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Project Locking Impact on Tasks Manager

Overview

Project locking makes task-related data read-only to preserve data integrity during study closeout, regulatory submission, or audit activities. When a project is locked, all task management functionality, form responses, annotations, and protocol usage become immutable, ensuring that clinical trial data remains in its final state.

This document describes how project locking affects tasks, protocols, and form data in the Tasks Manager system. For instructions on how to lock and unlock projects, see Project Locking Process.

Understanding these impacts helps study coordinators plan project locking timing and ensures readers know what functionality is available when working with locked projects.

How Project Locking Affects Tasks

When a project is locked, task-related functionality becomes read-only to preserve data integrity.

Tasks Become Immutable

What You Cannot Do:

  • Create new tasks: Assigners cannot create tasks in locked projects
  • Edit task details: Cannot modify task descriptions, due dates, priorities, or tags
  • Reassign tasks: Cannot change task assignments or move tasks to different users or pools
  • Cancel tasks: Cannot change task status, including canceling in-progress or to-do tasks

What You Can Do:

  • View task lists: All users with appropriate permissions can view tasks in locked projects
  • View task details: Task metadata, assignments, and status information remain accessible
  • Export task data: Task lists and details can be exported for reporting and analysis

Form Responses Are Read-Only

What You Cannot Do:

  • Submit new form responses: Cannot complete tasks or submit forms in locked projects
  • Edit completed forms: Cannot modify any field values in submitted forms
  • Delete form responses: Cannot remove form data from completed tasks

What You Can Do:

  • View form responses: All completed form data is accessible in read-only mode
  • Export form data: Form responses can be exported to CSV, Excel, or other formats
  • Generate reports: Form data is available for analysis and reporting

Annotations Cannot Be Modified

What You Cannot Do:

  • Create new annotations: Cannot add annotations to tasks in locked projects
  • Edit existing annotations: Cannot modify measurement values, labels, or coordinates
  • Delete annotations: Cannot remove annotations from completed tasks
  • Edit drafts: Even draft annotations in in-progress tasks cannot be modified

What You Can Do:

  • View annotations: All annotations remain visible in the V3 Viewer in read-only mode
  • Export annotations: Annotation data can be exported for analysis
  • Review measurements: Measurement values and labels are accessible for verification

Protocol Usage Restrictions

Protocols Themselves Are Not Affected:

  • Protocols are managed at the group level, not the project level
  • Locking a project does not lock or archive protocols
  • Other projects in the group can continue using the same protocols

Protocol Usage in Locked Projects:

  • Cannot create new tasks using any protocol in locked projects
  • Existing tasks continue to reference their assigned protocol versions
  • Protocol version information remains accessible for audit trail purposes

Visual Indicators

Locked Project Badge:

  • Locked projects display a lock icon or badge in the project list
  • The project details page shows lock status prominently
  • Warning messages appear if you attempt restricted actions

Locked Task Indicators:

  • Tasks in locked projects display a lock indicator
  • Task detail pages show that the project is locked
  • Action buttons are disabled or hidden when the project is locked

When Projects Are Locked

Project locking is typically applied during:

  • Study data collection is complete: All tasks are finished and no further data entry is expected
  • Preparing for data analysis: Lock data before final analysis to ensure analysis is performed on stable data
  • Regulatory submission preparation: Lock projects before generating submission packages
  • Study closeout: Lock projects as part of final study closeout procedures
  • Audit preparation: Lock data before internal or external audits to prevent changes during audit period

Administrative Action

Project locking requires administrative permissions and is performed by project or site administrators. For detailed instructions on the locking process, see Project Locking Process.

Working with Locked Projects

Users can continue to access and analyze data in locked projects, but cannot make any modifications.

