Tag: Sample Manager

For researchers, clinical data management and reporting has historically included manual curation and compilation of datasets from disparate data warehouses. In today’s data-rich environment, manual processing and integration is becoming more and more of a bottleneck.

In order to keep up with the increasing amount of data collected from clinical research, clinicians and statisticians alike need software tools that will centralize their data and help them quickly recognize errors. LabKey Server provides essential tools to overcome these, and other key clinical research challenges including:

Maintaining Clinical Data Integrity

Having an accurate representation of clinical data helps transform discoveries and understanding into patient care and treatment. Centrally-housing data in a compliant environment that enforces data standardization can help clinicians maintain excellent data integrity and provide an authoritative view of their data landscape.

LabKey Server helps maintain data integrity by providing:

• A highly structured data environment with enforceable data fields to ensure data is entered correctly and within range
• Quality control measures such as data flags, QC of datasets and built-in QC reports
• Role and group-based permission levels that allow users only access to what they need access to
• A compliance module, the allows users to set PHI securities, set Terms of Use for users, and provide electronic signatures on data snapshots

Integration of Data from Multiple Sources

Bringing together data from disparate sources into a single system can help clinical research stay on track and on time. Collaborative monitoring of data quality by clinicians, statisticians, and scientists enables quick identification of erroneous data and ensures a reliable, integrated data landscape for comprehensive data analysis.

LabKey Server helps facilitate comprehensive data integration by providing:

• Management of lab data together with clinical data in a single system
• A study module that can recognize and integrate disparate vendor datasets
• Built-in and customizable integration with electronic data capture systems and case report forms
• A clinical document abstraction pipeline, which can extract valuable data from legacy documents

Secure Reporting and Collaboration

A key component of effective clinical data management is the ability to share reports and data with collaborators to improve research, innovation, and ultimately patient care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in clinical research where patient safety and care is the top priority.

LabKey Server improves reporting and collaboration by providing:

• Dynamic and static reporting tables and visualizations that can be shared as-needed
• Web-based access to a central platform for data sharing
• The ability to remove PHI fields or provide randomized IDs when sharing information with collaborators

With the right tools for clinical data management, research teams can eliminate data integration bottle necks and curate reliable datasets for analysis. Explore our example Longitudinal Study or Sign-up for a free trial to see how LabKey Server can help your team overcome these, and other common clinical research challenges.

Related Documentation

Read more about the features highlighted above on the LabKey Support Portal:

• Data Quality Control
• Security & Permissions
• Compliance Module
• Longitudinal Study Tools
• File Watchers – Automated Directory Monitoring
• Clinical Document Abstraction

For researchers, clinical data management and reporting has historically included manual curation and compilation of datasets from disparate data warehouses. In today’s data-rich environment, manual processing and integration is becoming more and more of a bottleneck.

In order to keep up with the increasing amount of data collected from clinical research, clinicians and statisticians alike need software tools that will centralize their data and help them quickly recognize errors. LabKey Server provides essential tools to overcome these, and other key clinical research challenges including:

Maintaining Clinical Data Integrity

Having an accurate representation of clinical data helps transform discoveries and understanding into patient care and treatment. Centrally-housing data in a compliant environment that enforces data standardization can help clinicians maintain excellent data integrity and provide an authoritative view of their data landscape.

LabKey Server helps maintain data integrity by providing:

• A highly structured data environment with enforceable data fields to ensure data is entered correctly and within range
• Quality control measures such as data flags, QC of datasets and built-in QC reports
• Role and group-based permission levels that allow users only access to what they need access to
• A compliance module, the allows users to set PHI securities, set Terms of Use for users, and provide electronic signatures on data snapshots

Integration of Data from Multiple Sources

Bringing together data from disparate sources into a single system can help clinical research stay on track and on time. Collaborative monitoring of data quality by clinicians, statisticians, and scientists enables quick identification of erroneous data and ensures a reliable, integrated data landscape for comprehensive data analysis.

LabKey Server helps facilitate comprehensive data integration by providing:

• Management of lab data together with clinical data in a single system
• A study module that can recognize and integrate disparate vendor datasets
• Built-in and customizable integration with electronic data capture systems and case report forms
• A clinical document abstraction pipeline, which can extract valuable data from legacy documents

Secure Reporting and Collaboration

A key component of effective clinical data management is the ability to share reports and data with collaborators to improve research, innovation, and ultimately patient care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in clinical research where patient safety and care is the top priority.

LabKey Server improves reporting and collaboration by providing:

• Dynamic and static reporting tables and visualizations that can be shared as-needed
• Web-based access to a central platform for data sharing
• The ability to remove PHI fields or provide randomized IDs when sharing information with collaborators

With the right tools for clinical data management, research teams can eliminate data integration bottle necks and curate reliable datasets for analysis. Explore our example Longitudinal Study or Sign-up for a free trial to see how LabKey Server can help your team overcome these, and other common clinical research challenges.

Related Documentation

Read more about the features highlighted above on the LabKey Support Portal:

• Data Quality Control
• Security & Permissions
• Compliance Module
• Longitudinal Study Tools
• File Watchers – Automated Directory Monitoring
• Clinical Document Abstraction

For researchers working in a regulated laboratory environment, preparing for an audit can be a daunting task. This is especially true if your records, staff training and SOPs have been neglected for a long period of time. Trying to play “catch up” once you learn about an impending audit will almost always be a losing proposition. Once you learn about an upcoming audit it will help to first understand the scope and depth of the audit. This will help you prepare your materials and allocate time and resources. However, the best way to prepare for a lab audit is to always be ready for an audit. 

Tips for the “audit-ready” laboratory:

1. Make sure your Standard Operating Procedures are up-to-date.
   In order to understand how your lab is processing samples or collecting data, the auditor will be looking for clear SOPs that accurately describe the work in the lab. In general, once SOPs are created, they should be reviewed each year by people doing the work – and edited and versioned appropriately. Keeping your SOPs accessible and accurate will make preparing for an audit less stressful. If you have created corresponding lab workflows, you should also make sure that these accurately reflect your documented procedures.
2. Ensure staff training records are up-to-date, complete and easily accessible. Auditors will check that the staff performing work in the lab are competently trained in the work they are performing. Keep accurate records of staff training and make sure that staff are getting regular refreshers as lab processes are updated.
3. Have audit-ready sample records.
   This can be challenging if your lab doesn’t follow standard procedures for record-keeping, or if your sample management software isn’t already doing this for you. If you’re not sure if your sample management system keeps audit-ready records, start by asking yourself- “If I picked a sample at random, would I be able to identify everything that happened to this sample?” Follow the “Who/What/When” approach – who performed that on what sample when? Sometimes the answer may be yes, but it could be a jumble of assorted records spread between notebooks and electronic systems. If you can’t establish the chain of custody easily and quickly, it may be time to reconsider your sample management system.

LabKey Sample Manager makes complete sample records and chain-of-custody easy to access with our Timeline feature. Timeline shows the complete chain of events for an individual sample from initial registration, to metadata/status updates, all storage events, related assay data and addition of samples to a workflow job. 

>Learn More About LabKey Sample Manager