October 22, 2024
SHORT DESCRIPTION:
Digital Research Operations' Enterprise Research Applications team (Digital ERA) has an enterprise license for LabArchives for all researchers to use at no cost. LabArchives is a web-based application designed for scientists to organize and share laboratory data with their study team, department, across Mass General Brigham institutions and with external collaborators. Access rights are controlled by the notebook owner and can be modified to suit the individual needs of each researcher, educator, or contributor. Note: the PI must be set as owner. Other lab members may have different roles.
HOW TO INITIATE THIS SERVICE:
Simply Login to LabArchives w/Your Mass General Brigham Username
MORE INFORMATION:
Since October 1, 2016: Digital Research Operations' Enterprise Research Applications team (Digital ERA), manages an enterprise license for LabArchives for all researchers to use at no cost. LabArchives is a web-based application designed for organizing, documenting, and sharing research data with teams, departments, and collaborators. It includes tools for document collaboration, data input forms (called widgets), inventory management, and resource scheduling.
Click here to create your LabArchives account.
Mass General Brigham Electronic Lab Notebook (ELN) Policy
PIs must use an ELN (e.g., LabArchives) to document Research Data and other record keeping activities for active research projects as of their hospital’s ELN implementation date (Oct. 1, 2019 for BWH and MGH; Jan. 1, 2020 for MCL, MEE, SRH and IHP).
Mass General Brigham has licensed and provides support for LabArchives ELN for researchers to meet these requirements. PIs are required to establish a LabArchives account in their name and create notebooks and designate notebook access for their research staff. PIs must be set as notebook owner for all notebooks used in their lab.
FAQs:
Why is an ELN required?
LabArchives is part of a larger Mass General Brigham Research Data Management Integrity initiative (on the Research Navigator) that was launched in February 2018 to enhance Research Data integrity. The Mass General Brigham Electronic Lab Notebook (ELN) Policy (available internally on Archer) is effective as of May 1, 2019: PIs must use an ELN (e.g., LabArchives) to document Research Data and other record keeping activities for active research projects.
Policy Statement: Principal Investigators (PI) of Mass General Brigham (MGB) active research projects must transition from basic data documentation and management methods, e.g., use of MS Word, Excel without controls for auditing and tracking changes, paper laboratory notebooks, and paper processes, to digital technologies/electronic systems, i.e., Electronic Lab Notebooks or Research Notebooks (ELN), in accordance with the implementation schedule. Transition to electronic systems is required to meet regulatory and institutional compliance requirements, mitigate security risks, maintain data integrity, and protect intellectual property.
This Policy does not apply to:
- Clinical research projects that utilize electronic lab or data management systems, processes, and ELNs that are 21 CFR Part 11 compliant, or
- Sponsor-initiated clinical trials that utilize sponsor systems and processes.
| Hospital / Institute | Establish PI LabArchives Account | Approval of Exception | Full Implementation |
|---|---|---|---|
| BWH / MGH | 10/1/2019 | 9/15/2019 | 10/1/2019 |
| MCL / MEE / IHP / SRH | 10/1/2019 | 12/10/2019 | 1/1/2020 |
Does this requirement/policy apply to all research, including clinical research?
Yes, but with some exceptions. The Policy does not apply to:
- Clinical research projects that utilize electronic lab or data management systems, processes, and ELNs that are 21 CFR Part 11 compliant, or
- Sponsor-initiated clinical trials that utilize sponsor systems and processes.
The policy applies to all other active research projects. An Active Research Project is defined as: Award funded by an external sponsor or Sundry fund that is ongoing as of the effective date of the policy.
Am I required to store all Research Data in LabArchives?
No, you are not required to store all Research Data in LabArchives. At a minimum, you are required to document in LabArchives where/how data are generated, stored, accessed and analyzed. There are two ways to document your Research Data.
- Store data directly in LabArchives, or
- Document/reference your data storage in LabArchives for each stage of the data life cycle.
Download LabArchives Quick Guide: Storage
Will LabArchives replace REDCap or Dropbox?
No. REDCap, Dropbox, and other storage solutions will continue to be supported solutions. They have different features / functionality that complement LabArchives and will not be replaced by LabArchives. Please note: Dropbox is not an ELN. It does not include all of the requirements necessary to protect Intellectual Property. Moreover, the searchable organizational (including tags) and versioning control of LabArchives are more advanced than Dropbox.
Mass General Brigham has developed a REDCap external module (EM) that enables you to save reports directly from REDCap into any LabArchives notebook you own.
