MEDT08- LESSON 2

Clinical Laboratory Management

Good Clinical Practice (GCP)

Ensuring data collected during clinical trials are credible and that the participants’ rights, safety, and well-being are protected.

Key Aspect of GCP: Ethical Principles

It emphasizes the importance of obtaining informed consent from participants

Key Aspect of GCP: Trial Design and Conduct

This includes selection appropriate methodologies, defining inclusion and exclusion criteria, and ensuring the scientific validity of the study

Key Aspect of GCP: Informed Consent

Their consent must be documented and obtained freely

Key Aspect of GCP: Data Integrity

All data must be accurately recorded, handled, and stored

Key Aspect of GCP: Monitoring and Auditing

This helps identify and address any issues or deviations from the protocol

Key Aspect of GCP: Safety Reporting

Reports any adverse events or side effects experience by the participants to ensure the participant’s safety and to make necessary adjustments to the trial

Key Aspect of GCP: Qualifications and Training

All personnel involved in the clinical trial must be appropriately qualified and trained

Key Aspect of GCP: Regulatory Compliance

Trials must comply with local and international regulations and guidelines. 

Good Laboratory Practice (GLP) 

Ensures quality, consistency, and reliability of laboratory studies, particularly in the context of pre clinical and clinical research.

Key Components of GLP: Organizational Structure and Personnel

• Qualified Staff

• Clear Roles and Responsibilities

Key Components of GLP: Study Protocols

• Detailed Protocols

• Documentation 

Key Components of GLP: Standard Operating Procedures (SOP’s)

• Consistency

• Updated

Key Components of GLP: Facilities and Equipment

• Suitable Environment

• Proper Equipment

Key Components of GLP: Test Systems and Samples

• Proper Handling

• Documentation

Key Components of GLP: Quality Assurance

• Monitoring

• Audit

Key Components of GLP: Data Management

• Accurate Records

• Data Integrity

Key Components of GLP: Reporting

• Study reports

• Transparency

Key Components of GLP: Regulatory Compliance

• Adherence to Guidelines

Different Type of Management

• Traditional

• Contemporary

Traditional Management

Hierarchical, organized and disciplined. The power floes vertically and upward, the employees are departmentalized and follow a chain of command

Contemporary Management

Top management support and serve other managers and employees through a process called empowerment, just as the organization ultimately exists to serve its customers and clients.

Common responsibilities of managers across different sectors

• Leading a team

• Training Employees

• Making Decisions

• Managing Conflict

• Managing their department’s budget

• Conducting performance review

• Hiring new employees

Different Type of Managers

• Top Managers

• General Managers

• Line Managers

• Team Managers

Top Managers

They are involved with their company’s overall strategy. They are responsible for making sure that different tasks and project align with the overarching mission of the company.

General Managers

Responsible for a variety of management tasks including overseeing the product production. Their overall goal is to increase the company’s revenue.

Line Managers

Responsible for achieving specific outputs. They often communicate with a company’s upper management and report results to them.

Team Managers

Referred to as supervisors and responsible for overseeing specific groups or function within the organization. They keep the teams on track

Role of Laboratory in Healthcare Setting

Laboratory findings serve as a turning point in a patient’s care.

Laboratory contributions to healthcare

• Quality Control

• Proficiency testing

• Laboratory hires specially trained personnel

• Laboratory documents everything

• Laboratory asses their own quality

Types of Diagnostic Laboratory

• Clinical Laboratories

• Public Health Laboratories

• Research Laboratories

Clinical Laboratory

It is the most common type of diagnostic laboratory. They perform tests on patient samples such as blood, urine, and tissue to aid in diagnosing and treating diseases. 

Public Health Laboratory

Focuses on monitoring and controlling infectious diseases. They are the responsible for identifying and tracking outbreaks of infectious diseases. They monitor the effectiveness of public health interventions.

Research Laboratories

Focuses on studying the underlying mechanisms of diseases and developing new diagnostic and treatment options