LabArchives: Getting Started

LabArchives ELN: Getting Started, Policy and FAQ 

Getting Started

SHORT DESCRIPTION:  

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.  LabArchives include tools for document collaboration, data input forms, inventory management, and resource scheduling. Use of LabArchives enhances Research Data integrity and protects researchers and intellectual property against claims of research misconduct or claims of prior art. 

Access rights are controlled by the notebook owner (PI) and can be customized to suit the individual needs of each researcher, educator, or contributor.  

HOW TO INITIATE THIS SERVICE: 

Login to LabArchives by selecting Mass General Brigham from the list of SSO-organizations and your account is automatically created.  

SERVICE CONTACTS: 

Supported by LabArchives team and MGB Digital Research Applications Team. 

  • For questions about application use and features, contact LabArchives Support: @email 
  • For questions about MGB-specific ELN use policies, procedures, and notebook transfers, contact Mass General Brigham Support: @email
    • ServiceNow / Service Desk Group: Digital Research Apps - mgb
    • Configuration Item: LabArchives – mgb 

Additional resources:  

 

Guidance documents 

  • LabArchives: Quick Start for PIs | PDF
  • LabArchives Quick Guide: Storage | PDF
  • LabArchives and Clinical Research | PDF 

 Digital Research Applications provides standard business hours support (9AM to 5PM ET, Monday - Friday) for all supported systems.   


MASS GENERAL BRIGHAM ELECTRONIC LAB NOTEBOOK (ELN) POLICY 

USE OF 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).   

  • PIs are required to establish a LabArchives account in their name, create notebooks and set as an owner, and designate notebook access for their research staff.  

  • PIs must be set as notebook owners for all notebooks used in their lab.  

The MGB Digital Research Operations Enterprise Research Applications team (Digital ERA) has secured an enterprise license and provides access and support for LabArchives ELN at no cost for researchers to meet these requirements. 

 

DATA TRANSFER AND NOTEBOOK COPIES POLICY 

What if PI or a lab member leaves the organization? Data transfer scenarios / allowing individuals to take copies policy 

Mass General Brigham’s policies allow a departing researcher (e.g., postdoctoral fellow or PI) to take copies of research data with them 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 lab member leaves Mass General Brigham and loses access associated with his/her Mass General Brigham username. 

When a postdoctoral fellow (or any researcher of non-PI status) leaves Mass General Brigham: 

  • 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. MGB Digital 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 the “Creating Notebook Copies” section below.  

When a Principal Investigator 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 html and pdf copy: 

  • HOW TO: Create Notebook HTML Copy   The "Create Offline Notebook" option will create an HTML version of your notebook. 

FREQUENTLY ASKED QUESTIONS

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. LabArchives is an ELN.  

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. 

 

Why is an ELN required? 

A robust, secure ELN that has features such as immutable timestamps, protects Mass General Brigham researchers and intellectual property against claims of research misconduct or claims of prior art. 

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 MGB-approved 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). Transition to electronic systems is required to meet regulatory and institutional compliance requirements, mitigate security risks, maintain data integrity, and protect intellectual property. 

 

Does this requirement/policy apply to all research, including clinical research? 

The policy applies to all active research projects, defined as “Award funded by an external Sponsor or sundry fund that is ongoing as of the effective date of the policy”. 

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. 

 

 

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: 

  1. Store data directly in LabArchives - appropriate for smaller files, such as MS Office files, PDFs, etc., or 

  1. Document or reference your data storage in LabArchives for each stage of the data life cycle. For example, if files are stored in a folder in OneDrive or Dropbox, put a description of the files and the path to the file or folder into LabArchives. 

 
Note: if you have large files or very large numbers of files (such as auto-generated microscopy), the best place to store it depends on several factors. See the Storage and Backup page to help figure out the best storage tool(s) for your work. 

 

Am I required to store all research data in LabArchives? How do I manage mdata files?  

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.   

When determining how to manage your files, keep in mind that the policy requires your LabArchives notebook(s) to 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 size and type of file, and where it's stored: 

 

FILE TYPE 

STORAGE OPTION 

Files is stored on your local hard drive 

  1. Use MS Office integration to automatically save to 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. 

  1. Use LabArchives' Folder Monitor to automatically add it to your notebook, specifying rules that will place it where you want it. 

  1. 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.) 

Files stored in an MGB SFA, Dropbox, or other remote, MGB-approved secure file storage location 

  1. 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! 

  1. 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. 

Very large files that cannot fit in LabArchives (such as certain types of images) 

 

  1. 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. 

  1. 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. 

Code and scripts, e.g. statistical analysis plan, algorithms, ML models 

 

  1. Use GitLab for version control, and store the final/functioning versions used in your research in LabArchives: 

  1. Add a description of the code or script(s) to your notebook, along with the GitLab URL.  

  1. 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. 

 

 Will LabArchives replace REDCap or Dropbox? 

No. REDCap, Dropbox, and other MGB-approved storage solutions continue to be supported. 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 options for primary data.  You must document in LabArchives where your primary data storage is located: include the project name, 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. 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. This will time-stamp the working code to prove when it was created and by whom. 

 

How does LabArchives compare to other Mass General Brigham Enterprise Applications? 

A few Mass General Brigham Enterprise Applications may appear to 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 

 

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, Wi-Fi and network connections are a major concern for our lab. Will the institution provide adequate infrastructure to support? 

We will work with Network Engineering regarding labs/locations and 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 it on any device. LabArchives can be used on any device with a web browser. 

 

Where are the data stored? 

Data is stored on LabArchives servers, hosted by AWS; The solution has been reviewed by Information Security, and they have extensive backup & disaster recovery plans. 

 

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 that using a commercial software vendor the access and continued use is dependent on the company's support and financial health. What is the long-term plan for 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 by un-checking "Include in Navigator?" in the Notebook Manager.  

 

How Can I Use an Electronic Lab Notebook while in the lab? 

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 there 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. 

INTEGRATIONS 

Lab applications:  

LabArchives is integrated with major lab applications including: GraphPad Prism, MS Office, Vernier Logger Pro, SciSpace, SnapGene, Qeios, Jupyter, Protocols.io, DataCite 

Check out LabArchives knowledgebase for information about these integrations. 

MS Office 

There are options to work within your MS Office documents AND utilize LabArchives version control and revision history features. 

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 

  • PowerPoint 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 require evaluation prior to provisioning if requested. 

 

MS Office Plugins

Allow you to open Microsoft Office Documents directly, and once you have done editing a file, save the file back to the notebook without even being logged into LabArchives via the web browser.  

REDCap:  

Allows you to save reports into a notebook you own, without leaving REDCap. When you have data prepared for analysis or for publication, you can save a snapshot of the data into LabArchives via a button in REDCap. To enable the LabArchives External Module developed at MGB for your project please contact @email 

Go to KB0034055 in the IS Service Desk