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# Standard Operating Procedure: Document Control
| Document ID | SOP-001 |
|-------------|---------|
| Title | Document Control |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
## 2. Scope
This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Specifications
- External documents of external origin
## 3. Responsibilities
### 3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
## 4. Procedure
### 4.1 Document Creation
1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Submit for review and approval
### 4.2 Document Review and Approval
1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Final approval by designated approver
5. Quality Assurance releases document
### 4.3 Document Numbering
Documents shall be numbered according to the following convention:
| Type | Prefix | Example |
|------|--------|---------|
| Policy | POL | POL-001 |
| SOP | SOP | SOP-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
### 4.4 Revision Control
1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer
### 4.5 Document Distribution
1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed
### 4.6 Periodic Review
1. Documents reviewed at least every 2 years
2. Review documented even if no changes made
3. Reviews may result in revision or reaffirmation
## 5. Related Documents
- FRM-001 Document Change Request Form
- FRM-002 Document Review Record
## 6. Definitions
| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
| Document ID | SOP-002 |
|-------------|---------|
| Title | Corrective and Preventive Action |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
## 2. Scope
This procedure applies to:
- Product and process nonconformities
- Customer complaints
- Audit findings
- Process deviations
- Potential nonconformities identified through risk analysis
## 3. Definitions
| Term | Definition |
|------|------------|
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
| Root Cause | Fundamental reason for a nonconformity |
| Effectiveness Check | Verification that implemented actions achieved desired results |
## 4. Responsibilities
### 4.1 CAPA Owner
- Investigates the issue
- Identifies root cause
- Develops and implements corrective/preventive actions
- Verifies effectiveness
### 4.2 Quality Assurance
- Manages CAPA system
- Assigns CAPA numbers
- Tracks CAPA status
- Reviews and approves CAPAs
- Reports CAPA metrics to management
### 4.3 Management
- Provides resources for CAPA implementation
- Reviews CAPA trends
- Ensures timely closure
## 5. Procedure
### 5.1 CAPA Initiation
1. Identify nonconformity or potential nonconformity
2. Document issue on CAPA Form (FRM-003)
3. Classify severity and priority
4. Assign CAPA owner
### 5.2 Investigation
1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Use appropriate investigation tools:
- 5 Whys
- Fishbone Diagram
- Failure Mode Analysis
### 5.3 Root Cause Analysis
1. Identify potential root causes
2. Verify root cause through evidence
3. Document root cause determination
4. Consider systemic implications
### 5.4 Action Development
1. Develop corrective/preventive actions
2. Assign responsibilities and due dates
3. Assess actions for:
- Appropriateness to problem severity
- Impact on other processes
- Resource requirements
### 5.5 Implementation
1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide training as needed
### 5.6 Effectiveness Verification
1. Define effectiveness criteria
2. Allow sufficient time for actions to take effect
3. Collect and analyze data
4. Document verification results
5. If ineffective, reopen CAPA for further action
### 5.7 Closure
1. Review all CAPA documentation
2. Verify all actions completed
3. Confirm effectiveness verified
4. Obtain approval for closure
## 6. CAPA Metrics
Quality Assurance shall track and report:
- Number of open CAPAs
- CAPA aging
- On-time closure rate
- Effectiveness rate
- CAPAs by category/source
## 7. Related Documents
- FRM-003 CAPA Form
- SOP-003 Nonconforming Product Control
- SOP-004 Customer Complaints
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Training and Competence
| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |
---
## 1. Purpose
To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
## 2. Scope
This procedure applies to:
- All employees performing quality-affecting activities
- Contractors and temporary personnel
- Personnel requiring GxP training
## 3. Responsibilities
### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure training is completed before performing tasks
- Evaluate competence of personnel
- Maintain department training records
### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Archive training records
### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for GxP activities
- Audit training compliance
### 3.4 Employees
- Complete assigned training on time
- Maintain current qualifications
- Report training needs to supervisor
## 4. Procedure
### 4.1 Training Needs Assessment
1. Identify competence requirements for each role
2. Document requirements in job descriptions
3. Assess current competence of personnel
4. Identify training gaps
### 4.2 Training Curriculum Development
1. Define learning objectives
2. Develop training materials
3. Identify delivery method:
- Classroom
- On-the-job
- Self-study
- Computer-based
4. Define assessment criteria
5. Obtain approval from Quality (for GxP training)
### 4.3 Training Delivery
1. Schedule training session
2. Document attendance
3. Deliver training per curriculum
4. Assess comprehension through:
- Written test (minimum 80% passing)
- Practical demonstration
- Supervisor observation
### 4.4 Training Documentation
Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results
- Signatures
### 4.5 Retraining Requirements
Retraining is required when:
- Significant document revisions occur
- Performance deficiencies identified
- Extended absence from job function
- Periodic requalification due
