When adopting LabArchives and especially for use by researchers in the health sciences, questions surrounding the management of clinical research data are often raised. Many institutions have approved LabArchives for the storage of all PHI (Personal Health Information) and then others that allow only de-identified PHI to be stored in LabArchives.
Tip: We recommend that each institution establish a policy to advising researchers working with sensitive data. Check with your local institution leadership to see what is allowed, encouraged, or recommended. Your institution may provide a grid or table listing details about the various storage options available. In some cases, your institution may provide specific discipline guides.
Questions for your institution:
- What type of data is allowed or not allowed in LabArchives?
- If a dataset is not allowed in LabArchives, where should it be stored?
- What is the recommended method for linking to or referencing data stored outside of LabArchives?
Things to consider: LabArchives has successfully passed numerous network and application security tests from multiple institutions and companies. Regular backups of private customer data are kept in multiple locations in encrypted form and each customer’s data is stored in its own database, isolated from other customer data. For more details on our security and compliancy standards, please visit Trust, Security & Compliance.
LabArchives is not just for Wet Labs!
LabArchives provides a secure method for storing data that allows you to collaborate with colleagues both in and out of the lab. It can be used for documenting any research process, keeping track of workflows, data from clinical trials, or other non-wet lab or dry bench research. Access controls are available at the notebook level and put the notebook owner in full control of who has access to their data.
Researchers use LabArchives as the official record of their research to document what has been done, where, and when and then appropriately point to the files in the other system. For clinical researchers,
Link or reference data stored externally.
It could be the case that you already have a system in place that you have approved for the storage of PHI (such as REDCap). If so, you can continue to use that application for storing the data. Simply create a link or a file path to the survey, report, or data and enter that information in a Rich Text Entry in LabArchives. LabArchives might contain the notes, observations,
To learn more about linking to data Click Here.
Key sheets or Coded Data
In some cases, collected data samples may have a unique random code. There can be a “key sheet” or page to assist the researchers with connecting a patient or sample to the unique random ID. Often the Key sheet or linkage file is stored in a secure location which only a subset of researchers has access to. It may make sense to keep this key outside of LabArchives or to have the details in a totally separate notebook with restricted access.
Access Roles and Double-Blind Studies
In LabArchives, it’s possible to restrict access to specific notebooks or folders. If some of your clinical research should be kept private from other members of the team, consider restricting colleagues with read only access or setting up designated notebooks for the restricted data. To learn more about user roles Click Here.
Often when preparing a publication, you’ll need a place to store correspondence with the publisher, data management plans, funding information, supplementary data, and other details associated with the paper. As an example, it can be very helpful to track each draft of a certain publication. In the future, you can review feedback provided by a colleague or details that may have been changed as part of the peer review process. Consider creating a folder for each publication, within the folder have a page for each manuscript draft, and any additional resources related to the draft like feedback or corrections.
For some clinical researchers the primary data may be stored in other systems. Often, LabArchives might become more of a project management tool. As an example, if you meet with a supervisor or if you have a weekly lab meeting, consider documenting the meeting minutes in LabArchives. You can collaboratively edit the entries and review previous meetings.
REDCap is often used for surveys and clinical research. Once the results have been collected reports from REDCap can be sent to a LabArchives notebook using the REDCap integration. To learn more about the integration Click here.
Pages in LabArchives can organized with a specific structure and the page can be copied frequently. These templates provide your team with consistent formatting and make it easier to track information outside of LabArchives. As an example, you might develop a template for specific protocols or processes. Often, for clinical research, the notebook contains links and references to datasets stored outside of LabArchives and includes details like code, scripts and analysis.
Many reserachers create a customized and standard form using widgets. Once created, this form can be reused by all members of the notebook to provide consistency and a clear list of data requirements. To learn more about widgets in LabArchives, Click Here