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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
      • Specific procedures
        • T-TF-028-001 AI Description
        • T-TF-028-002 AI Development Plan
        • T-TF-028-003 Data Collection Instructions
        • T-TF-028-004 Data Annotation Instructions
        • T-TF-028-005 AI Development Report
        • T-TF-028-006 AI Release Report
        • T-TF-028-007 AI Retraining Report
        • T-TF-028-008 AI Reevaluation Report
        • T-TF-028-009 AI Design Checks
        • T-TF-028-010 AI V&V Checks
        • T-TF-028-011 AI Risk Assessment
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
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  • Pricing
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  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-003 Data Collection Instructions

T-TF-028-003 Data Collection Instructions

Table of contents
  • Purpose and Scope
  • Context and Rationale
  • Objectives
  • Data Sources
    • Source Types
    • Source Selection Criteria
    • Source Documentation
  • Data Population Characteristics
    • Recruitment Strategy
    • Participating Institutions (if applicable)
    • Ethical and Legal Considerations
      • Ethical Approval
      • Informed Consent
      • Data Protection and Privacy (GDPR Compliance)
      • Data Processing Agreements
    • Inclusion Criteria
    • Exclusion Criteria
  • Study Design (if applicable)
    • Study Design Type
    • Study Workflow
  • Image Acquisition Protocol
    • Qualified Operators
    • Standardized Acquisition Procedure
      • Number of Images
      • Image Types and Modalities
      • Technical Specifications
  • Clinical Metadata Requirements
  • Data Quality Assessment
    • Quality Criteria
    • Quality Control Process
  • Data Storage and Security
  • References
  • Related Documents

Purpose and Scope​

Define the purpose and scope of this data collection protocol. Specify the type of data collection (retrospective/prospective) and its role in the AI development strategy.

Context and Rationale​

Provide context for this data collection approach. Explain why this type of data collection is necessary and its advantages.

Objectives​

List the primary objectives of this data collection protocol.

  • Objective 1
  • Objective 2

Data Sources​

Describe the data sources to be used.

Source Types​

Describe the types of sources (e.g., clinical studies, public datasets, archives).

Source Selection Criteria​

Define the criteria for selecting data sources.

  1. Criterion 1
  2. Criterion 2

Source Documentation​

Describe the documentation required for each source.

Data Population Characteristics​

Recruitment Strategy​

Describe the recruitment or data acquisition strategy.

Participating Institutions (if applicable)​

List participating institutions and their qualifications.

Ethical and Legal Considerations​

Ethical Approval​

Describe ethical approval requirements (IRB/CEIm).

Informed Consent​

Describe informed consent requirements (if applicable).

Data Protection and Privacy (GDPR Compliance)​

Describe data protection measures and GDPR compliance.

Data Processing Agreements​

Describe data processing agreement requirements (if applicable).

Inclusion Criteria​

List the inclusion criteria for data/participants.

  • Criterion 1
  • Criterion 2

Exclusion Criteria​

List the exclusion criteria for data/participants.

  • Criterion 1
  • Criterion 2

Study Design (if applicable)​

Study Design Type​

Describe the study design (e.g., prospective, observational, single-center, multi-center).

Study Workflow​

Describe the workflow for data collection.

  1. Step 1
  2. Step 2

Image Acquisition Protocol​

Qualified Operators​

Describe the qualifications required for image acquisition personnel.

Standardized Acquisition Procedure​

Describe the standardized procedure for image acquisition.

Number of Images​

Specify the number of images to be captured per case.

Image Types and Modalities​

Describe the image types and modalities to be collected.

Technical Specifications​

Define the technical specifications for images.

ParameterSpecification
Resolution
Format
Quality

Clinical Metadata Requirements​

Describe the clinical metadata to be collected with each case.

FieldRequired/OptionalDescription
Diagnosis
Age
Sex

Data Quality Assessment​

Describe the data quality assessment process.

Quality Criteria​

Define the quality criteria for collected data.

Quality Control Process​

Describe the quality control process.

Data Storage and Security​

Describe data storage and security measures.

References​

List references cited in this document.

  1. Reference 1
  2. Reference 2

Related Documents​

Document IDTitle
R-TF-028-001
R-TF-028-002
R-TF-028-005

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager

ㅤㅤ ㅤㅤ

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T-TF-028-002 AI Development Plan
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T-TF-028-004 Data Annotation Instructions
  • Purpose and Scope
  • Context and Rationale
  • Objectives
  • Data Sources
    • Source Types
    • Source Selection Criteria
    • Source Documentation
  • Data Population Characteristics
    • Recruitment Strategy
    • Participating Institutions (if applicable)
    • Ethical and Legal Considerations
      • Ethical Approval
      • Informed Consent
      • Data Protection and Privacy (GDPR Compliance)
      • Data Processing Agreements
    • Inclusion Criteria
    • Exclusion Criteria
  • Study Design (if applicable)
    • Study Design Type
    • Study Workflow
  • Image Acquisition Protocol
    • Qualified Operators
    • Standardized Acquisition Procedure
      • Number of Images
      • Image Types and Modalities
      • Technical Specifications
  • Clinical Metadata Requirements
  • Data Quality Assessment
    • Quality Criteria
    • Quality Control Process
  • Data Storage and Security
  • References
  • Related Documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)