Develop a structured understanding of clinical research and its scientific and regulatory framework. Distinguish between different types of clinical studies and analyze their requirements, stakeholders, and contexts of application. Learn how to define strategies for searching scientific literature and identify relevant sources of information. Understand the organization of clinical research infrastructures and the different phases of studies, from planning to execution, monitoring, and closure.

Course coordinator:

Lúcia Domingues

Professor and Clinical Researcher

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Gain skills in clinical research management, understanding its specific challenges and requirements. Apply strategic and operational management principles to the planning, organization, and evaluation of projects. Use key concepts, methodologies, and techniques of project management in a clinical context, ensuring compliance with Good Clinical Practice. Integrate quality management systems into the conduct of clinical research projects.

Course coordinator:

   Ana Dias

   Universidade de Aveiro

Understand the ethical principles and legal framework of clinical research involving human subjects. Analyze ethical implications in real-world scenarios, including risk–benefit balance, the use of placebo, and potential conflicts of interest. Recognize the responsibilities of different stakeholders and the importance of Good Clinical Practice, ethical review, and scientific integrity. Explore informed consent as a process and the inclusion of vulnerable populations. Apply these principles to the organization of a clinical research project, from planning to execution, monitoring, and closure.

Course coordinator:

Lúcia Domingues

Professor and Clinical Researcher

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Explore the fundamental principles of epidemiology and clinical research methodologies that underpin research and intervention projects. Develop a critical approach to scientific results and recognize the limitations of available evidence. Strengthen your ability to interpret scientific questions independently, fostering critical thinking and scientific curiosity.

Course coordinator:

Ana Rodrigues

Principal Investigator, MD, PhD

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Apply statistical methods to the planning of clinical studies, including selecting appropriate analyses and calculating sample size. Estimate effects and perform hypothesis testing to assess statistical significance. Use predictive models and evaluate the suitability of different statistical approaches. Develop a critical approach and interpret statistical results in clinical contexts.

Course coordinator:

   Vera Aleixo

   Universidade de Aveiro

Gain an understanding of the principles of quality management in healthcare, including funding models and current challenges in service delivery. Analyze quality dimensions, indicators, and standards, as well as patient-centered practices such as satisfaction assessment and complaint management. Learn about regulatory frameworks, accreditation and certification processes, and the role of auditing in healthcare services. Strengthen skills in research, synthesis, and communication.

Course coordinator:

   Maria Teresa Herdeiro

   Universidade de Aveiro

Explore the principles of regulation of medicines and health products, including the role of regulatory authorities and European systems, with a focus on the national context. Analyze key information associated with medicines, such as summaries of product characteristics, labeling, and patient information leaflets. Deepen your understanding of regulatory frameworks for different types of products, including advanced therapies, biologics, generics, and medical devices. Understand the importance of drug safety monitoring and post-authorization studies. Strengthen skills in research, synthesis, and communication.

Course coordinator:

   Maria Teresa Herdeiro

   Universidade de Aveiro

Analyze the organization of healthcare systems, with a focus on the Portuguese context and the structure of the National Health Service. Compare international models and understand the different levels of care delivery and how they are organized. Explore key concepts in healthcare management, including financing, operations, quality, patient safety, innovation, and performance evaluation. Recognize the role of healthcare system organization in the management of clinical research.

Course coordinator:

   Ana Gabriela Henriques

   Universidade de Aveiro

Explore the role of biobanks as key infrastructures supporting clinical research. Analyze the ethical, legal, and social aspects of their implementation and operation. Apply methodologies and best practices in biobank management and develop skills for planning biobanks. Reflect on their importance in advancing clinical research.

Course coordinator:

   Ana Gabriela Henriques

   Universidade de Aveiro

2^nd Year

Deepen your knowledge of data management in clinical research, from study setup to data organization and processing. Explore the key activities involved, including data collection, editing, and database structuring, with a focus on electronic systems. Develop a data management plan and understand the infrastructures required to support the entire process. Analyze current trends and emerging changes in the field.

Course coordinator:

Lúcia Domingues

Professor and Clinical Researcher

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2^nd Year

Build skills in identifying and analyzing funding sources for clinical research. Plan and structure grant applications, including their technical components and budget development. Prepare reports throughout the study lifecycle, from implementation to completion. Communicate research findings through scientific writing, poster preparation, and oral presentations.

Course coordinator:

   Bruno Gago

   Universidade de Aveiro

2^nd Year

Consolidate your skills through a year-long dissertation, internship, or project, preparing you for real-world clinical research settings. Apply advanced knowledge in quality management, study planning, and data collection and analysis strategies. Contribute to identifying funding opportunities and preparing proposals, as well as sample monitoring and biobank management. Integrate knowledge to address complex challenges and actively contribute to clinical research. Strengthen your autonomy, research, synthesis, and scientific communication skills.

Course coordinator:

Lúcia Domingues

Professor and Clinical Researcher

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