Biosample Management System: Official User Manual
Project 855303
1. Introduction
Welcome to the Biosample Management System, a web-based application designed to streamline the management of biosample collection, inventory, and shipment. This manual serves as a comprehensive guide for lab technicians and data entry personnel, providing detailed instructions for all key modules and features.
2. System Overview & Data Dictionary
The system is built on a relational database to ensure data integrity and traceability. The following tables contain the core information for all application functions.
Database Tables (Data Dictionary)
- sys_master_menus: Defines the main menu structure and permissions.
- sys_object: Stores unique object types within the system.
- sys_object_properties: Holds detailed properties and values for each object.
- sys_object_relationship: Documents parent-child relationships between objects.
- sys_request_track: Logs all user requests for auditing and troubleshooting.
- sys_srv_idents: Tracks active user sessions and authentication.
- sys_system_access_log: Logs user login, logout, and other system access activities.
- ut_help_tickets: Stores user-submitted help tickets.
- ut_manifests: Records all created shipment manifests.
- ut_manifests_properties: Stores details and properties for each manifest.
- ut_qry_inventory: Logs all user inventory search queries.
- ut_sample_obj: Stores records for each collected sample.
- ut_sample_properties: Holds properties and values for each sample.
- ut_sop_deviations: Documents all deviations from standard operating procedures.
- ut_subject_obj: Stores records for each subject.
- ut_subject_properties: Holds properties and values for each subject.
- worddictionary: A system dictionary for standardized terms and definitions.
3. Key Modules & Workflows
3.1 Sample Entry
The Sample Entry screen is used to log new biosample collection data. This module is designed to guide you through a step-by-step data entry process for a new sample.
Dialog Boxes
Deviation Report Dialog: This dialog box is automatically triggered when a user selects a value of "1" for the Tubes Collected field. It requires the user to document the reason for the deviation.
- Deviation Reason: A mandatory free-text field for explaining why fewer than the required tubes were collected.
- Submit: Saves the deviation reason and allows the user to continue with data entry.
- Cancel: Closes the dialog without saving, requiring the user to re-enter the Tubes Collected field.
3.2 Shipping Samples
The Shipping Samples module is used to prepare and document the shipment of biosamples to the CHTN Eastern Laboratories.
Procedure
- Locate Samples: Use the query fields to search for samples by Subject Number, Accession Number, or Draw Date. Leaving all fields blank will display all non-shipped and non-voided samples ready for shipment.
- Select Samples: Click on the data row of each sample you intend to ship. The row will turn green, indicating it has been selected.
- Review Shipping Rules: Before proceeding, ensure you adhere to the following rules:
- Only ship one tube from a tube pair per shipment. A sample with the status "Sample Partially Shipped" means its paired tube has already been shipped.
- Contact the CHTN Eastern Laboratories for shipping authorization before creating a manifest.
- The Subject Consent status for all samples must be 'Yes'.
- Each manifest has a maximum capacity of 48 samples.
- Enter Shipment Details: In the Saved Fields section, fill in the following:
- Shipment Date: Required field for the date of shipment.
- Temp-Tale Activated: Defaults to 'YES.' Change to 'NO' if the temperature monitor was not activated.
- Ship-Tracking Number: Required field for the package's tracking number.
- Shipping Notes: A field for any additional information. Do not include HIPAA data.
- Submit: Click the Ship button to create a manifest and mark the selected samples as shipped.
3.3 Sample Inventory Management
The Sample Inventory Management module is a central hub for querying, viewing, and managing existing sample records.
Procedure
- Query the Database: Use the query fields (Subject Number, Visit Number, Draw Date, Subject Sex, Manifest Number, Shipment Date) and click "Run Query" to find samples. Leaving all fields blank will display all records.
- View Search Results: The results table shows key sample details. You can click on blue links and buttons to access actionable dialogs.
- Manifest Number Link: Opens the Manifest View dialog, showing a summary of a specific shipment and allowing you to reprint the manifest.
- Status Link: Opens the Segment Statuser dialog, where you can change a sample's status. Changes require a reason and attestation.
- Consent Link: Opens the Participant Consent Updater dialog, which allows you to change a subject's consent status. This is a critical action that requires a reason.
- Reporting and Exporting:
- Share Link: Opens a dialog to email a link to your current query results.
- Print Results: Generates a printable PDF report of your query results.
- Export Results: Exports the query results to a file for use in a spreadsheet program.
4. Appendix
- System Support: For technical assistance, please contact...
- Training Materials: This manual is a companion to the official training videos. You can find them at...