Frequently Asked Questions About the Use of ELNs at NIH
Table of Contents
A. Implementation
- What is the federal mandate driving the transition to ELNs and how is does it apply to NIH IRP?
- Is NIH providing ELNs? What about outyear funding?
- What are the benefits of using an ELN?
- How is OIR managing the implementation of ELNs?
- Which IRP staff are responsible for developing Investigator-level ELN plans?
- Is an ELN required even if other digital systems are used to carry out the research?
- Do all members of an Investigator's group need an individual ELN?
- If a team member does not need an individual ELN, will they still need an ELN account?
- Why is NIH providing two ELNs?
B. Access
- What are the NIH-wide ELN options, when will they be available, and how do I request accounts?
- What are the resources for ELN training?
- Will ELNs be provided for Interns?
- What happens if LabArchives goes away?
- How is NIH handling WiFi dead spots in the scientific buildings?
- How can ELNs be used when there is no internet connection?
- How can ELNs be used in lab spaces where it is not possible to bring in a user's primary computer?
- How will the need for 2nd Devices be handled?
- Can I access an ELN on an iPad?
- How can I incorporate paper notes into an ELN?
C. Data Storage & Security
- How long is data stored in ELNs?
- Are ELNs secure?
- How should large data files like whole slide images be managed in ELNs?
- Do the NIH-provided commercial ELNs support the use of PII/PHI?
D. Alternatives to the NIH-provided Commercial ELNs
- Can Microsoft (MS) documents or OneNote notebooks be used as ELNs?
- My group wants to use the free Benchling ELN. Is this acceptable?
- Can electronic documentation systems already in use serve as an ELN?
- Can I use version control systems like Git with ELNs?
- Electronic documentation systems for math equations, including handwritten notes
E. Transition from Paper to Electronic Formats
- What will happen to existing paper notebooks?
- Can I transfer data from OneNote into one of the approved ELNs?
A. Implementation
A1. What is the federal mandate driving the transition to ELNs and how is does it apply to NIH IRP?
NARA/OMB M-19-21 / M-23-07 mandates that all Federal Records must transition to electronic format by June 30, 2024. The mandate applies to lab notebooks because they are Federal Records. No significant extensions or exemptions are expected. On January 3, 2024, Dr. Schor, DDIR, NIH, informed the NIH IC Scientific Directors that in practice, this means that no new paper laboratory notebooks should be created after June 30, 2024. Specifically:
- New research initiated after June 30, 2024 should be documented using approved electronic lab notebooks (ELNs).
- Ongoing research should be transitioned to approved ELNs by June 30, 2024.
- Final documentation of research expected to conclude by or shortly after June 30, 2024 may be completed using lab notebooks already in use.
- Legacy paper notebooks needed for scientific reference should continue to be managed in accordance with applicable records management requirements but do not need to be digitized.
A2. Is NIH providing ELNs? What about outyear funding?
YES. Lab notebooks are Federal Records owned by the NIH. Therefore, NIH has taken steps to ensure that we have fully funded ELNs which meet NIH ELN Requirements [NIH Only] in sufficient quantity to cover 100% of NIH's scientific staff by the June 30, 2024, deadline for the transition to electronic records. Moreover, DDIR, NIH, has indicated that she will serve as the Executive Sponsor on the ELN outyear funding request as she has done for the FY24 base year request.
A3. What are the benefits of using an ELN?
Benefits include but are not limited to:
- Enhanced data integrity for all use cases
- Streamlined linking of sample-level data to instrument data
- Uniform data templates and sample manifests for submission to core facilities
- In-platform data validation
- Enterprise-wide collaboration
- Widgets and templates that can be used to build longitudinal relational databases
- Integration with instruments, HPC, data systems
- 24/7 “PI Dashboard” view and control of ELNs
- Advanced searching across all ELNs
- Granular permissions - page & entry-level
- Support for pre-clinical studies, INDs, CRADAs
- Page locking, witnessing, time stamps, audit trails
- Master file linking to experiments
- Reagent tracking
- Scheduler for equipment, procedure rooms
- Rapid data sharing of unique data via DOIs
- Integration with other components of the data environment
A4. How is OIR managing the implementation of ELNs?