### 4.6 New Employee Orientation
All new employees shall complete:
1. Company orientation
2. Quality system overview
3. Job-specific training
4. SOP read and understand for applicable procedures
## 5. Training Records Retention
- Training records maintained for duration of employment
- Records retained 3 years after employee departure
- Records available for regulatory inspection
## 6. Related Documents
- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- Job Descriptions
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Internal Audit
| Document ID | SOP-004 |
|-------------|---------|
| Title | Internal Audit |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
## 2. Scope
This procedure covers:
- QMS process audits
- Compliance audits
- Product audits
- System audits
## 3. Definitions
| Term | Definition |
|------|------------|
| Audit | Systematic, independent examination to determine conformance |
| Auditor | Person qualified to perform audits |
| Finding | Observation of conformance or nonconformance |
| Observation | Noted item not rising to level of finding |
## 4. Responsibilities
### 4.1 Lead Auditor
- Plans and schedules audits
- Prepares audit checklists
- Conducts audit activities
- Reports audit findings
### 4.2 Quality Manager
- Maintains audit program
- Qualifies auditors
- Reviews audit reports
- Reports to management
### 4.3 Auditee
- Provides access to areas/records
- Responds to findings
- Implements corrective actions
## 5. Procedure
### 5.1 Annual Audit Schedule
1. Develop annual audit schedule considering:
- Previous audit results
- Process criticality
- Regulatory requirements
- Changes to processes
2. Ensure all QMS processes audited at least annually
3. Obtain management approval
4. Communicate schedule to affected areas
### 5.2 Auditor Qualification
Auditors shall:
- Complete auditor training course
- Conduct at least 2 audits under supervision
- Be independent of area being audited
- Maintain competence through ongoing audits
### 5.3 Audit Preparation
1. Review applicable procedures and standards
2. Review previous audit reports
3. Prepare audit checklist
4. Notify auditee of audit scope and schedule
5. Confirm auditor availability
### 5.4 Conducting the Audit
1. Hold opening meeting with auditee
2. Execute audit checklist
3. Gather objective evidence:
- Document review
- Personnel interviews
- Process observation
4. Document findings with evidence
5. Classify findings:
- Major Nonconformance
- Minor Nonconformance
- Observation
6. Hold closing meeting
### 5.5 Audit Reporting
1. Complete audit report within 5 business days
2. Report shall include:
- Audit scope and criteria
- Personnel interviewed
- Findings with evidence
- Recommendations
3. Distribute report to auditee and management
### 5.6 Finding Resolution
1. Auditee responds with corrective action plan within 10 business days
2. Quality reviews and approves plan
3. Auditee implements corrective actions
4. Auditor verifies effectiveness
5. Close finding upon verification
## 6. Audit Records
Maintain for 5 years:
- Audit schedules
- Checklists
- Reports
- Corrective action records
## 7. Related Documents
- FRM-006 Audit Checklist Template
- FRM-007 Audit Report Template
- SOP-002 CAPA
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Management Review
| Document ID | SOP-005 |
|-------------|---------|
| Title | Management Review |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
## 2. Scope
This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
## 3. Frequency
Management reviews shall be conducted:
- At least annually
- More frequently if significant changes occur
- As needed based on quality performance
## 4. Responsibilities
### 4.1 Quality Manager
- Prepares management review agenda and materials
- Facilitates the meeting
- Documents meeting minutes and action items
- Tracks completion of action items
### 4.2 Top Management
- Attends management review meetings
- Reviews QMS performance data
- Makes decisions on QMS improvements
- Allocates resources as needed
### 4.3 Department Managers
- Provides input data for their areas
- Attends management review
- Implements assigned action items
## 5. Management Review Inputs
The following shall be considered:
### 5.1 Actions from Previous Reviews
- Status of action items
- Effectiveness of implemented actions
### 5.2 Changes in Context
- Internal changes (organization, resources)
- External changes (regulations, market)
### 5.3 QMS Performance
- Customer satisfaction and feedback
- Quality objectives achievement
- Process performance metrics
- Nonconformities and corrective actions
- Audit results
- Supplier performance
### 5.4 Resource Adequacy
- Personnel
- Infrastructure
- Work environment
### 5.5 Risk and Opportunities
- Risk assessment results
- Effectiveness of risk controls
- New opportunities identified
### 5.6 Improvement Opportunities
- Process improvements
- Product improvements
- QMS enhancements
## 6. Management Review Outputs
Decisions and actions related to:
- Improvement of QMS and processes
- Product improvement
- Resource needs
- Changes to quality policy or objectives
## 7. Documentation
### 7.1 Meeting Minutes
- Date and attendees
- Items discussed
- Decisions made
- Action items with owners and due dates
### 7.2 Record Retention
- Management review records retained for 5 years
- Available for regulatory inspection
## 8. Related Documents
- FRM-008 Management Review Agenda Template
- FRM-009 Management Review Minutes Template
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: TMS Treatment Protocol
| Document ID | SOP-TMS-001 |
|-------------|-------------|
| Title | Transcranial Magnetic Stimulation Treatment Protocol |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | TMS Clinic |
---
## 1. Purpose
To establish standardized procedures for the safe and effective administration of Transcranial Magnetic Stimulation (TMS) therapy in accordance with FDA clearances, manufacturer guidelines, and clinical best practices.
