LabArchives vs other Partners Enterprise Apps

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.

REDCap, Dropbox, and other storage solutions will continue to be supporting solutions. They have different features / functionality that will compliment LabArchives as these features and functions are not available in the LabArchives ELN.

ELN Requirements

ELN: LabArchives

Data Mangement Tool:  REDCap

Data Storage / Collaboration Tool: Dropbox Business

1. Must be compliant with all Partners Enterprise Information Security Policies, Standards, and Procedures. Yes Yes Yes

2. Must be compliant with applicable regulatory and legal requirements evaluated and applied where appropriate including, but not limited to:

  • Health Insurance Portability and Accountability Act (HIPAA);
  • Mass General Law, Chapter 93H (M.G.L.c.93H); and
  • EU General Data Protection Requirement (GDPR) if the Research Data include personal data collected in the EU, and the research is operating under a contract or research agreement with GDPR terms.
Yes Yes Dropbox is approved for Institutional and Confidential data, including Protected Health Information (PHI), at Partners HealthCare, but may not meet all regulations governing data protected under specific contracts and federal regulations. See Dropbox Business FAQ
3. ELN Systems that include signing and witnessing of electronic records with electronic signatures must also comply with Title 21 of the Code of Federal Regulations (21 CFR Part 11.) Yes YES, but not proven. See REDCap: Compliance No
4. The ELN must include Data Integrity Controls for the entire Data Life Cycle.  These include, but are not limited to:
  • Date time, user, and action logs of any modification to Primary Data
  • Inability to delete primary data or deletion with appropriate deletion logs
  • Control of Primary Data access by PI and/or Lab Manager or designee
  • Documentation of Research Data chain of custody (i.e. Ownership, PI Transfer In/Out)
  • Logs that record access to primary data sharing activities
Yes Yes

Yes

 

For all Active Research Projects as of Oct. 1, 2019, Researchers should use LabArchives to:

  1. Document Data Lifecycle in line with the Partners Research Data Management Integrity initiative
  2. Document Statistical Analysis processes and procedures about data prepared for publication, grant submission, or provided to sponsors or reporting agencies.

GOAL: Ensure Data Integrity, Transparency and Reproducibility

Application Data Life Cycle Statistical Analysis Plan
REDCap Good for primary/source data storage and also archiving at study close. Reference REDCap project ID in LabArchives documentation. Data must be exported from REDCap for analysis. Document SAP in LabArchives
Dropbox Business Good for primary/source data storage, data in use, archiving, and MS Office document storage. Reference folder/directory in LabArchives documentation. Good for output file storage, Reference folder/directory in LabArchives documentation.

 

LabArchives Quick Guides: Storage https://rc.partners.org/labarchives

Partners Secure Storage Solutions: https://rc.partners.org/storage

Partners Enterprise Dropbox: https://rc.partners.org/dropbox

  • Dropbox does not have a statement on 21 CFR Part 11 Compliance. It is a recommended storage solution because it does comply with other data integrity requirements such as: revision history, authorization by Partners account, access controls. Acceptable for record keeping activities and data use storage if Part 11 compliance is not needed. Limitations may include data storage limits.