OIR has established an NIH ELN Implementation Team (NEIT) to collaborate on shared governance of the NIH-funded ELNs, manage IC-specific user needs, and advise on ELN-related issues in general. The NEIT is an extension of the multi-IC LabArchives pilot implementation team and includes IC representatives [NIH Only] designated by the IC SDs, including members of the NIH ELN Working Group; expertise is augmented by inclusion of IC ISOs and CIOs and other domain experts, as needed. The group is led by Janelle Cortner, OCIO, NCI; Anna Amar, DCM, OD, NIH; and Sam Michael, CIO, NCATS. NCI is managing the LabArchives contract and serving as the FedRAMP sponsor; NCATS is managing the Signals contract and serving as the FedRAMP sponsor.
A5. Which IRP staff are responsible for developing Investigator-level ELN plans?
Investigator-level ELN plans are required for staff who manage independent or targeted research budgets or who have been assigned data management responsibilities by their ICs. This includes three major categories of staff:
- NIH Principal Investigators (PIs) who receive resources to conduct independent research. This includes these DDIR/OIR-approved Intramural Professional Designations: Senior Investigator, Investigator, Senior Clinician, Senior Scientist, Assistant Clinical Investigator, and Independent Research Scholar.
- Non-PI IRP Lead Investigators who file annual reports and receive or manage funding targeted to the operation and management of technology-based research facilities and/or research support teams.
- Other group leads who have been assigned data management responsibilities by the IC SD and who are formally responsible for the conduct of the research activity but are not formally responsible for managing the associated budget.
A6. Is an ELN required even if other digital systems are used to carry out the research?
At NIH, a lab notebook is a Federal Record intended to serve as the complete research record, documenting why specific experiments were initiated, how they were performed, what data and observations were produced, where the data are stored, and how the data were analyzed and interpreted, in sufficient detail so the research can be reproduced by others 1, 2. In practice this means that a scientifically literate person with no prior knowledge of the project should be able to use the documentation provided in the notebook to navigate the rationale, methods, experimental samples, results, analysis, and basis for the major conclusions entirely from the ELN. This “reproducibility standard” applies to traditional paper lab notebooks, ELNs, or other comprehensive electronic research documentation systems the Investigator may use instead of a commercial ELN. Generally, the use of specialized digital systems to generate, store, and analyze data does not replace the need for an ELN to serve as the central documentation hub to tie together the experimental design and sample-level details with the resulting data and analyses in a manner that enables the research to be reproduced, except in special circumstances. Use of a specialized digital systems other than ELN software approved for NIH-wide use can serve in this role if used in a manner that meets the reproducibility standard for documenting the complete research record and if the system meets IT System Requirements for ELNs [NIH Only]. Major research domains where specialized documentation systems are in widespread use which may be suitable ELN alternatives include but are not limited to clinical trials research, epidemiology, computational biology, and engineering.
- Many computational biologists, epidemiologists, and bioinformaticists use resources such as Jupyter notebooks and GitHub to document their research. Depending on the scope of the research, these resources can sometimes meet the reproducibility standard and therefore replace the need for a separate ELN, if run in a compliant environment. Alternatively, the Investigator can use these resources in conjunction with an ELN to capture the additional detail needed to meet the reproducibility standard. NIH currently hosts its own GitHub instance, and NCATS hosts Jupyter notebooks in a compliant environment which could be made available to users NIH-wide. Given the significant demand for such alternatives, NEIT is working with stakeholders to develop possible approaches for leveraging these resources for discipline specific ELN use.
- ICs typically require use of specialized electronic documentation systems for clinical trials and other types of clinical activities such as clinical care. IC Clinical Directors are best positioned to determine which of these systems can be used in a manner that documents the complete research record and when an additional system may be required. For example, the IC's clinical trials system may be sufficient to document the complete research record for clinical trials but not for clinical research involving secondary reuse of human specimens and data derived from those clinical trials for extension studies not covered under the trial design. Application of the reproducibility standard will assist Investigators in determining whether an ELN is needed. Many times, something as simple as an Microsoft (MS) Word document is all that is needed to fill the gap.