## 2. Scope
This procedure applies to all TMS treatments including:
- Repetitive TMS (rTMS) for Major Depressive Disorder
- rTMS for Obsessive-Compulsive Disorder
- Intermittent Theta Burst Stimulation (iTBS)
- Other FDA-cleared or investigational protocols
## 3. Responsibilities
### 3.1 TMS Technician/Operator
- Position patient and equipment
- Determine motor threshold
- Administer treatment per prescription
- Monitor patient during treatment
- Document treatment parameters
### 3.2 Prescribing Physician
- Evaluate patient eligibility
- Prescribe treatment protocol
- Review progress and adjust treatment
- Manage adverse events
- Provide medical oversight
### 3.3 Clinical Coordinator
- Schedule treatments
- Track treatment compliance
- Coordinate patient assessments
- Maintain equipment logs
## 4. Definitions
| Term | Definition |
|------|------------|
| MT | Motor Threshold - minimum intensity to produce MEP |
| MEP | Motor Evoked Potential - observable motor response |
| rTMS | Repetitive Transcranial Magnetic Stimulation |
| iTBS | Intermittent Theta Burst Stimulation |
| DLPFC | Dorsolateral Prefrontal Cortex - common target for depression |
## 5. Equipment and Materials
- TMS device (FDA-cleared)
- Treatment coil (figure-8 or appropriate for indication)
- Positioning chair or table
- Ear protection (ear plugs)
- Treatment cap or head marking system
- Motor threshold determination tools
- Emergency equipment (as per emergency SOP)
## 6. Procedure
### 6.1 Pre-Treatment Assessment
#### 6.1.1 Initial Evaluation (First Treatment)
1. **Verify Prescription**
- Diagnosis confirmed
- Treatment protocol specified
- Contraindications reviewed
- Informed consent on file
2. **Safety Screening**
Confirm absence of contraindications:
- [ ] No ferromagnetic metal in head/neck
- [ ] No implanted devices (pacemaker, cochlear implant, DBS)
- [ ] No history of seizures (unless per protocol)
- [ ] No unstable medical conditions
- [ ] Current medications reviewed for seizure threshold effects
- [ ] Pregnancy test negative (if applicable)
3. **Baseline Assessments**
- PHQ-9 or HAM-D (depression)
- Y-BOCS (OCD, if applicable)
- Vital signs
- Cognitive baseline if indicated
#### 6.1.2 Daily Pre-Treatment Check
Before each session:
- [ ] Patient identity verified
- [ ] Assess for new contraindications
- [ ] Confirm adequate sleep (>4 hours)
- [ ] Confirm no alcohol/illicit substances
- [ ] Confirm no significant medication changes
- [ ] Assess for current illness
- [ ] Review previous session tolerance
### 6.2 Motor Threshold Determination
**Required at:**
- First treatment session
- Any significant change in medications affecting neural excitability
- If treatment efficacy changes significantly
- Per physician order
**Procedure:**
1. Position patient comfortably
2. Place coil over motor cortex (M1) contralateral to dominant hand
3. Begin at 30-40% machine output
4. Deliver single pulses at 10-second intervals
5. Observe for thumb/finger movement (APB)
6. Increase intensity by 5% increments
7. Record lowest intensity producing 5 MEPs in 10 trials
8. Document MT and method used
| MT Parameter | Value |
|--------------|-------|
| Date | |
| Resting Motor Threshold (%) | |
| Target Muscle | |
| Number of Trials | |
| Determined By | |
### 6.3 Treatment Coil Positioning
#### 6.3.1 Left DLPFC Targeting (Standard Depression Protocol)
**5-cm Rule Method:**
1. Identify motor hotspot (from MT determination)
2. Measure 5 cm anteriorly along scalp surface
3. Mark position on treatment cap
4. Verify coil angle (45° to midline)
**Neuronavigation Method (if available):**
1. Register patient to MRI
2. Identify target coordinates
