Creating Subjects

Subjects in VariantMiner represent the individuals (patients) from whom biological samples are collected for genetic analysis. This guide walks you through creating and managing subject records.

What is a Subject?

A subject is a patient or individual record that contains:

  • Demographics: Name, date of birth, gender, ethnicity

  • Medical Information: Clinical history, phenotype, diagnosis

  • Family Information: Family relationships and pedigree data

  • Consent Status: Testing consent and permissions

  • Sample Associations: Links to biological samples

Creating a New Subject

From the Subjects Dashboard

  1. Navigate to Subjects

    • Click "Subjects" in the main navigation

    • You'll see the subjects dashboard for your current workspace

Subjects DashboardThe subjects dashboard showing list of subjects and creation options

  1. Start Subject Creation

    • Click "Create New Subject" button

    • Subject creation form opens

  2. Enter Basic Information

    • Subject ID: Unique identifier (auto-generated or custom)

    • First Name: Patient's first name

    • Last Name: Patient's last name

    • Date of Birth: Patient's birth date

    • Gender: Male, Female, or Other

    • Ethnicity: Ethnic background (optional)

From Sample Creation

When creating samples, you can create subjects on-the-fly:

  1. During Sample Creation

    • In the sample creation form

    • Select "Create New Subject" option

    • Enter subject information inline

    • Subject is created and linked to the sample

From Order Wizard

The Order Creation Wizard allows subject creation:

  1. During Order Setup

    • When configuring samples

    • Choose "Create New Subject"

    • Enter subject details

    • Subject is created and associated with the order

Subject Information Fields

Required Fields

  • Subject ID: Unique identifier within the workspace

  • First Name: Patient's given name

  • Last Name: Patient's family name

  • Date of Birth: For age calculation and identification

Optional Fields

  • Middle Name: Additional name information

  • Gender: Biological sex or gender identity

  • Ethnicity: Ethnic/racial background

  • Medical Record Number: Hospital or clinic MRN

  • External ID: ID from external systems (LIMS, EMR)

Clinical Information

  • Primary Diagnosis: Main clinical diagnosis

  • Clinical Notes: Additional clinical information

  • Phenotype: Observable characteristics

  • Family History: Relevant family medical history

  • Previous Testing: Prior genetic testing results

Contact Information

  • Phone Number: Contact phone (if consented)

  • Email Address: Contact email (if consented)

  • Address: Mailing address (if needed)

  • Emergency Contact: Emergency contact information

Subject ID Management

Auto-Generated IDs

  • System generates unique IDs automatically

  • Format: SUB_YYYYMMDD_001, SUB_YYYYMMDD_002, etc.

  • Ensures uniqueness within workspace

  • Can be customized by administrators

Custom IDs

  • Enter your own subject identifier

  • Must be unique within workspace

  • Follow institutional naming conventions

  • Common formats: Patient ID, MRN, study ID

ID Validation

  • System checks for duplicates

  • Prevents ID conflicts

  • Validates format requirements

  • Warns about potential issues

Clinical Information

Diagnosis and Phenotype

Enter relevant clinical information:

Primary Diagnosis:

Example: "Hypertrophic cardiomyopathy"

Clinical Notes:

Example: "36-year-old male with family history of sudden 
cardiac death. Presents with chest pain and dyspnea on 
exertion. Echo shows LV wall thickness 18mm."

Phenotype (HPO terms preferred):

Examples:
- HP:0001639 (Hypertrophic cardiomyopathy)
- HP:0001645 (Sudden cardiac death)
- HP:0002094 (Dyspnea)

Family History

Document relevant family medical history:

Structured Format:

  • Father: Deceased age 45, sudden cardiac death

  • Mother: Alive, hypertension

  • Sibling 1: Alive, no known cardiac issues

  • Maternal grandfather: Deceased, heart attack age 60

Previous Testing

Record any prior genetic testing:

Test History:

  • Date: 2023-01-15

  • Test: Cardiomyopathy panel

  • Laboratory: External Lab Inc.

  • Results: No pathogenic variants identified

  • Notes: Limited panel, 50 genes tested

Data Privacy

  • Subject data is protected and encrypted

  • Access controlled by workspace permissions

  • Activity logging tracks all access

  • Comply with institutional privacy policies

Track consent status for:

  • Genetic Testing: Consent for current analysis

  • Data Storage: Long-term data retention

  • Research Use: Use of data for research

  • Data Sharing: Sharing with external parties

  • Re-contact: Permission to contact with results

De-identification

For research use:

  • Remove or encrypt identifying information

  • Use study-specific IDs

  • Follow IRB requirements

  • Maintain mapping separately if needed

Family Relationships

Pedigree Information

Link related subjects:

Family Structure:

  • Proband: Primary affected individual

  • Parents: Mother and father

  • Siblings: Brothers and sisters

  • Children: Offspring

  • Extended Family: Grandparents, aunts, uncles

Create family connections:

  1. During Subject Creation

    • Select existing family members

    • Define relationship type

    • System creates bidirectional links

  2. After Subject Creation

    • Edit subject record

    • Add family relationships

    • Search for existing subjects

Inheritance Patterns

Document expected inheritance:

  • Autosomal Dominant: Vertical transmission

  • Autosomal Recessive: Horizontal pattern

  • X-linked: Male predominance

  • Mitochondrial: Maternal inheritance

  • De novo: New mutation

Subject Management

Editing Subject Information

To modify subject records:

  1. Find the Subject

    • Navigate to Subjects dashboard

    • Search by name or ID

    • Click on subject name

  2. Edit Information

    • Click "Edit Subject" button

    • Modify fields as needed

    • Add clinical notes or update diagnosis

  3. Save Changes

    • Click "Save" to persist changes

    • Changes are logged for audit trail

    • Notifications sent if configured

Merging Subjects

If duplicate subjects exist:

  1. Identify Duplicates

    • System may flag potential duplicates

    • Manual review and confirmation required

  2. Merge Process

    • Select primary subject record

    • Choose information to keep/merge

    • System combines associated samples and data

  3. Verify Merge

    • Review merged record for accuracy

    • Check associated samples and orders

    • Update any references as needed

Deleting Subjects

Subject deletion has restrictions:

When Deletion is Allowed:

  • No associated samples

  • No associated orders or reports

  • No family relationships

  • User has appropriate permissions

When Deletion is Blocked:

  • Active samples exist

  • Orders reference the subject

  • Reports include the subject

  • Family relationships exist

Integration with Samples

Linking Samples

Subjects are connected to samples:

Automatic Linking:

  • During sample creation

  • Subject is selected or created

  • Bidirectional relationship established

Manual Linking:

  • Edit existing sample

  • Change or add subject association

  • System validates the relationship

Sample Overview

In subject details, view:

  • All associated samples

  • Sample types (blood, tissue, etc.)

  • Collection dates

  • Processing status

  • File associations

Best Practices

Data Quality

  • Consistent Naming: Follow naming conventions

  • Complete Information: Fill in all relevant fields

  • Accurate Demographics: Verify personal information

  • Clinical Relevance: Include pertinent clinical data

Privacy Protection

  • Minimal Information: Collect only necessary data

  • Secure Storage: Use encrypted, secure systems

  • Access Control: Limit access to authorized users

  • Audit Trails: Monitor all data access

Documentation

  • Clinical Notes: Document relevant clinical information

  • Test History: Record previous testing

  • Family History: Include relevant family medical history

  • Consent Status: Track all consent permissions


Subject created successfully? Continue to Managing Samples to learn about linking biological samples to subjects.

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