Regardless of whether an NIH-wide ELN or an alternative documentation system approved by the IC is used, the Investigator is responsible for assuring that the research is properly documented and that the resulting records are managed in accordance with federal requirements, including maintaining an up-to-date lab notebook list on the Investigator's Index Record of Retrievable Data Sources. All Investigators are encouraged to review the Investigator Responsibilities for ELN Management and NIH IT System Requirements for ELNs to assure compliance with records management and security requirements.
A7. Do all members of an Investigator's group need an individual ELN?
No! Multiple scenarios are possible, depending on the way an Investigator's research is structured:
- Investigators may choose to assign ELNs to individual group members in cases where group members work on relatively independent projects.
- If an Investigator's research is highly collaborative, it may be preferable for multiple team members to work in project-focused ELNs, or to use mix of individual and project-based ELNs.
- If many team members have highly focused research roles and their work is entirely documented in, for example, a GitHub repository or Jupyter notebooks, it is possible that no ELNs would be required, or only the Investigator would need an ELN to document the complete research record, which they would do in part with links to the analytic outputs of the resources used by their team members.
Regardless of the model used, all the ELNs and ancillary data systems required to document an Investigator's research record are the responsibility of the Investigator, and s/he must therefore be designated within the IT systems as the “Owner" of the ELNs and ancillary resources, such as GitHub repos and Jupyter notebooks. For commercial ELNs, this is done via role-based permissions; for document-based ELNs, this is accomplished by storing the ELN on a Teams or SharePoint site “owned” by the Investigator.
A8. If a team member does not need an individual ELN, will they still need an ELN account?
While not every member of an Investigator's team may require an individual ELN, most will still require an ELN account, if ELNs are used by some group members. For example, scientific staff who primarily carry out a single research role and use specialized systems to document their work (e.g., performing biostatical analysis) may not require their own ELN. However, if they need access to other ELNs used by the group (e.g., to access experimental design details or raw data) then they will need an ELN account. Similarly, team members who provide research support, such as preparing reagents or specimens for use by others, will likely need access to at least some of the ELNs in use by the group to carry out their work efficiently and therefore will require ELN accounts. Note that the very granular permissions available in commercial ELNs can be used to limit access to specific sections of notebooks and even to specific entries.
A9. Why is NIH providing two ELNs?
Although there is no single, universal ELN that will meet the needs of all users across the range of disciplines pursued within the NIH, coalescing around a small number of versatile platforms has the potential to streamline collaboration and data sharing, accelerate research, drive platform interoperability, and enhance operational efficiency. For these reasons, NIH is making one multi-discipline ELN (LabArchives) and one chemistry-specific ELN (Signals) available for NIH-wide use. Additionally, because many ICs use electronic systems specific to their areas of research, we anticipate that some ICs will approve use of some IC-provided systems.
B. Access
B1. What are the NIH-wide ELN options, when will they be available, and how do I request accounts?
It is expected that three Platforms Currently Available for Use NIH-Wide will be available by June 30, 2024, including LabArchives and Signals, which are both available now. Additionally, MS documents such as Word or Excel may be used in cases where research is not expected to produce IP. Finally, Investigators who require use of specialized systems to document their research should work through their Chief Information Officers (CIOs) to obtain approval for use of IC-provided resources.
LabArchives multi-discipline ELN
- LabArchives is available to Investigators at all ICs now. View and request invitations to live training sessions at LabArchives Support and Onboarding [NIH Only].
- LabArchives is appropriate for documenting research expected to generate IP and for use in validated GxP environments.
- Investigators requiring enhanced chemistry capabilities but who are not directly engaged in medicinal or synthetic chemistry should consider using the LabArchives ELN with ChemDraw.
- All NIH Investigators (or their designees) can request LabArchives accounts for their group members using this link:
- LabArchives Support and Onboarding [NIH Only]
- Information about LabArchives ELN users can be found here: LabArchives Overview; additional documentation is available in the LabArchives Knowledge base. Users may also wish to read about the inventory and scheduling modules or watch tutorials on the LabArchives YouTube channel.
Revvity Signals chemistry ELN
- Chemistry groups requiring Signals were identified as part of the Investigator ELP Planning Survey conducted in February-April, 2024. Any additional groups can be added via their ELN Implementation Team IC representatives.
- Signals onboarding is a customized process that depends on the group’s specific needs and workflows and is supported by Revvity. Training is covered as part of the onboarding process.