Am I required to use LabArchives if I'm using REDCap or StudyTRAX or another clinical data capture system?
Yes. REDCap, StudyTRAX and other clinical electronic data capture systems are approved storage for primary data. You must document in LabArchives where your primary data storage is located: include the project name and Project ID and a hyperlink for REDCap projects. You must also use LabArchives to document the Statistical Analysis Plan and store versions of the statistical scripts/code used to generate the output files and the output files for publication (referencing the publication).
Download Guidance: LabArchives and Clinical Research
Can statisticians and data scientists use other tools to track, store and potentially publish their data analysis?
Currently, the only approved application is the MGB-supported GitLab (https://rc.partners.org/gitlab) to publish Statistical Analysis Plans and versions of statistical scripts/code. All other tools must be approved through the exception process. It is strongly recommended that when you have finished debugging your scripts and code, you save a copy of the final working version in the LabArchives research notebook for that project, if the file is within the file size limits for Mass General Brigham's license (4 GB). You should also save a copy into LabArchives when you are preparing to publish, or otherwise submit to an outside entity.
Mass General Brigham, has an enterprise license for LabArchives for all researchers to use at no cost. An ELN is required. LabArchives ELN and is designed for organizing, documenting, and sharing research data with teams, departments, and collaborators. Our enterprise license also allows free use of the LabArchives Inventory and Scheduler tools.
Why is an ELN required?
The requirement for an ELN (e.g., LabArchives) is part of a larger Mass General Brigham Research Data Management Integrity initiative (on the Research Navigator) that was launched in February 2018 to enhance Research Data integrity. The Mass General Brigham Electronic Lab Notebook (ELN) Policy (available internally on Archer) is effective as of May 1, 2019: PIs must use an ELN (e.g., LabArchives) to document Research Data and other record keeping activities for active research projects as of their hospital’s ELN implementation schedule.
Policy Statement: Principal Investigators (PI) of Mass General Brigham (MGB) active research projects must transition from basic data documentation and management methods, e.g., use of MS Word, Excel without controls for auditing and tracking changes, paper laboratory notebooks, and paper processes, to digital technologies/electronic systems, i.e., Electronic Lab Notebooks or Research Notebooks (ELN), in accordance with the implementation schedule. Transition to electronic systems is required to meet regulatory and institutional compliance requirements, mitigate security risks, maintain data integrity, and protect intellectual property.
This Policy does not apply to:
- Clinical research projects that utilize electronic lab or data management systems, processes, and ELNs that are 21 CFR Part 11 compliant, or
- Sponsor-initiated clinical trials that utilize sponsor systems and processes.
| Hospital / Institute | Establish PI LabArchives Account | Approval of Exception | Full Implementation |
|---|---|---|---|
| BWH / MGH | 10/1/2019 | 9/15/2019 | 10/1/2019 |
| MCL / MEE / IHP / SRH | 10/1/2019 | 12/10/2019 | 1/1/2020 |
Does this requirement/policy apply to all research, including clinical research?
Yes, but with some exceptions. The Policy does not apply to:
- Clinical research projects that utilize electronic lab or data management systems, processes, and ELNs that are 21 CFR Part 11 compliant, or
- Sponsor-initiated clinical trials that utilize sponsor systems and processes.
The policy applies to all other active research projects. An Active Research Project is defined as: Award funded by an external sponsor or Sundry fund that is ongoing as of the effective date of the policy.
Am I required to store all Research Data in LabArchives?
No, you are not required to store all Research Data in LabArchives. At a minimum, you are required to document in LabArchives where/how data are generated, stored, accessed and analyzed. There are two ways to document your Research Data.
- Store data directly in LabArchives, or
- Document/reference your data storage in LabArchives for each stage of the data life cycle.
Download LabArchives Quick Guide: Storage
Will LabArchives replace REDCap or Dropbox?
No. REDCap, Dropbox, and other storage solutions will continue to be supported solutions. They have different features / functionality that complement LabArchives and will not be replaced by LabArchives. Please note: Dropbox is not an ELN. It does not include all of the requirements necessary to protect Intellectual Property. Moreover, the searchable organizational (including tags) and versioning control of LabArchives are more advanced than Dropbox.
Mass General Brigham has developed a REDCap external module (EM) that enables you to save reports directly from REDCap into any LabArchives notebook you own.
Am I required to use LabArchives if I'm using REDCap or StudyTRAX or another clinical data capture system?
