Notebooks and Protocols

1. Notebooks and Protocols Records and Recipes

2. Documentation in the Lab

3. What Is Documentation? • Documentation is a system of records, essential to any quality system. • If a scientist can’t show evidence of their results, those results are not credible. • Biotech and pharmaceutical companies really care about documentation. • So do research labs.

4. Functions of Documentation • Record what an individual has done and observed. • Establish Ownership for patent purposes. • Tell workers how to perform particular tasks. • Establish the specifications by which to evaluate a process or product.

5. Functions of Documentation • Demonstrate that a procedure was performed correctly. • Record operating parameters of a lab instrument. • Demonstrate by an evidence trail that a product meets its requirements.

6. Functions of Documentation • Ensure traceability: track every component of the product and its origins. • Establish a contract between a company and its customers (certificate of analysis, label contents). • Establish a contract between a company and the regulatory agency (FDA).

7. Common Lab Documents • Laboratory Notebooks. • Standard Operating Procedures (SOPs). • Forms. • Protocols. • Reports. • Equipment/Instrument Logbooks. • Recordings from Instruments.

8. Common Lab Documents • Electronic documents. • Numbering systems (bar codes, lot numbers). • Chain of custody forms. • Training reports. • Labels.

9. Laboratory Notebook • A chronological record of an individual’s work- the primary document in a research laboratory.

10. Laboratory Notebook: Why Worry? • Intellectual Property for patents. • Recording what you did so you or others can repeat the experiments. Good records make it easier to publish your results. • Troubleshooting- careful notes help you find mistakes, bad materials etc.

11. Laboratory Notebook Rules • The notebook should have permanently bound pages which are consecutively numbered and should be used by a single engineer or scientist. • Ideas, calculations and experimental results should be entered into the notebook as soon as possible, preferably the same date they occur, so that the laboratory notebook becomes a daily record of the inventor's activities. Recopying can cause errors.

12. Laboratory Notebook Rules • All entries should be made in the notebook in permanent black ink and should be as legible and complete as possible. • Write legibly. • Draw a line through all errors and date the corrections. Do not erase. Never use whiteout.

13. Laboratory Notebook Rules • Notebook entries should be made without skipping pages or leaving empty spaces at the bottom of a page. • To start an entry on a new page, draw a line through any unused portion of the previous page. • Never tear out or remove a page from the notebook.

14. Laboratory Notebook Rules • Each page should be signed with the inventor's full name and dated. • All photos, charts or computer printouts pertinent to the project should be permanently put in the notebook with your initials and date over the tape. • No entry should be changed or added to after signature by a witness. • If the inventor has any additional information or corrections, a new entry should be made.

15. Laboratory Notebook Rules • If an additional entry is made between the initial and final pages recording an experiment, the entry should identify the page on which the previous entry for that experiment occurs. You can state: “Continued from Page 23.”

16. Laboratory Notebook Rules • Store the lab notebook in a safe location in the lab. Companies make microfilm copies. (Computer files don’t provide sufficient evidence of priority of invention.) • The old notebooks should stored following the company's record retention and destruction policy for such documents.

17. What Is an SOP? • Standard Operating Procedure: • A procedure that is done many times in many different protocols may have an SOP written. • For example, running the Autoclave may require an SOP. • Some labs have you fill out a form showing you performed the SOP every time you use a piece of equipment.

18. Reports • Lab reports summarize what experiment was done, who did it, why it was done and the conclusions of the study. • Lab reports are usually published in scientific journals after they are reviewed by other scientists.

19. What Is a Protocol? • A detailed plan of a scientific or medical experiment, treatment, or procedure. • A step-by-step outline that tells a scientist how to perform a task or perform and experiment that is intended to answer a question. • Next is a very short protocol:

20. Protocol for DNA Precipitation • http://iprotocol.mit.edu/protocol/64.htm

21. Protocols • Protocols are also called recipes. • Just like recipes, some are clear and some are fairly poor. • You will be called upon to follow, revise and write protocols often in laboratory classes.