- Signals is appropriate for documenting research expected to generate intellectual property (IP) and for use in validated GxP environments.
- Signals is especially well-suited for synthetic and medicinal chemistry; investigators working in these areas will be prioritized for access to the planned 1,000 licenses.
IC-provided Resources
In addition to resources approved for NIH-wide use, IC-provided resources for specialized applications such as clinical trials, clinical care, biostatistics, engineering, and other uses can be approved for use under certain circumstances. Investigators should work through their IC CIO to learn more about IC-provided options. Note that software used for ELNs must be able to support the same records management requirements as paper lab notebooks and commercial ELNs and meet the same security requirements as other software used at NIH. All applicable requirements that should be considered when selecting ELN software are summarized in the NIH ELN Requirements. Selecting commercial software that has been approved by NIH or the Investigator’s IC for use as an ELN can greatly simplify the process of assuring compliance with applicable requirements and is encouraged whenever possible. Investigators are discouraged from using free ELN accounts or purchasing ELN software without IC approval.
B2. What are the resources for ELN training?
Platform-specific training for LabArchives and Signals is scheduled for new users when accounts are requested. Scientific staff are additionally encouraged to view the OITE Webinar on Lab Notebook Best Practices [NIH Only]. Although the current version is 12 years old, it applies equally well to both paper and electronic formats and sets a common baseline for lab notebook usage at NIH that aligns with the principles covered in the CoR. This link will be updated with OITE's new version geared specifically toward ELNs soon.
B3. Will ELNs be provided for Interns?
YES. Interns will be provided accounts in the NIH-provided ELN options.
- Interns can use MS documents, if used in accordance with guidelines and approved by their IC.
- Interns working with the chemistry groups will be provided Signals access; this will be addressed at the time of onboarding.
- NIH LabArchives users have unlimited free “guest” seats for use by interns for up to 60 days.
- LabArchives users can request intern accounts using the LabArchives Support and Onboarding [NIH Only] ticket. Additionally, interns will be invited to a live training session for scheduled for June 3, and provided with a self-directed “quick start “video, and can attend LabArchives office hours for technical assistance.
- The small subset of Interns requiring longer durations can be seamlessly moved into regular “user” seats by the labs; impact to cost is minimal for a few weeks of additional access.
- When continued collaboration is needed after Interns return to their home institutions, they can be enabled as outside collaborators, also at no additional cost (we have 1,400 no cost user seats for outside collaborators.)
B4. What happens if LabArchives goes away?
LabArchives was selected based in part on its track record for providing resources to institutions comparable in size to NIH and longevity of the company. They have committed significant resources to achieve FedRAMP certification, further cementing their commitment to support Federal research labs, so we do not anticipate that LabArchives will cease to be an ELN option. If our contract were to end or if data needs to be transferred out of LabArchives for other reasons, the data are contractually required to come out in the original input formats and hierarchical organization used to create the ELN. Exports of the daily ELN entries are available in PDFs or HTML and render nicely following export.
B5. How is NIH handling WiFi dead spots in the scientific buildings?
CIT is currently implementing a multi-year plan for upgrading NIH's network, which is anticipated to eliminate or significantly reduce WiFi dead spots (Updated CIT Schedule [NIH Only]. Users are encouraged to submit a ticket to CIT to request additional LAN jacks for wired connections while awaiting network upgrades. Alternatively, GFI can be used to create temporary hotspots to support ELN usage.
B6. How can ELNs be used when there is no internet connection?
As noted in the Conduct of Research in the Intramural Program at NIH, “Researchers sometimes face situations in which bringing a laptop or other electronic device into an area is not practical or safe, or some data cannot be recorded efficiently using an electronic device. In these cases, non-digital data must be converted as quickly as possible into digital data to serve as the official record. Hand-written data must be transcribed and/or digitally scanned or photographed and uploaded.” Approaches for capturing paper-only data sources are described in Section IV of the policy, Investigator Responsibilities for ELN Management. In brief, documents can be scanned to generate pdf files or photographed to create image files which can then added as attachments to the ELN using compliant approaches. Notably, LabArchives has an in-platform camera app that can be accessed from browsers on either GFE or POE and used to capture images directly to LabArchives, without retention of the image on the device.