3. Position coil using navigation system
4. Document coordinates and trajectory
#### 6.3.2 Alternative Targets
- Right DLPFC (low-frequency protocol)
- Supplementary Motor Area (OCD)
- Other per protocol specification
### 6.4 Treatment Administration
1. **Patient Preparation**
- Seat in treatment chair
- Provide ear protection
- Position head comfortably
- Instruct patient on what to expect
2. **Equipment Setup**
- Power on device and perform calibration
- Select prescribed protocol
- Set treatment parameters:
| Parameter | Value |
|-----------|-------|
| Frequency (Hz) | |
| Intensity (% MT) | |
| Pulses per train | |
| Inter-train interval | |
| Total pulses | |
| Duration | |
3. **Treatment Delivery**
- Position coil at marked location
- Maintain consistent coil contact
- Begin treatment delivery
- Monitor patient continuously
- Pause if patient reports concerning symptoms
4. **Patient Monitoring During Treatment**
Observe for:
- Facial twitching (may indicate coil drift)
- Signs of distress
- Seizure warning signs
- Excessive discomfort
### 6.5 Standard Treatment Protocols
#### Major Depressive Disorder - Standard rTMS
| Parameter | Left DLPFC |
|-----------|------------|
| Frequency | 10 Hz |
| Intensity | 120% MT |
| Train duration | 4 seconds |
| Inter-train interval | 26 seconds |
| Trains per session | 75 |
| Total pulses | 3,000 |
| Session duration | ~37.5 minutes |
| Total sessions | 30-36 |
#### Major Depressive Disorder - iTBS
| Parameter | Left DLPFC |
|-----------|------------|
| Pattern | 50 Hz bursts at 5 Hz |
| Intensity | 120% MT |
| Bursts per train | 10 (30 pulses) |
| Inter-train interval | 8 seconds |
| Total pulses | 600 |
| Session duration | ~3 minutes |
| Total sessions | 30-36 |
### 6.6 Post-Treatment
1. **Immediate Assessment**
- Ask about side effects
- Assess for headache, scalp pain
- Evaluate mental status
- Confirm safe to leave
2. **Documentation**
Complete FRM-TMS-001 Treatment Log:
- Date and session number
- Treatment parameters used
- Coil position
- Patient tolerance
- Any adverse effects
- Operator signature
3. **Patient Instructions**
- Mild headache/scalp discomfort common
- OTC analgesics acceptable
- Report severe/persistent symptoms
- Confirm next appointment
### 6.7 Adverse Event Management
| Event | Severity | Action |
|-------|----------|--------|
| Scalp discomfort | Mild | Adjust position, OTC analgesic |
| Headache | Mild-Moderate | OTC analgesic, reduce intensity if persistent |
| Syncope | Moderate | Stop treatment, lie patient down, assess vitals |
| Seizure | Severe | Stop treatment, protect patient, follow seizure protocol |
**Seizure Response:**
1. Stop stimulation immediately
2. Note time
3. Protect patient from injury
4. Do not restrain
5. Call for help / activate emergency protocol
6. Monitor airway and breathing
7. Time seizure duration
8. Notify physician immediately
9. Complete incident report
## 7. Outcome Monitoring
| Assessment | Timing | Tool |
|------------|--------|------|
| Depression severity | Weekly | PHQ-9 or HAM-D |
| OCD severity (if applicable) | Weekly | Y-BOCS |
| Side effects | Each session | TMS side effect checklist |
| Treatment response | Sessions 10, 20, 30 | Physician evaluation |
| Remission assessment | End of acute course | Full clinical evaluation |
## 8. Documentation
- FRM-TMS-001 TMS Treatment Log
- FRM-TMS-002 Motor Threshold Record
- FRM-TMS-003 Side Effect Checklist
- Outcome assessment forms
- Equipment maintenance logs
## 9. References
- FDA clearance documentation
- Manufacturer operating manual
- Clinical practice guidelines (APA, CANMAT)
- Peer-reviewed TMS literature
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |