never remove pages from the notebook. It is important to use a book with consecutively numbered pages, and that these pages remain intact. Each experiment should begin a new page, and large blank areas crossed out with an "X".
6. Use a Table of Contents
A table of contents at the front of the notebook will aid in finding relevant data and demonstrating the chronological order of experiments. If an entry is made for a previously completed experiment, or between the first and final pages of an experiment, out of chronological order, refer to the page number on which the previous entry for that experiment occurs.
7. Write Legibly in Detail
Always assume someone else will want to follow your work and write all entries in a legible fashion with enough detail that the experiment could be repeated in your absence. In the biotech industry, a lot of techniques require the use of pre-made commercially available kits and solutions. Clear reference to the source of these tools is sufficient, without detailing solution ingredients and preparation. Remember to label all figures and calculations.
8. One Book, One Investigator
Each laboratory notebook should be used by only a single scientist or engineer, to ensure accuracy, organization and completeness.
9. Witnessed Entries
A second researcher, who is familiar with the project and understands the work, but is not directly involved, should witness all entries with a signature and date. Witness signatures should be entered close to the date of the original entry (within a week is acceptable).
10. Store Completed Notebooks
Index and store all completed notebooks in a safe, secure place.
