Barry Bunin, PhD, CEO of Collaborative Drug Discovery explores the rise of electronic lab notebooks and why researchers should be transitioning to digital methods of recording data.
The laboratory notebook has been around for centuries. Scientific breakthroughs from the 18th Century through to today have at one point been recorded by hand in such a notebook. However, while nostalgia is great, it is not the best way to do high-quality science. Today, we have better tools for tracking research and better tools to (re)-use our past results.
One massive problem facing today’s science is reproducibility. When experiments are not reproducible, everyone suffers – from wasting time pursuing a result that was not real to creating products that end up not working. It’s a huge and important issue. Multiple factors feed into the reproducibility crisis, but correctly recording and documenting experimental procedures and results is key to improving reproducibility.
While the paper laboratory notebook has been around since the dawn of scientific study, this does not mean that we should just keep using it. The technical advancements of the past 50 years or so have increased the complexity of research experiments tremendously. The methods that we use to record, store, and share our data need to match these technical advancements.
In today’s world, the majority of research data capture, analysis, and results are performed and presented in a digital format. Having to transcribe your digital data onto the written page and then back into a digital format for publishing is unnecessary, time-consuming, and prone to errors.
The Electronic Lab Notebook (ELN)
Scientists work in labs where lab equipment is controlled by computers for data acquisition and analysis. There is a need for secure and reliable documentation of both the data and protocols (also sometimes referred to as metadata). Leading companies and academic labs have embraced the digital paradigm. Science has always been data-driven. Today, it is driven by much more data than in the past.
Electronic Lab Notebooks (ELN) first emerged in the late 1990s and have gone on to become more widely used in both research and commercial labs today. Whilst digital platforms have streamlined and optimised much of today’s scientific research and development, lab notes themselves were one of the last research processes to receive modernisation.
ELNs were designed to enable scientists to enter, store, and share their data as appropriate. For scientific research, they’re used to provide teams with greater security, accuracy and reproducibility of their work.
The question as to whether ELNs can replace manual note taking should be rather obvious. By not creating digital records of data, scientists risk losing vital information, leading to delays and setbacks in research. With an ELN, experimental data becomes searchable and results can be found through the press of a button.
The ELN platforms record procedures and data much more reliably and thoroughly than is possible with traditional notebook entries. All changes are stored in the software and because the raw data can be stored alongside the analysed results – it’s simple to see how a conclusion was drawn.
In today’s world, the majority of research data capture, analysis, and results are performed and presented in a digital format. Having to transcribe your digital data onto the written page and then back into a digital format for publishing is unnecessary, time-consuming, and prone to errors. If you want your research to move forward at the rapid pace of science in the digital era, using an ELN is non-negotiable.
But how do they work?
Using an electronic laboratory notebook can be nearly as easy as using popular word documentation software. Digital software programs have made the move to digital notebook an easy transition with a much lower learning curve than in the past.
In the same way as using a traditional notebook, ELNs allow notes to be entered or imported through a centralised computer system and users can access their ELN from any internet-connected device.
With online notebook systems, users can simply try the system to see how easily it will work. ELNs allow for seamless importing and exporting documents and spreadsheets. More specialised scientific ELNs can analyse specialised lab data types like chemical structures, biological sequences, dose-response curves, annotations, and controlled vocabularies.
ELNs also provide formatting capabilities and the ability to easily organise documents. Moreso, by making an ELN collaborative, researchers are able to either keep content private or selectively share with an entire team.
Digital notebooks featured within an ELN can incorporate and organise graphs, images, tables, and annotations. Users can create standard operating procedures (SOPs) and templates in a bid to assist with reproducibility. Available features of an ELN ideally can be accessed through a user interface within a software platform that is nearly as easy to use as familiar office-based or online document sharing packages.
Currently, many researchers use online databases like Dropbox or Google Drive integration to share and store their data. While this is convenient, it does not provide the same level of access control as an ELN. An ELN platform provides a secure software that can house both your research data and corresponding protocols on the electronic record.
The FDA has now switched to encouraging organisations to submit completely electronic documents, as traditional methods are becoming obsolete. In 1997, the FDA deemed that electronic records would hold up legally in the same way as handwritten records – opening up the gates for the adoption of electronic research notebooks.
The FDA has now implemented even more stringent guidelines for the ELN to ensure the security of data research.
In what is commonly referred to as 21CFR11 and GxP, the FDA upped the standards that medical and pharmaceutical companies have to meet to rigorously document their processes for using digital data security.
Typically documented functionality includes processes using electronic signatures, audit trails, modification tracking, and thorough standard operating procedures (SOPs) throughout the organisation. These requirements are more important at the later stages of drug discovery and development, the closer you get to an Investigational New Drug (IND) filing.
Rigorously documenting your processes using an ELN will help your organisation stay compliant, maintain data integrity, and data security.
Good Laboratory Practices
Regulatory compliance is crucial for organisations in many healthcare data-related industries. Good Laboratory Practices (GLP) guidance has been established for data security and storage that applies to ELNs.
When researching an ELN, organisation should do an assessment of the security measures for data security and storage. Companies should get clear assurance that their data is protected from hackers and should aim to get tracking for edits to ensure integrity.
Restrictions should be able to be customised and there should be a secure method to share, export, or migrate data. Anyone on a team, or other collaborators, may have the key discovery and data that provides the foundation for composition of matter and/or utility patents.
Remember that digital lab notebooks should provide procedures for exporting and reliability for access and sharing. This will include information on data protection and online backup data storage scheduling.
GLP compliance includes ensuring confidentiality through user agreements as well as through encryption and authentication protocols with electronic signatures across all levels of a team.
An ELN can meet strict adherence to GLP best practices – including processes outlined in the FDA 21 CFT Part 11 and ISO certification. The right software can give an organisation clarity, data backup, tracking, and clear data paths.
There are clear benefits of moving to an ELN. Benefits include improved data documentation, secure and shareable stored data, comprehensive workflow support, role assignments, import/export features, and greater reproducibility. These benefits directly translate to time and money saving.
The modern process for research and development is digital. Scientists consume and produce data digitally far more than through paper. It is not possible to excel in a digital world while still using a paper-based notebook to store and record data. Moving to a paperless lab environment is an inevitable trend of the modern scientific process.
Volume 23 – Issue 4, Fall 2022
About the author
Barry Bunin founded Collaborative Drug Discovery in 2004 to commercialise CDD Vault, a hosted platform that enables drug discovery scientists to securely organise, analyse, and share biological and chemical data. Dr Bunin was an Entrepreneur in Residence with Eli Lilly & Co. and obtained his PhD in chemistry from UC Berkeley.