B7. How can ELNs be used in lab spaces where it is not possible to bring in a user's primary computer?
If there is an internet connection a secondary device can be provided for dedicated use, for example:
- Tablets that can support multiple users can be provided in containment workstations.
- Tablets or iPads for individual users can be kept in the lab at their primary workstation.
- When working in lab spaces without internet connectivity or if no device is available for accessing the ELN, users can print out paper copies of any needed protocols for use, take paper notes, and then photograph and save a copy of any handwritten notes to the ELN. In such cases, the digital copy added to the ELN documents the research record and the paper copy can be discarded. Additionally, the handwritten notes can be converted to searchable formats and searchable metadata tags can be added to the photo.
B8. How will the need for 2nd Devices be handled?
Some lab workstations preclude bringing in a user's primary laptop for ELN use for safety reasons. In these cases, additional devices for ELN use [NIH Only] that can be left in the lab are required. Windows devices support log-in by multiple users and are recommended for dedicated use at shared workstations. Many users select MS Surface Pro, because it is a lightweight yet powerful PC similar in size to an iPad with a rear-facing camera that can be shared by multiple users. Users may also want to consider iPads, but these do not support log-in by multiple users, requiring provision of individual devices for every user. Currently, ICs are expected to manage the provision of second devices as part of their overall program to provide government-furnished computers to their scientific staff.
B9. Can I access ELNs on an iPad?
LabArchives can be accessed from any device with a web browser. When considering which type of device to use, the choice largely depends on how the user wants to perform their work. Please refer to Using Mobile Devices with LabArchives [NIH Only] for an overview of hardware options for using LabArchives.
B10. How can I incorporate paper notes into an ELN?
See Section A of Investigator Responsibilities for ELN Management. In brief, you can scan paper-only data sources or take photos of them and add the files as attachments. If using POE phones, be sure to use the in-ELN camera app so the photo is not retained on your phone.
C. Data Storage and Security
C1. How long is data stored in ELNs?
Data stored in the NIH-provided commercial SaaS platforms are under the full control of NIH and will not be deleted by the vendor. Data are managed as a federal record. This means ELNs in active use for data collection or needed for scientific reference are retained indefinitely. Once an ELN is no longer needed by the Investigator it will be transferred to archival storage and kept for the appropriate retention period. Once in archival storage the same records retention considerations apply to ELNs as to paper lab notebooks, typically 7 years for most NIH research projects.
C2. Are ELNs secure?
YES, see section 2, IT System Requirements for ELNs. Security standards for ELNs are based on Federal-wide standards for electronic data systems and NIH-required controls for assuring data integrity. Both of NIH's commercial ELNs are SaaS products adhering to FISMA moderate standards and are on track for FedRAMP certification.
C3. How should large data files, like whole slide images, be managed in ELNs?
The ELN does not need to house all of your data. Many ICs have defined storage platforms for specific big data types like genomic data and imaging data such as whole slide imaging, radiology medical imaging, and advanced microscopy modalities. Users should document where the data are stored and bring in the file path, and summaries, thumbnails, and downstream analysis visualizations as needed.
C4. Do the NIH-provided commercial ELNs support the use of PII/PHI?
NIH's approved commercial SaaS platforms adhere to FISMA moderate standards and are therefore suitable for PII, including conditionally sensitive PII or PHI such as MRNs, date of birth, or image accession numbers which are frequently required for translational research. Investigators are encouraged to limit their use of conditionally sensitive PII or PHI to only the data elements required for their specific applications (e.g., use age instead of birthday when possible).
D. Alternatives to the NIH-provided Commercial ELNs
D1. Can MS documents or OneNote notebooks be used as ELNs?
Based on CIT's feasibility assessment, OIR has advised that NIH will follow CIT's guidance on use of OneNote and MS document based ELNs until further notice. This means:
- OneNote notebooks should not be used for ELNs of any type, including general purpose ELNs or ELNs documenting projects that are anticipated to produce IP. This is because OneNote lacks immutable versioning and does not support validated signatures.
- MS documents such as Word and Excel should not be used to create ELNs for the documentation of projects anticipated to produce IP. This is because NIH's MS environment does not support validated signatures.
