Enterprise Research Infrastructure & Services, ERIS, has an enterprise license for LabArchives for all researchers to use at no cost. LabArchives is designed for organizing, documenting, and sharing research data with teams, departments, and collaborators.
Why is LabArchives required?
LAbArchives is part of a larger Partners Research Data Management Integrity initiative (on the Research Navigator) that was launched in February 2018 to enhance Research Data integrity. The Partners Electronic Lab Notebook (ELN) Policy (available internally on Archer) is effective as of May 1, 2019: PIs must use LabArchives to document Research Data and other record keeping activities for active research projects as of their hospital’s ELN implementation schedule.
|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 Sata.
- 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 supporting solutions. They have different features / functionality that will compliment LabArchives and 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.
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 Partners-supported GitLab (https://rc.partners.org/gitlap) to publish Statistical Analysis Plans and versions of statistical scripts/code. All other tools must be approved through the exception process.
How do I request an exception to this policy?
Laboratories, research groups and departments with well-established electronic lab or data management systems, processes, and ELNs may request approval to continue with their system(s) in lieu of LabArchives provided their system(s) meet the minimum standards outlined in the policy. Please see the ELN Policy Exception Request page for minimum standards and request form.
An electronic lab notebook, also known as electronic research notebook, or ELN, is a computer program designed to replace paper laboratory notebooks.
A lab notebook 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.
More about Partners Research Data Management Requirements can be found on the Research Navigator.
How does LabArchives compare to other Partners Enterprise Applications?
A few Partners 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 Partners Enterprise Apps
How is LabArchives supported by Partners?
Partners has funded a multi-year enterprise contract with LabArchives, LCC and has made LabArchives available to all Partners Researchers at no cost. Under the terms of the contract, LabArchives has agreed provide direct end-user support (email@example.com) and training as follows:
- Introduction to LabArchives: Every Thursday at 1pm EST - REGISTER
- Introduction to Widgets: To schedule a personalized webinar training on widgets, contact firstname.lastname@example.org
Does LabArchives require installation of software or is it 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?
ERIS will work with Network Engineering regarding labs/locations and on prioritizing this app over the priority link. If you have issues, please email edcsupport 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. There is also a Mobile App for iOS and Android: http://labarchives.kayako.com/Knowledgebase/List/Index/226/7-la-mobile-apps-and-3rd-party-applications
Where are the data stored?
Is the data format proprietary?
No, you can export data to PDF or HTML. More information about offline notebooks is available at: http://labarchives.kayako.com/Knowledgebase/Article/View/53/0/68-create-offline-notebook
Is LabArchives HIPAA compliant? Can I enter PII or PHI data?
Yes, you can enter PII or PHI into LabArchives which has been validated by ERIS / EDC Support team to ensure it meets HIPAA requirements. LabArchives has also been assessed by the Partners Information Security Risk Assessment Team to ensure compliance with all Partners HealthCare policies. Partners also has a Business Associates Agreement in place with the Vendor.
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?
Partners 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 Partners.
LabArchives is Integrated with Major Lab Applications including: GraphPad, MS Office, ChemDoodle, Vernier, FlowJo. Check out their knowledgebase about these integrations.
How is LabArchives integrated with MS Office (Word, Excel)?
There are options to work within your MS Office documents AND utilize LabArchives version control and revision history features.
1) Office Document Editor Option: Allows you to create and edit MS-Office compatible documents from within your Notebook. These document types include:
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.
- Partners 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 Partners MS Office 365: http://sharepoint.partners.org/phs/microsoftoffice/SitePages/Home.aspx
- 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.
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?
There are positive opinions about electronic lab notebook:
"We already use the Partners 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. PDFs become searchable and date time stamped. You can also annotated 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
Partners’ policies allow a departing researcher (e.g., postdoctoral fellow or PI) to take copies of research data with him or her when leaving a Partners hospital or institution for another employer. In accordance with Partners 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 Partners and loses access associated with his/her Partners username.
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 Partners, PIs can contact email@example.com. ERIS LabArchives Administrators will request notebook ownership transfer to be completed by the vendor.
- 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 Partners:
For a PI with a named successor at Partners:
- All LabArchives Notebook ownership must be transferred to the successor PI prior to leaving the institution.
- If notebooks are not transferred, successor PIs can contact firstname.lastname@example.org. ERIS LabArchives Administrators will request notebook ownership transfer to be completed by the vendor.
For a PI leaving without a successor at Partners (transfer to non-Partners, external institution).
- Data can be copied for the individual leaving the institution. See Creating Notebook Copies section below.
Create Notebook Copies
When copies or clones of notebooks, pages, sections are created, all original data remains property of Partners. No data is deleted. All data is retained on the LabArchives servers as Partners data. Original notebooks will not be transferred to non-Partners accounts. Users must first clone a notebook.
HOW TO: Create Notebook Clone
- You may only Clone notebooks you own.
- Cloned notebooks will appear exactly as the original, including a duplicate revisions history for all items in the notebook.
- The only difference between the clone and the original will be that the clone has "- copy" added at the end of it's name.
- Cloned notebooks can be transferred to a non-Partners account by contacting email@example.com. ERIS LabArchives Administrators will confirm transfer is approved by appropriate hospital research administration and Research Management, then will request notebook ownership transfer to be completed by the vendor. The non-Partners user must also agree to LabArchives terms, agreements and service costs for their new LabArchives account.
LabArchives offers two ways to download an offline, read-only copy of the notebook. These options include and HTML and PDF copy:
- Is it both Mac and PC compatible?
- Since this is a web-based notebook, Wi-Fi and network is a big concern for our lab. Will the institution provide adequate infrastructure to support?
- Does LabArchives require installation of software or is it web-based?
- Does this requirement apply to all researchers, including clinical?
- Is it HIPAA compliant? Can I enter PII or PHI data into LabArchives?
- How is LabArchives integrated with MS Office (Word, Excel)?
- Where is the data stored?
- Is the data format proprietary?
- Will this system be replacing REDCap or Dropbox?
- What is the long term plan with this vendor?
- What happens when the PI leaves Partners?