Clinical sample tracking helps scientists and research teams know where samples are in the receiving, storage, testing and analysis process. This allows researchers to quickly identify information regarding the patient/study participant, previous assay runs, derivative samples, storage location, history, and more.
When dealing with human-derived samples, tracking the chain of custody and storing sample-related data in a secure environment is vital. Unfortunately, many research groups are still relying on paper trails for clinical sample tracking due to the low cost and familiarity of the approach. These “paper solutions” are highly error-prone, difficult to scale, and difficult to adapt to increasing complexity in the lab. This can greatly reduce productivity, delay execution of a research study, and can pose regulatory compliance risks. For these reasons, selecting a sample management software designed for clinical sample tracking is critical for success.
When looking for a clinical sample tracking system, consider the following:
- Is clinical sample data being stored securely with the proper safeguards to ensure regulatory compliance?
LabKey Sample Manager offers CFR Part 11, HIPAA and FISMA compliant software and hosting, used by leading life science organizations and the FDA. This includes built-in methods to restrict PHI/PII data access, and e-Signing data, managing sensitive data in a secure way is easy and transparent.
- Is the sample’s chain of custody captured in the system and easy to retrieve?
Not only does Sample Manager create audit-ready logs for all sample events, we have a unique Sample Timeline that allows users to easily browse a sample-centric chain of custody for auditing and troubleshooting.
- Can you customize fields and add built-in validation to ensure correct data entry?
Sample Manager allows administrators to add validators to both numeric and text fields to ensure correct data entry. Quality Control tools allow assay data to be reviewed before it’s shared to ensure that only relevant data is displayed to teams.
- Can the clinical sample tracking system provide built-in reporting capabilities that create custom reports unique to your lab’s needs?
LabKey has built-in reporting and charting tools to quickly assess the data, as well as many advanced tools such as built in R and SQL reporting, integrations with Tableau, Spotfire, etc.
- Can I capture participant clinical data within the same tool to centralize my data?
LabKey has an extensive study module that integrates with our clinical sample tracking system that allows teams to capture all clinical data. We integrate with REDCap and Medidata RAVE as well. Our study publishing capabilities allow teams to share information with collaborators in a secure way including date-shifted and de-identified data.