- Investigators may plan to use MS documents for general purpose ELNs stored in NIH's MS environment (i.e. on a SharePoint, Teams, or OneDrive site that is owned by the Investigator) with the understanding that older versions will continue to be automatically deleted without the users' awareness until CIT has implemented the MS Records Management Module and the ELN Owner has taken steps to designate the ELN as a Federal Record.
- For this reason, Investigators may wish to delay use of MS document ELNs until the RM module is on.
- CIT has advised that RM module activation is expected to take place before the June 30 transition to electronic records deadline, although delays may occur.
- In addition to assuring that automated deletion of older versions is prevented, storage of MS document ELNs within NIH's MS environment on a SharePoint, Teams, or OneDrive site assures that the ELN always remains under control of the Investigator, allows the ELN to be marked as a Federal record using the Records Management module, and assures that the security parameters enabled by the MS FedRAMP compliant ATO apply to the ELN. Storage platforms that do not clearly designate the Investigator as the Owner of the stored documents or are outside of the NIH MS environment are not acceptable for storing ELNs. For example, BOX is not a suitable storage option because any ELNs stored in BOX would not have an in-platform Federal records designation or the associated version control mechanism, nor would the ELNs be secured with multi-factor authentication.
- Investigators wishing to pursue an approach for IC management of OneNote ELNs should work through their IC CIOs to prepare an exemption request and written proposal detailing the management procedures and controls that will be used by the IC to meet the NIH ELN requirements and mitigate the risks.
- Proposals should be submitted to the NIH ELN Implementation Team (NEIT) for evaluation by a technical group that will include CIT and other appropriate domain experts.
- Given that meeting NIH ELN requirements is expected to be cumbersome and resource intensive, ICs are urged to weight the feasibility implementing any such proposals against the perceived benefits of using OneNote rather than using the NIH-funded commercial ELNs or other compliant IC-provided ELNs that may be available before requesting a technical evaluation.
D2. My group wants to use the free Benchling ELN. Is this acceptable?
Many molecular biologists like the free version of Benchling and therefore extensive efforts were made to develop an acceptable approach for the use of Benchling at NIH. One of the biggest problems with Benchling is that the free version does not provide enterprise ownership of ELNs, which is an absolute requirement. There is an enterprise version of Benchling, but it provides extensive capabilities that are not compatible with use of NIH's many legacy data systems and data models. Moreover, depending on the modules selected, Enterprise Benchling can easily cost 10X as much per user as other similar ELNs. Another problem is that Benchling does not meet Federal security requirements and the vendor has not expressed interest in working with us toward that goal. This may be because big pharma is the primary market niche for enterprise Benchling. Because the platform is considered to be highly secure, it is possible that NIH-wide Authority to Operate could be achieved without significant cooperation from Benchling, although this would be labor-intensive and would not address the bigger concerns of cost and incompatibility with legacy systems. For these reasons, Benchling is not currently an approved option. Fortunately, and we do not foresee any use cases that cannot be adequately handled in LabArchives or Signals, and migration of Benchling ELNs into LabArchives is not particularly difficult, assuming the Benchling ELNs are well structured. We will continue to have periodic discussions with Benchling with the goal of adding it as an acceptable option in the future.
D3. Can electronic documentation systems already in use serve as an ELN?
Sometimes. Use of a specialized digital systems other than ELN software approved for NIH-wide use can serve in this role if used in a manner that meets the reproducibility standard for documenting the complete research record and if the system meets IT System Requirements for ELNs. Major research domains where specialized documentation systems are in widespread use which may be suitable ELN alternatives include but are not limited to clinical trials research, epidemiology, computational biology, and engineering.
- Computational Science: Many computational biologists, epidemiologists, and bioinformaticists use resources such as Jupyter notebooks and GitHub to document their research. Depending on the scope of the research, these resources can sometimes meet the reproducibility standard and therefore replace the need for a separate ELN, if run in a compliant environment. Alternatively, the Investigator can use these resources in conjunction with an ELN to capture the additional detail needed to meet the reproducibility standard. NIH currently hosts its own GitHub instance, and NCATS hosts Jupyter notebooks in a compliant environment which can be made available to users NIH-wide. Given the significant demand for such alternatives, NEIT is working with stakeholders to develop approaches for leveraging these resources for discipline specific ELN use.