Yes. REDCap, StudyTRAX and other clinical electronic data capture systems are approved storage for primary data. You must document in LabArchives where your primary data storage is located: include the project name and Project ID and a hyperlink for REDCap projects. You must also use LabArchives to document the Statistical Analysis Plan and store versions of the statistical scripts/code used to generate the output files and the output files for publication (referencing the publication).
Download Guidance: LabArchives and Clinical Research
Can statisticians and data scientists use other tools to track, store and potentially publish their data analysis?
Currently, the only approved application is the MGB-supported GitLab (https://rc.partners.org/gitlab) to publish Statistical Analysis Plans and versions of statistical scripts/code. All other tools must be approved through the exception process. It is strongly recommended that when you have finished debugging your scripts and code, you save a copy of the final working version in the LabArchives research notebook for that project, if the file is within the file size limits for Mass General Brigham's license (4 GB). You should also save a copy into LabArchives when you are preparing to publish, or otherwise submit to an outside entity.
What is an ELN?
An Electronic Lab Notebook, also called an electronic research notebook, or ELN, is a computer program designed to replace paper laboratory notebooks.
A lab notebook is a primary record of research used to document hypotheses, experiments, observations, and analysis and interpretation of experimental activity. Lab notebooks also have a secondary Intellectual Property protection purpose and are often used in patent prosecution.
To ensure the integrity of entries related to authorship, content and time, the use of electronic lab notebooks for research purposes in regulated industries, such as medical device and pharmaceutical industries, must comply with FDA regulations related to software validation. Unlike ELNs for patent protection, the FDA is not concerned with patent interference proceedings, its concerns are focused on data falsification prevention. Provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and Title 21 CFR Part 11.
In addition to documenting data integrity to regulators, researchers may also be called upon to demonstrate the integrity of their Research Data to their home institutions, government agencies, sponsors, and publishers. Transition to electronic systems enables researchers to preserve the integrity of their primary data with minimal effort and ensures the processes used to publish outcomes are transparent and reproducible. Tracking your research in an electronic notebook makes it easier to organize and find your data in order to comply with data sharing requirements.
More about Mass General Brigham Research Data Management Requirements can be found on the Research Navigator. The Links to Data Management Templates, Budgeting Guidance, and the Data Sharing Limitations policy and other useful resources are accessible from that page, as well. Check the page frequently, as policies are added and updated regularly in response to new information and guidance from the NIH and leadership.
How does LabArchives compare to other Mass General Brigham Enterprise Applications?
A few Mass General Brigham Enterprise Applications may appear meet the ELN Policy requirements, however, they do not meet the definition of an electronic lab notebook for the purposes of data integrity, transparency, reproducibility, and legal documentation for patent prosecution. See the page LabArchives vs other Mass General Brigham Enterprise Apps
How is LabArchives supported by Mass General Brigham?
Mass General Brigham has funded a multi-year enterprise contract with LabArchives, LCC and has made LabArchives available to all Mass General Brigham Researchers at no cost. Under the terms of the contract, LabArchives has agreed provide direct end-user support (@email) and training as follows:
- Introduction to LabArchives: Every Thursday at 1pm EST - REGISTER
- Introduction to Widgets (custom forms in a notebook): To schedule a personalized webinar training on widgets, contact @email
Does LabArchives require installation of software or is it a web-based application?
LabArchives is a web-based application.
Since this is a web-based notebook, Wifi and network connections are a major concern for our lab. Will the institution provide adequate infrastructure to support?
RISC will work with Network Engineering regarding labs/locations and on prioritizing this app over the priority link. If you have issues, please email @email with your building and floor location so that we can have Network Engineering look into your coverage.
Is LabArchives both Mac and PC compatible?
Yes, you can access on any device. LabArchives is entirely web-based, and is device responsive, so it can be used on any device with a web browser.
Where are the data stored?
AWS Hosted Solution; Reviewed by Information Security. Backup & Disaster Recovery Plans are supported by LabArchives.
Is the data format proprietary?
No, you can export data to PDF or HTML. More information about offline notebooks is available at: https://help.labarchives.com/hc/en-us/articles/11778416826004-Create-Offline-Notebook
Is LabArchives HIPAA compliant? Can I enter PII or PHI data?
Yes, you can enter PII or PHI into LabArchives. LabArchives has completed a Vendor Risk Assessment and MGB Infosec confirms that controls and contracts are in place to ensure we can store MGB PII/PHI within their system. LabArchives has also been assessed by the Mass General Brigham Information Security Risk Assessment Team to ensure compliance with all Mass General Brigham HealthCare policies.