Viewing Tasks and Data

What You Can Access:

  • Task lists: View all tasks in the project, filter and sort as needed
  • Task details: Open task details to review metadata, assignments, and status
  • Form responses: View all completed form data in read-only mode
  • Annotations: View annotations in the V3 Viewer (read-only mode)
  • Audit trail: Access audit trail entries for tasks (if Validated Instance is enabled)

Navigation and Search:

  • Use task filters to find specific tasks
  • Search by task ID, container, assignee, or other criteria
  • Export task lists for offline review or analysis

Completing Tasks in Locked Projects

Cannot Start New Tasks:

  • Tasks in "To-Do" status cannot be started
  • The viewer does not open for to-do tasks in locked projects
  • Assignees cannot claim tasks from staffing pools

Cannot Continue In-Progress Tasks:

  • Tasks in "In Progress" status cannot be continued
  • Draft form responses and annotations cannot be edited
  • The viewer opens in read-only mode (or does not open) for in-progress tasks

Can View Completed Tasks:

  • Completed tasks open in read-only mode
  • All form responses and annotations are visible
  • No edits are possible

In-Progress Tasks Are Frozen

Any tasks that were in progress when the project was locked remain in that state. Assignees cannot complete these tasks while the project is locked. Plan project locking carefully to ensure all critical tasks are completed first.

Exporting and Reporting

Data Export Is Allowed:

  • Generate and export task lists
  • Export form response data to CSV or Excel
  • Export annotation data for analysis
  • Generate audit trail reports (if Validated Instance is enabled)

Analysis and Visualization:

  • View data in Flywheel's data visualization tools
  • Access imaging data in the V3 Viewer (read-only)
  • Run read-only queries and reports

Deleting Data

Deletion Is Prohibited:

  • Cannot delete tasks
  • Cannot delete form responses
  • Cannot delete annotations
  • Cannot delete containers with associated tasks

Project locking prevents all destructive operations to ensure data integrity.

After Project Unlocking

If a project is unlocked after being locked:

Restored Functionality:

  • All task creation and editing functionality is restored
  • Assignees can start and complete tasks
  • Assigners can create new tasks
  • Form responses and annotations can be edited (only for in-progress tasks)

Documentation Requirements:

  • Project unlock/relock cycles should be documented in study records
  • The reason for unlocking and who authorized it should be recorded
  • This documentation supports audit trail integrity

For detailed instructions on unlocking projects, see Project Locking Process.

Compliance Implications

Project locking supports multiple compliance and data integrity objectives.

Data Integrity

Prevents Accidental Changes:

  • Users cannot inadvertently modify completed tasks
  • Data remains stable during analysis and reporting
  • Eliminates risk of changes after final review

Ensures Data Consistency:

  • Locked data cannot be altered, ensuring consistency between reports generated at different times
  • Regulatory submissions accurately reflect the locked study data
  • Auditors can verify data has not changed since study completion

Regulatory Compliance

21 CFR Part 11 Support:

  • Project locking demonstrates controls preventing unauthorized data modification
  • Supports 21 CFR Part 11 ยง11.10(k) requirements for data integrity controls
  • Lock/unlock events are logged in the audit trail (if Validated Instance is enabled)

Good Clinical Practice (GCP):

  • Locked projects support GCP requirements for data integrity and quality
  • Prevents post-hoc data manipulation
  • Provides assurance that study results accurately reflect collected data

Regulatory Submission Readiness:

  • Locked projects ensure submitted data matches analyzed data
  • Regulators can verify data stability through lock status and audit trail
  • Supports data integrity questions during regulatory review

Study Closeout

Formal Study Completion:

  • Project locking marks formal completion of data collection
  • Clear transition from active data collection to analysis phase
  • Supports study timeline and milestone documentation

Data Handoff:

  • Locked projects can be handed off to analysis teams, statisticians, or regulatory affairs
  • Recipients have confidence that data will not change during their work
  • Simplifies coordination between data collection and analysis teams

Audit Preparation

Audit Readiness:

  • Locked projects ensure data remains stable during audits
  • Auditors can review data with confidence it has not changed since initial review
  • Supports efficient audit processes by eliminating need to re-verify data

Internal Quality Reviews:

  • Lock projects before internal quality reviews to ensure review results remain valid
  • Prevents changes between review and corrective action implementation
  • Supports quality management system documentation