When adopting LabArchives in clinical research, questions often arise about managing sensitive data, including Protected Health Information (PHI). Institutional policies vary—some allow LabArchives to store all PHI, while others restrict it to de-identified data only. Because of these differences, researchers should consult their institution’s IT, compliance, or research leadership for clear guidance.
LabArchives supports secure documentation through encrypted backups, isolated databases, and detailed access controls. It has passed security and compliance audits from many research institutions. For more details, visit the Trust, Security & Compliance page.
Supporting Clinical Research Workflows
LabArchives supports many types of clinical research beyond traditional lab-based work. It helps research teams stay organized, compliant, and collaborative throughout the study lifecycle.
Common Use Cases:
- Clinical Trials: Store protocols, consent forms, visit schedules, and outcome measures. Use folders and permissions to separate blinded and unblinded data.
- Chart Reviews: Keep de-identified notes, data abstraction tools, and reviewer logs in one place.
- Survey Studies: Save survey forms, recruitment logs, and links to tools like REDCap. Use templates to keep documentation consistent.
- Multi-Site Studies: Collaborate across institutions with shared notebooks. Track meetings, milestones, and updates in real time.
- Quality Improvement (QI) Projects: Document workflows, interventions, and results for clinical QI efforts.
Templates and widgets can help standardize processes across sites and teams.
- Templates: Preformat pages for common uses like visit logs, chart reviews, or protocol checklists.
- Widgets: Create simple forms with dropdowns, checkboxes, and date fields for structured data entry.
Referencing External Data Systems & Managing Coded Data
LabArchives is not always the primary location for sensitive clinical data—but it works well for documenting and referencing systems that are:
- Use Rich Text Entries to document links or file paths to external systems like REDCap, institutional drives, or EHR systems. When applicable, you may also use the Linking tool to reference related content
- Clearly describe the referenced data (e.g., “REDCap Survey Results – Cohort A”).
- Avoid including PHI or direct identifiers unless explicitly permitted by institutional policy.
Coded Data and Key Sheets
For studies using coded data:
- Assign unique IDs to each participant or sample to remove identifiable information.
- Do not store identifiable information (like names or medical record numbers) in the same LabArchives notebook as the key that links participant IDs to identities. Keep the key sheet in a separate, secure location with limited access.
- Only authorized personnel should have access to the linkage file.
This helps protect participant privacy and supports IRB and HIPAA compliance.
Access Controls, Collaboration, and Compliance
LabArchives makes it easy to manage access, share work, and maintain regulatory standards:
- Access Roles: Assign members view-only, editing, or no-access permissions based on their role.
- Blinded Studies: Restrict access to randomization or treatment arms to protect study integrity.
- Audit Trail: All activity is tracked with time stamps and user logs, supporting transparency and reproducibility.
- Multi-Site Projects: Collaborators across institutions can be granted controlled access to specific pages or folders.
These features help manage large teams and complex studies while protecting sensitive data.
Project and Document Management
LabArchives is more than a research notebook—it can be used to manage projects, meetings, and publications:
- Meeting Notes: Document agendas, discussion points, and action items.
- Onboarding & SOPs: Centralize team documents like IRB approvals, protocols, training materials, and checklists.
- Manuscripts: Create folders for each publication to store drafts, revisions, reviewer feedback, and related materials.
- Task Tracking: Assign and monitor tasks directly in shared pages or using templates.
This keeps all project-related content in one place, easily accessible to your team.
REDCap Integration
LabArchives integrates with REDCap, allowing you to:
- Export reports from REDCap directly into a LabArchives notebook.
- Annotate or link REDCap results to protocols, meetings, or analysis summaries.
- Build a complete study record, even when sensitive data remains securely stored elsewhere.