There is concern when using a commercial software vendor in that access and continued use is dependent on the company's support and financial health. What is the long term plan with this vendor?
Mass General Brigham has a multi-year contract with LabArchives which includes contingency planning. The vendor has been reviewed and vetted through contracts, security and research management.The formats and data saves are not proprietary formats, they are HTML and PDF. All data is owned and will always be accessible by Mass General Brigham.
Can I Delete a Notebook?
Mass General Brigham does not allow people to delete notebooks. If there is a notebook you do not plan to use, you may hide it from the notebook list using the Notebook Manager.
Integrations
LabArchives is Integrated with Major Lab Applications including: GraphPad Prism, MS Office, Vernier Logger Pro, SciSpace, SnapGene, Qeios, Jupyter, Protocols.io, DataCite
Check out their knowledgebase for information about these integrations.
There are options to work within your MS Office documents AND utilize LabArchives version control and revision history features.
1) MS Office Document Editor Option: Allows you to create and edit MS-Office compatible documents from within your Notebook. These document types include:
- Word Documents
- Excel Spreadsheets
- Powepoint Presentations
You can upload pre-existing Office files from your computer, and continue to edit them within LabArchives using the Online Editor: MS Office Online (Office 365). You can also create new Office Documents within LabArchives itself.
To upgrade to Office 365, please contact the IS Service Desk.
-
- Mass General Brigham full time employees are eligible for MS Office 365 licenses. POI, Vendor, Service Account related user accounts are not eligible and will required evaluation prior to provisioning if requested.
- For more information on Mass General Brigham MS Office 365: https://rc.partners.org/research-apps-and-services/get-software#microsoft-office-products
- For non-standard windows or Mac devices:
2) MS Office Plugins: Allow you to open Microsoft Office Documents directly, and once done editing a file, save the file back to the notebook without even being logged into LabArchives via the web browser.
3) REDCap: Allows you to save reports into a notebook you own, without leaving REDCap. When you have data prepared for analysis or for publication in a paper, you can save a snapshot of the data into LabArchives via a button in REDCap. This is enabled by an External Module developed at MGB. Contact @email if you need the module enabled on your project.
Paper vs Electronic Lab Notebook
Different approaches are available depending on whether personal laptops and/or mobile devices are permitted and funded by the lab. There are protective coverings for devices and keyboards in the lab. Items to think about:
- What is the lab/research environment?
- Are their restrictions on what can be brought in/taken out of the lab?
Many labs use a tablet that always remains in the lab for ELN purposes.
ELN Opinions at MGB
There are positive opinions about electronic lab notebook:
"We already use the Mass General Brigham LabArchives system, and this has been very beneficial to our lab."
"I very much like the idea of an ELN and after talking to my lab group have decided by incorporate this into our daily operations. Hand written lab notebooks take up space, they are exceedingly difficult to find relevant information in a timely manner, and they are very limited to what can be included as supporting material. The ELN sounds like a very significant step forward in all regards."
There are many opinions about paper:
"Paper-only is superior in nearly every way to an electronic-only version. The only improvement to paper-only would be to have automatic capture of written notes into a searchable, auditable PDF format." - This can be accomplished in LabArchives: You can scan paper and upload to LabArchives, or use Optical Character Recognition software on your device to photograph your notes, then put the resulting files into LabArchives (How can I use handwriting or draw sketches in LabArchives). PDFs become searchable and date time stamped. You can also annotate the PDF.
"Pen and paper also has tremendous benefits, especially in the hazardous lab environment." - We have a group that actually required devices in their lab because it was easier to protect and sanitize than paper. All environments are different and must be reviewed for best practices.
"[It] would also be difficult to buy computers for each person in lab to document lab work- as notebooks need to be very close to the bench and readily accessible to each person" - Funding is a serious consideration. The goal is that by going digital, your lab efficiencies improve - saving you time and resources that you can funnel back into technologies to support your research.
Data transfer scenarios / Allowing individuals to take copies
Mass General Brigham’s policies allow a departing researcher (e.g., postdoctoral fellow or PI) to take copies of research data with him or her when leaving a Mass General Brigham hospital or institution for another employer. In accordance with Mass General Brigham Policies on Data Stewardship, Access, and Retention, the PI should have the role “Owner” of all notebooks in his/her lab. This will ensure that no information is lost when an individual leaves Mass General Brigham and loses access associated with his/her Mass General Brigham username.