- Clinical Research: ICs typically require use of specialized electronic documentation systems for clinical trials and other types of clinical activities such as clinical care. IC Clinical Directors are best positioned to determine in consultation with their Investigators which of these systems can be used in a manner that documents the complete research record and when an additional system may be required. For example, the IC's clinical trials system may be sufficient to document the complete research record for clinical trials but not for documenting secondary objectives that are not covered in the clinical trial documentation. Application of the reproducibility standard will assist Investigators in determining whether an ELN is needed. Many times, something as simple as an MS Word document is all that is needed to fill the gap.
D4. Can I use version control systems like GitHub with ELNs?
Yes. GitHub is a FedRAMP certified Microsoft product and NIH has its own GitHub repo. GitHub is well suited for storing versions of analytic code and notebooks such as Jupyter notebooks, which also have FedRAMP certification and are well suited for documenting the complete research record. In the coming weeks NEIT will work with computational scientists to prepare basic guidance for use of compliant resources such as Jupyter notebooks and GitHub for use as ELNs.
D5. Electronic documentation systems for math equations, including handwritten notes.
Approaches vary depending on how the data are initially created, where the equations will subsequently be used, and which documentation system will be used. Please see how to work with handwritten content [NIH Only] for a more complete discussion of input approaches. Briefly:
- Keyboard Text Inputs: There are several options for creating math text via keyboard data entry. LabArchives and Signals both provide math text input capabilities directly into the ELN. Alternatively, software such as Latex can be used to write math equations using a standard keyboard. The electronic files thus produced are then uploaded to ELNs or other documentation systems such as Jupyter notebooks that support downstream use as well as documentation.
- Conversion to Text From Handwritten Stylus Inputs: Several approaches for creating math text from stylus inputs exist. Currently neither LabArchives nor Signals supports direct entry of stylus handwriting into the ELN, but OneNote and Adobe are two such resources available to NIH users. Once created, the electronic files are then transferred to an appropriate documentation system.
- Conversion From Images of Handwritten Notes: There are a few programs available that can convert images of handwritten equations to text, but NEIT has not evaluated them yet. ICs with users who have knowledge in this area are invited to share their findings with NEIT for inclusion in the list of resources.
E. Transition from Paper to Electronic Formats
E1. What will happen to existing paper notebooks?
- Active: If you are still putting results into the notebook for an ongoing project, you have until December 31, 2024, to complete that notebook, but you may not start a new one after June 30, 2024.
- Reference: For notebooks that are complete, but still needed for reference, NIH has requested from the National Archives and Records Administration (NARA) a permanent exception to the policy for NIH to be able to maintain, in original paper format, without the need to scan/digitize, all notebooks needed for reference. Notebooks can also be held at designated Records Holding Areas (RHAs) within appropriate ICs, and easily recalled, with an understanding that all records will be managed in accordance with NARA requirements.
- Ready to Archive: The exemption also applies to notebooks ready for archiving, they do not need to be digitized if archived now through June 30, 2024. To take advantage of storing paper notebooks in a Federal Records Center (FRC) you would need to work with your IC's Records Liaison to prepare a transfer request for submission. In addition to space savings, transferring the notebooks to a FRC mitigates risk to the NIH enterprise by placing the burden of safe and secure storage and maintenance on the facility, not NIH space.
- Create a PDF of the OneNote notebook and upload the PDF to the new platform.
E2. Can I transfer data from OneNote into one of the approved ELNs?
LabArchives and Signals both support MS Word documents although there is no direct way to transfer data from OneNote to the approved ELNs, there are a variety of options:
- Copy the most relevant content from the OneNote notebook and then paste it into the new platform. (Please note that some of the formatting will not transfer perfectly.)
- Do not transfer any data from the OneNote notebook and start “fresh” in the new platforms but add a reference link/filepath to the existing file for continuity.
1 Conduct of Research in the Intramural Program at NIH, 8th Edition, 2023
2 NIH OITE Webinar, Keeping a Lab Notebook: Basic Principles and Best Practices (October 21, 2023) [NIH Only]
This page was last updated on Tuesday, July 9, 2024