Introduction
This course is designed to prepare PhD scholars to independently develop a defendable, ethically approved, and supervisor-endorsed research synopsis. It integrates research design, literature synthesis, ethics, sampling, tool development, data planning, and academic communication — aligned with KMU and PMDC research requirements.
Learning Objectives & Outcomes
1. Identify significant research gaps in biomedical sciences.
2. Formulate theory-driven research questions and hypotheses.
3. Select appropriate research designs and methodologies.
4. Develop data collection tools and operational variables.
5. Prepare data analysis and management plans.
6. Defend a complete research synopsis.
Introduction
This 16-week course trains PhD scholars in Basic Medical Sciences to design, conduct, and write a complete systematic review following international standards (PRISMA). The course emphasises hands-on practice from research question formulation to manuscript drafting.
Learning Objectives & Outcomes
By the end of the course, students will be able to:
CLO1: Explain principles and types of literature reviews.
CLO2: Formulate focused research questions using PICO/PECO.
CLO3: Develop and register a systematic review protocol.
CLO4: Design and execute comprehensive search strategies.
CLO5: Screen and select studies using predefined criteria.
CLO6: Extract and manage data systematically.
CLO7: Assess risk of bias and evidence quality.
CLO8: Perform narrative synthesis and basic meta-analysis.
CLO9: Report findings according to PRISMA.
CLO10: Draft a complete systematic review manuscript.
Course Description
This course provides advanced training in the design, ethical conduct, regulatory oversight, execution, and statistical analysis of clinical trials. Emphasis is placed on evidence-based medicine, translational research, and emerging trial methodologies. The course equips PhD scholars with the competencies required to independently design, critically appraise, manage, and report clinical trials in compliance with international ethical and regulatory standards (ICH-GCP, FDA, EMA).
Learning Objectives & Outcomes
The course aims to enable PhD scholars to:
• Understand the scientific and ethical foundations of clinical trials
• Design robust and methodologically sound clinical trials
• Apply advanced randomisation, blinding, and bias-control strategies
• Navigate international and national regulatory frameworks
• Perform appropriate statistical planning and data analysis
• Manage trial data, monitoring, and safety reporting
• Prepare publishable trial protocols and manuscripts
Introduction
This course focuses on the principles and practices of Good Laboratory Practices (GLP), essential for maintaining quality and compliance in laboratory research and diagnostics. It is designed for PhD Students to understand the GLP framework, its regulatory significance, and its practical application in various laboratory settings. The course prepares students to apply GLP standards effectively, ensuring reliable and reproducible results while maintaining safety and ethical considerations.
This course equips PhD students with theoretical knowledge and practical skills to ensure laboratory compliance with GLP standards, preparing them for roles in research, diagnostics, and regulatory environments.
Learning Objectives & Outcomes
1. To introduce the historical context and regulatory framework of GLP.
2. To understand the essential principles and components of GLP, including documentation, quality assurance, and risk management.
3. To develop practical skills for implementing GLP in laboratory settings.
4. To explore the role of GLP in ensuring data integrity and laboratory compliance.
Learning Outcomes
By the end of this course, students will be able to:
1. Explain the purpose and importance of GLP in research and diagnostics.
2. Identify the core components of GLP and their implementation in laboratories.
3. Design and manage quality systems in compliance with GLP standards.
4. Ensure data integrity and ethical conduct in laboratory operations.
5. Evaluate laboratory processes for GLP compliance and prepare for inspections.
Course Description
This course provides structured, competency-based training in Good Clinical Practice (GCP) for PhD scholars engaged in biomedical, clinical, and translational research. The course focuses on ethical conduct, regulatory compliance, participant safety, data integrity, quality assurance, and professional accountability in accordance with ICH-GCP (E6), CIOMS Guidelines, Belmont Report, NIDA GCP framework, and relevant national regulations. The course prepares PhD scholars to function as responsible investigators and future principal investigators.
Course Rationale
PhD scholars frequently engage in biomedical and clinical research involving human participants and identifiable data. This course provides structured training in Good Clinical Practice (GCP) to ensure ethical conduct, participant safety, regulatory compliance, data integrity, and professional accountability. The course is aligned with ICH-GCP (E6), CIOMS Guidelines, Belmont Report, WHO guidance, DRAP Pakistan Clinical Trial Regulations, and NIDA GCP principles to prepare scholars to competently function as responsible investigators and future principal investigators.
Learning Objectives
By the end of this course, PhD scholars will be able to:
1. Define and explain the principles, scope, and regulatory framework of Good Clinical Practice (GCP).
2. Describe the structure, functions, and decision-making processes of Institutional Review Boards (IRBs).
3. Construct and critically appraise informed consent documents and consent processes.
4. Explain confidentiality and privacy safeguards in clinical and biomedical research.
5. Manage and report participant safety issues and adverse events.
6. Describe quality assurance and monitoring systems in clinical research.
7. Develop and review GCP-compliant research protocols and documentation systems.
8. Identify, analyse, and respond to research misconduct.
9. Demonstrate role-specific responsibilities in clinical research.
10. Design ethical recruitment and retention strategies.
11. Explain and apply regulatory requirements related to investigational new drugs (INDs).