HOW TO: Transfer Ownership of LabArchives Notebooks
FOR A POSTDOCTORAL FELLOW OR (ANY RESEARCHER OF NON-PI STATUS):
- All LabArchives Notebook ownership must be transferred to the PI immediately or shortly after notebook creation.
- If notebook ownership is not transferred prior to individual leaving Mass General Brigham, PIs can contact labarchives@mgb.org. RISC LabArchives Administrators will help manage notebook transfer.
- PI must determine and approve what notebooks and data can be copied for the individual's retention after leaving the institution. See Creating Notebook Copies section below.
WHEN A PI LEAVES MASS GENERAL BRIGHAM:
PI must comply with PI Transfer Out SOP (PDF download) and PI Transfer Packet: BWH and MGH have different transfer packets. Both can be found on the Research Management Intranet.
All data is retained on the LabArchives servers as Mass General Brigham data. Original notebooks will not be transferred to non-Mass General Brigham accounts. A transferring PI must contact the MGB LabArchives Support Desk (labarchives@mgb.org) once they've completed the transfer out process for their institution, for information on transferring a copy of their notebooks to their new institution.
LABARCHIVES OFFERS TWO WAYS TO DOWNLOAD AN OFFLINE, READ-ONLY COPY OF THE NOTEBOOK. THESE OPTIONS INCLUDE AND HTML AND PDF COPY:
- HOW TO: Create Notebook PDF Copy The Notebook to PDF option will create a .pdf of the notebook.
- HOW TO: Create Notebook HTML Copy The "Create Offline Notebook" option will create an HTML version of your notebook.
What Do I Do with My Files?
A common question is related to file storage. You can get deeper details from the Quick Start Guide for Storage, but here's a simplified rundown.
When determining how to manage your files, keep in mind that the policy requires your LabArchives notebook(s) be a one-stop location to find anything needed to reproduce your research results. Your raw data does not need to be stored in LabArchives (though it's ideal if it can be), but an auditor needs to be able to find it, based on information provided in your LabArchives notebook, and there must be sufficient controls on the data that it will be possible to identify who made what changes, when. MGB-approved storage options provide these controls.
Many labs do work that creates a large volume of files. For example, MRI or microscopy images, or Excel spreadsheets containing data about patients who have had certain tests, and so on. Here are the options available, based on the type of file and where it's stored:
If a file is stored on your local hard drive, you have the following options:
- Use MS Office integration to automatically save into LabArchives when you save or edit a Microsoft Office file. This also allows you to use the (somewhat limited) MS Office online editing features for collaborative editing in real-time, in addition to normal editing of the file, directly on your computer.
- Use LabArchives' Folder Monitor to automatically add it to your notebook, specifying rules that will place it where you want it.
- Manually add a copy of the file to LabArchives at important junctures (such as each draft of an article being submitted for publication, of a grant application, of a patent application, etc.)
If a file is stored in an MGB SFA, Dropbox, or other remote, MGB-approved secure file storage location:
- Add a description of the file and information about its location - either the server name and file system path, or the file's URL to LabArchives. Remember to update LabArchives if you move files!
- When submitting for a publication, a grant, a patent, etc., store in LabArchives a copy of the formatted version of the file (.jpg, .png, etc.) that will be submitted, along with the other content for that submission.
For very large files that cannot fit in LabArchives (such as certain types of images):
- Add a description of the file and information about its location - either the server name and file system path, or the file's URL to LabArchives.
- When submitting for a publication, a grant, a patent, etc., store in LabArchives a copy of the formatted version of the file (.jpg, .png, etc.) that will be submitted, along with the other content for that submission.
For code and scripts, use GitLab for version control, and store the final/functioning versions used in your research in LbArchives:
- Add a description of the code or script(s) to your notebook, along with the GitLab URL.
- When submitting for a publication, a grant, a patent, etc., store a copy of the working version of the code/script(s) that was used to generate results.
SERVICE CONTACTS:
LabArchives Support: @email
Mass General Brigham Support: labarchives@mgb.org
| Guidance Documents |
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LabArchives: Quick Start for PIs | PDF LabArchives Quick Guide: Storage | PDF LabArchives and Clinical Research | PDF |
Digital Research Operations Enterprise Research Applications provides standard business-hours support (9AM to 5PM, Monday - Friday) for all supported applications systems. Any off-hours support will be provided on a best-effort basis, but is not guaranteed.